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Due to sponsor decision
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| Name | Class |
|---|---|
| Artiva Biotherapeutics, Inc. | INDUSTRY |
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AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL.
The study will start with a safety run-in exploring AFM13/AB-101 combination treatment in subjects with classical HL. Two dose levels of AFM13 and AB-101, respectively, will be tested in 4 cohorts. Cohort 1 and 2 will enroll in parallel. Enrolment into Cohort 3 and 4 will start only if the combination treatment has been well tolerated.
Following the safety run-in observation period, a thorough risk-benefit analysis will be performed to determine 2 of the 4 cohorts/dose levels that will be further evaluated in the main part of the study which will also include subjects with classical HL and will follow a Simon two-stage design.
An additional exploratory cohort (Cohort 5) will enroll subjects with select CD30-positive PTCL subtypes after completion of the safety run-in.
All subjects will be treated with AFM13/AB-101 for a maximum of 3 cycles (cycle length is 48-days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety run-in in Hodgkin Lymphoma | Experimental | 4 safety run-in cohorts:
|
|
| Dose Level A in Hodgkin Lymphoma | Experimental | Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level A (selected from cohort 1-4 of Safety run-in) |
|
| Dose Level B in Hodgkin Lymphoma | Experimental | Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level B (selected from cohort 1-4 of Safety run-in) |
|
| Exploratory: AFM13 + AB-101 on CD30-positive PTCL | Experimental | AFM13 + AB-101 on select CD30-positive PTCL subtypes (Dose Level A or B) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFM13 | Drug | anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by Independent Radiology Committee | Best ORR (complete response (CR) + partial response [PR]) by Independent Radiology Committee (IRC) based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification. A participant will be assumed as a responder if he/she achieves complete or partial response at any postbaseline visit. | Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response by Independent Radiology Committee | Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed by Independent Radiology Committee. | Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wunderle Lydia, MD | Affimed Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| O'Neal Comprehensive Cancer Center at UAB | Birmingham | Alabama | 35294 | United States | ||
| City of Hope National Medical Center |
The three experimental Arms/Groups: 'Dose Level A in Hodgin Lymphoma', 'Dose Level B in Hodgin Lymphoma' and 'Exploratory: AFM13 + AB-101 on CD30-positive PTCL' were not enrolled due to the decision to terminate this study earlier, which was based solely on the financial situation of the company and was not related to the safety or efficacy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety run-in Cohort 1 | Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 3, 2024 | Jul 14, 2025 |
Not provided
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| AB-101 | Drug | NK cell therapy, intravenous infusion |
|
| Cyclophosphamide | Drug | Lymphodepleting chemotherapy, intravenous infusion |
|
| Fludarabine | Drug | Lymphodepleting chemotherapy, intravenous infusion |
|
| Interleukin-2 | Drug | Immune cytokine, subcutaneously |
|
| Complete Response Rate (CRR) by Independent Radiology Committee | Complete Response Rate based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification. | Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months) |
| ORR by Investigator Based on PET-CT as Assessed by the Lugano Classification | ORR (CR + PR) by Investigator based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification | Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months) |
| Duration of Response by Investigator | Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed locally by the Investigator. | Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months) |
| Incidence of Subjects Receiving Subsequent Transplant | The number of subjects receiving subsequent transplant will be assessed and summarized by percentage rates | Throughout study completion (up to 20 months) |
| Frequency of Subjects With Study Drug Related TEAEs | The number of subjects with study-drug related (AFM13 or AB-101) treatment-emergent adverse events (TEAEs) | From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months) |
| Frequency of Subjects With Serious Treatment Emergent Adverse Events | The number of subjects who had serious treatment emergent adverse events. | From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months) |
| Frequency of Subjects Developing Anti-drug Antibodies (ADAs) Against AFM13 | The number of subjects developing anti-drug antibodies (ADAs) against AFM13 | During treatment cycles (up to 6 months) |
| Progression-free Survival (PFS) by Independent Radiology Committee | Progression-free survival (PFS) defined as time from first treatment (AFM13/AB-101) received until progressive disease (PD). Subjects who started a new anti-lymphoma therapy prior to a documented progressive disease were censored at the last disease assessment prior to initiation of new anti-lymphoma therapy. Subjects who discontinued the study before the first assessment of progressive disease or death were censored at their last disease assessment. | From the first treatment received until the first progression disease assessed by IRC or death. |
| Overall Survival | Overall Survival (OS) was defined as (date of death - date of first dose)/30.4375. Patients alive at the end of study will be censored on the last date of observation. | From the first treatment received until the death. |
| Duarte |
| California |
| 91010 |
| United States |
| UC Irvine Health | Orange | California | 92868 | United States |
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Beth Israel Deaconess Medical | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| UNC Immunotherapy Team, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania, Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| FG001 | Safety run-in Cohort 2 | Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| FG002 | Safety run-in Cohort 3 | Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| FG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| COMPLETED |
|
| NOT COMPLETED |
|
Safety Analysis Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Safety run-in Cohort 1 | Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| BG001 | Safety run-in Cohort 2 | Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| BG002 | Safety run-in Cohort 3 | Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| BG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) by Independent Radiology Committee | Best ORR (complete response (CR) + partial response [PR]) by Independent Radiology Committee (IRC) based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification. A participant will be assumed as a responder if he/she achieves complete or partial response at any postbaseline visit. | The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1. | Posted | Count of Participants | Participants | Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles. |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response by Independent Radiology Committee | Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed by Independent Radiology Committee. | All patients in the Safety Run In Set who had a response (CR or PR) assessed by the independent review committee. | Posted | Median | 95% Confidence Interval | months | Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) by Independent Radiology Committee | Complete Response Rate based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification. | The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1. | Posted | Count of Participants | Participants | Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | ORR by Investigator Based on PET-CT as Assessed by the Lugano Classification | ORR (CR + PR) by Investigator based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification | The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1. | Posted | Count of Participants | Participants | Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response by Investigator | Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed locally by the Investigator. | All patients in the Safety Run In Set who had a response (CR or PR) assessed by the investigator. | Posted | Median | 95% Confidence Interval | months | Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Subjects Receiving Subsequent Transplant | The number of subjects receiving subsequent transplant will be assessed and summarized by percentage rates | The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1. | Posted | Count of Participants | Participants | Throughout study completion (up to 20 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Subjects With Study Drug Related TEAEs | The number of subjects with study-drug related (AFM13 or AB-101) treatment-emergent adverse events (TEAEs) | The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen. | Posted | Count of Participants | Participants | From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Subjects With Serious Treatment Emergent Adverse Events | The number of subjects who had serious treatment emergent adverse events. | The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen. | Posted | Count of Participants | Participants | From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Subjects Developing Anti-drug Antibodies (ADAs) Against AFM13 | The number of subjects developing anti-drug antibodies (ADAs) against AFM13 | The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen. | Posted | Count of Participants | Participants | During treatment cycles (up to 6 months) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) by Independent Radiology Committee | Progression-free survival (PFS) defined as time from first treatment (AFM13/AB-101) received until progressive disease (PD). Subjects who started a new anti-lymphoma therapy prior to a documented progressive disease were censored at the last disease assessment prior to initiation of new anti-lymphoma therapy. Subjects who discontinued the study before the first assessment of progressive disease or death were censored at their last disease assessment. | The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1. | Posted | Median | 95% Confidence Interval | months | From the first treatment received until the first progression disease assessed by IRC or death. |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival (OS) was defined as (date of death - date of first dose)/30.4375. Patients alive at the end of study will be censored on the last date of observation. | The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1. | Posted | Median | 95% Confidence Interval | months | From the first treatment received until the death. |
|
From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)
The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety run-in Cohort 1 | Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously | 1 | 6 | 2 | 6 | 6 | 6 |
| EG001 | Safety run-in Cohort 2 | Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously | 4 | 7 | 5 | 7 | 7 | 7 |
| EG002 | Safety run-in Cohort 3 | Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously | 1 | 6 | 4 | 6 | 6 | 6 |
| EG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously | 0 | 6 | 5 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cytomegalovirus Infection Reactivation | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cytomegalovirus Oesophagitis | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cytomegalovirus Viraemia | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pseudomonas Infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Diffuse Large B-Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 28.0 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Anal Fistula | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Anal Incontinence | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Oroantral Fistula | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Rectal Fissure | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 28.0 | Systematic Assessment | General Disorders And Administration Site Conditions |
|
| Pyrexia | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment | General Disorders And Administration Site Conditions |
|
| Chills | General disorders | MedDRA Version 28.0 | Systematic Assessment | General Disorders And Administration Site Conditions |
|
| Oedema Peripheral | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Catheter Site Pain | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Facial Pain | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Injection Site Induration | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cytomegalovirus Infection Reactivation | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Enterocolitis Infectious | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Enterovirus Infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hcov-Oc43 Infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Parainfluenzae Virus Infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Staphylococcal Bacteraemia | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Brain Fog | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Extrapyramidal Disorder | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Muscle Spasticity | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Restless Legs Syndrome | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Upper-Airway Cough Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Failure To Thrive | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Skin Mass | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Anti-Hla Antibody Test | Investigations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Lipase Increased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Protein Total Decreased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Scleral Hyperaemia | Eye disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Strabismus | Eye disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cytokine Release Syndrome | Immune system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Heavy Menstrual Bleeding | Reproductive system and breast disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA Version 28.0 | Systematic Assessment |
|
The decision to terminate this study was based solely on the financial situation of the company and was not related to the safety or efficacy. Given this limitation, the results of the time to event endpoints are premature.
The sponsor has the right to review communications for 90 days prior to public release (whereby the sponsor may ask to consider modifications to ensure necessary protection of sponsor's IP). Any publication shall be not made before the first multi-centre publication if the study is a part of a multi-centred clinical trial. Also, if a publication concerns the analyses of data from a multi-centred clinical trial, the communication shall make reference to the relevant multi-centre publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Affimed GmbH | +49 621 560030 | trials@affimed.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 23, 2024 | Jul 14, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D006689 | Hodgkin Disease |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723551 | AFM13 |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Safety run-in Cohort 3 | Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| OG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
|
|
| OG002 | Safety run-in Cohort 3 | Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| OG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
|
|
| OG002 | Safety run-in Cohort 3 | Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| OG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
|
|
| OG002 | Safety run-in Cohort 3 | Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| OG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
|
|
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| OG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
|
|
| Safety run-in Cohort 3 |
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| OG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
|
|
| Safety run-in Cohort 3 |
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| OG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
|
|
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| OG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
|
|
| OG002 | Safety run-in Cohort 3 | Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| OG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
|
|
| Safety run-in Cohort 3 |
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
| OG003 | Safety run-in Cohort 4 | Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously |
|
|