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This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) SPEAR™ T cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| afamitresgene autoleucel (previously ADP-A2M4) | Genetic | Single infusion of autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) (Cohort 1) | Percentage of participants with confirmed tumor response (complete [CR] or partial [PR] response) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Independent Radiologist review (Cohort 1) | From T-cell infusion until disease progression/recurrence as of data cut off (up to 2 years). Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) Including Serious Adverse Events (SAE), SAE, and Adverse Events of Special Interest (AESI) (Cohort 1) | An AE was defined as any untoward medical occurrence in a subject or clinical study participant temporally associated with the use of the study intervention, whether or not considered related to the study intervention. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants with AEs (including SAE), SAE and AESI including cytokine release syndrome, neurotoxicity, ICANS, prolonged cytopenia are presented. |
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Key Inclusion Criteria
Lansky Score ≥60%.
• Left ventricular ejection fraction (LVEF) ≥50%.
Note: other protocol defined Inclusion criteria may apply
Key Exclusion Criteria:
Note: other protocol defined Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Dejka Araujo, MD | MD Anderson Cancer Center; Houston TX 77030 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Stanford Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38554725 | Background | D'Angelo SP, Araujo DM, Abdul Razak AR, Agulnik M, Attia S, Blay JY, Carrasco Garcia I, Charlson JA, Choy E, Demetri GD, Druta M, Forcade E, Ganjoo KN, Glod J, Keedy VL, Le Cesne A, Liebner DA, Moreno V, Pollack SM, Schuetze SM, Schwartz GK, Strauss SJ, Tap WD, Thistlethwaite F, Valverde Morales CM, Wagner MJ, Wilky BA, McAlpine C, Hudson L, Navenot JM, Wang T, Bai J, Rafail S, Wang R, Sun A, Fernandes L, Van Winkle E, Elefant E, Lunt C, Norry E, Williams D, Biswas S, Van Tine BA. Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial. Lancet. 2024 Apr 13;403(10435):1460-1471. doi: 10.1016/S0140-6736(24)00319-2. Epub 2024 Mar 27. | |
| 32002290 |
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NOTE: Cohort 1 participant Flow, demographics and efficacy cut off was 29Aug2022; Cohort 1 safety cut off was 29Mar2023
This was a Phase 2, single-arm, open-label study of afamitresgene autoleucel in HLA-A*02+ participants with MAGE-A4 expressing metastatic or inoperable (advanced) synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) (Cohort 1). Eligible participants received between 1.0 × 10^9 to 10.0 × 10^9 transduced cells of afamitresgene autoleucel, administered as a single IV infusion following lymphodepletion with fludarabine and cyclophosphamide.
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| ID | Title | Description |
|---|---|---|
| FG000 | Synovial Sarcoma | Eligible participants with metastatic or inoperable (advanced) synovial sarcoma received afamitresgene autoleucel as a single infusion in Cohort 1 (as of data cut off) |
| FG001 | MRCLS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 5, 2021 | May 23, 2024 |
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| AEs, SAEs, and AESIs were collected at each visit from the start of lymphodepletion of the first subject until the last subject discontinued the interventional phase in cohort 1 as of the safety cut off (up to 3.2 years). |
| The Number of Participants With Replication Competent Lentivirus (RCL) | The presence of RCL was assessed by qPCR targeting a segment of the vesicular stomatitis virus glycoprotein (VSV G) coding sequence. | From T-cell infusion to months 3, 6, and 12 post-infusion, then annually post-infusion (up to 2.8 years as of the data cut off). |
| Insertional Oncogenesis (IO) | Deoxyribonucleic acid (DNA) from participants peripheral blood mononuclear cell (PBMC) samples was subjected to lentiviral vector integration site analysis by next-generation sequencing, thus evaluating both the clonality status of the transduced cell population and the genomic localization of individual integration sites. The count of participants with integration sites representing more than 5% of all unique sites is presented. | From 10 months post T-cell infusion up to 20 months post T-cell infusion (as of the data cut off) |
| Best Overall Response (BOR) (Cohort 1) | BOR is the best response recorded from the start of T-cell infusion until disease progression/recurrence as assessed by Independent Radiologist review. Response categories are confirmed CR, confirmed PR, stable disease and confirmed progressive disease (PD). Best overall response is a stable disease, if CR or PR are unconfirmed. | From T-cell infusion until disease progression/recurrence as of data cut off (up to 2.6 years). Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression. |
| Time to Response (TTR) (Cohort 1) | TTR was defined as the interval (weeks) from the date of T-cell infusion to the earliest date of the first documented confirmed CR or confirmed PR as assessed by Independent Radiologist review. TTR (in weeks) = [date of initial confirmed CR or PR - date of T-cell infusion + 1]/7. | From T-cell infusion until first documented confirmed CR or confirmed PR. Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression. |
| Duration of Response (DoR) (Cohort 1) | DoR (in months) is defined as ((date of PD (or censoring) - date of initial confirmed CR/PR + 1)/365.25)*12 as assessed by Independent Radiologist review. Outcome Measure not yet reached as participants are ongoing in study | From initial confirmed response (CR or PR) until PD (or censored date) as of data cut off. |
| Progression Free Survival (PFS) (Cohort 1) | PFS is defined as the time from T-cell infusion to the date of the first documentation of PD or death due to any cause, whichever occurs first, as assessed by Independent Radiologist review. PFS (in weeks) was calculated as (date of PD/death [or censored date] - first T-cell infusion date + 1)/7. | From T-cell infusion until first documented PD or death due to any cause (or censored date), whichever occurs first, as of data cut off (up to 2.6 years). Response was assessed at Week 4, 8,12,16, 24, and every 2 months until confirmed PD |
| Overall Survival (OS) (Cohort 1) | OS is defined as the time from the date of T-cell infusion to the date of death (due to any reason) or censored date. OS in months was calculated as ((death date - first T-cell infusion date + 1)/365.25)*12. Outcome Measure not yet reached as participants are ongoing in study | From T-cell infusion to death due to any reason (or censored date) as of data cut off (up to 2.6 years). |
| Peak Persistence (Cohort 1) | Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC). | From T-cell infusion to 3.2 years (as of data cut off). |
| Time Taken to Achieve Peak Expansion of Genetically Engineered T-cells in PBMCs | Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry | 2.5 years |
| Quantitation of Genetically Engineered T-cells in PBMCs | Quantitation of genetically engineered T-cells in PBMCs by flow cytometry | 2.5 years |
| Time Taken to Achieve Peak Expansion of Genetically Engineered T-cells in PBMCs | Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by qPCR | 2.5 years |
| In Vitro Diagnostic (IVD) Assay for Screening | Development and validation of the MAGE-A4 antigen expression companion diagnostic assay | 2.5 years |
| Palo Alto |
| California |
| 94305 |
| United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 33612 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Northwestern University Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | United States |
| National Cancer Institute | Bethesda | Maryland | 20892 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Vanderbilt | Nashville | Tennessee | 37212 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Fred Hutch | Seattle | Washington | 98109 | United States |
| Medical College of WI Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Leon Berard | Lyon | France |
| Hospital Haut Leveque, CHU Bordeaux | Pessac | 33604 | France |
| Gustave Roussy Cancer Center | Villejuif | 94805 | France |
| Hospital Universitari Vall D'Hebron | Barcelona | Catalonia | 119-129 | Spain |
| Start Madrid-FJD, Fundación Jimѐnez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| UCLH Cancer Clinical Trials Unit | London | NW1 2PG | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Derived |
| Sanderson JP, Crowley DJ, Wiedermann GE, Quinn LL, Crossland KL, Tunbridge HM, Cornforth TV, Barnes CS, Ahmed T, Howe K, Saini M, Abbott RJ, Anderson VE, Tavano B, Maroto M, Gerry AB. Preclinical evaluation of an affinity-enhanced MAGE-A4-specific T-cell receptor for adoptive T-cell therapy. Oncoimmunology. 2019 Nov 24;9(1):1682381. doi: 10.1080/2162402X.2019.1682381. eCollection 2020. |
Eligible participants with metastatic or inoperable (advanced) MRCLS received afamitresgene autoleucel as a single infusion in Cohort 1 (as of data cut off)
| Received Afamitresgene Autoleucel |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants who received T-cell infusion in cohort 1 as of data cut off
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| ID | Title | Description |
|---|---|---|
| BG000 | Synovial Sarcoma | Eligible participants with metastatic or inoperable (advanced) synovial sarcoma received afamitresgene autoleucel as a single infusion in Cohort 1 (as of data cut off) |
| BG001 | MRCLS | Eligible participants with metastatic or inoperable (advanced) MRCLS received afamitresgene autoleucel as a single infusion in Cohort 1 (as of data cut off) |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Overall Response Rate (ORR) (Cohort 1) | Percentage of participants with confirmed tumor response (complete [CR] or partial [PR] response) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Independent Radiologist review (Cohort 1) | Participants who received afamitresgene autoleucel | Posted | Number | 95% Confidence Interval | percentage of participants | From T-cell infusion until disease progression/recurrence as of data cut off (up to 2 years). Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression. |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Adverse Events (AE) Including Serious Adverse Events (SAE), SAE, and Adverse Events of Special Interest (AESI) (Cohort 1) | An AE was defined as any untoward medical occurrence in a subject or clinical study participant temporally associated with the use of the study intervention, whether or not considered related to the study intervention. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants with AEs (including SAE), SAE and AESI including cytokine release syndrome, neurotoxicity, ICANS, prolonged cytopenia are presented. | Participants who received afamitresgene autoleucel | Posted | Count of Participants | Participants | AEs, SAEs, and AESIs were collected at each visit from the start of lymphodepletion of the first subject until the last subject discontinued the interventional phase in cohort 1 as of the safety cut off (up to 3.2 years). |
| |||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With Replication Competent Lentivirus (RCL) | The presence of RCL was assessed by qPCR targeting a segment of the vesicular stomatitis virus glycoprotein (VSV G) coding sequence. | Participants who received afamitresgene autoleucel and had a sample tested for VSV-G by qPCR (RCL) at or after 3 months post-infusion | Posted | Count of Participants | Participants | From T-cell infusion to months 3, 6, and 12 post-infusion, then annually post-infusion (up to 2.8 years as of the data cut off). |
|
| ||||||||||||||||||||||||||||||
| Secondary | Insertional Oncogenesis (IO) | Deoxyribonucleic acid (DNA) from participants peripheral blood mononuclear cell (PBMC) samples was subjected to lentiviral vector integration site analysis by next-generation sequencing, thus evaluating both the clonality status of the transduced cell population and the genomic localization of individual integration sites. The count of participants with integration sites representing more than 5% of all unique sites is presented. | Participants who received afamitresgene autoleucel and had a sample analyzed for IO | Posted | Count of Participants | Participants | From 10 months post T-cell infusion up to 20 months post T-cell infusion (as of the data cut off) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Best Overall Response (BOR) (Cohort 1) | BOR is the best response recorded from the start of T-cell infusion until disease progression/recurrence as assessed by Independent Radiologist review. Response categories are confirmed CR, confirmed PR, stable disease and confirmed progressive disease (PD). Best overall response is a stable disease, if CR or PR are unconfirmed. | Participants who received afamitresgene autoleucel | Posted | Count of Participants | Participants | From T-cell infusion until disease progression/recurrence as of data cut off (up to 2.6 years). Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) (Cohort 1) | TTR was defined as the interval (weeks) from the date of T-cell infusion to the earliest date of the first documented confirmed CR or confirmed PR as assessed by Independent Radiologist review. TTR (in weeks) = [date of initial confirmed CR or PR - date of T-cell infusion + 1]/7. | Participants who received afamitresgene autoleucel and had a confirmed CR or confirmed PR as of data cut off. | Posted | Median | 95% Confidence Interval | Weeks | From T-cell infusion until first documented confirmed CR or confirmed PR. Response was assessed at Week 4, Week 8, Week 12, Week 16, and Week 24, and every 2 months +/- 28 days until confirmed disease progression. |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) (Cohort 1) | DoR (in months) is defined as ((date of PD (or censoring) - date of initial confirmed CR/PR + 1)/365.25)*12 as assessed by Independent Radiologist review. Outcome Measure not yet reached as participants are ongoing in study | Not Posted | From initial confirmed response (CR or PR) until PD (or censored date) as of data cut off. | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) (Cohort 1) | PFS is defined as the time from T-cell infusion to the date of the first documentation of PD or death due to any cause, whichever occurs first, as assessed by Independent Radiologist review. PFS (in weeks) was calculated as (date of PD/death [or censored date] - first T-cell infusion date + 1)/7. | Participants who received afamitresgene autoleucel | Posted | Median | 95% Confidence Interval | Weeks | From T-cell infusion until first documented PD or death due to any cause (or censored date), whichever occurs first, as of data cut off (up to 2.6 years). Response was assessed at Week 4, 8,12,16, 24, and every 2 months until confirmed PD |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) (Cohort 1) | OS is defined as the time from the date of T-cell infusion to the date of death (due to any reason) or censored date. OS in months was calculated as ((death date - first T-cell infusion date + 1)/365.25)*12. Outcome Measure not yet reached as participants are ongoing in study | Not Posted | From T-cell infusion to death due to any reason (or censored date) as of data cut off (up to 2.6 years). | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Peak Persistence (Cohort 1) | Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC). | Participants who received afamitresgene autoleucel | Posted | Median | Full Range | DNA copies/microgram | From T-cell infusion to 3.2 years (as of data cut off). |
|
| |||||||||||||||||||||||||||||
| Secondary | Time Taken to Achieve Peak Expansion of Genetically Engineered T-cells in PBMCs | Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry | Not Posted | 2.5 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Quantitation of Genetically Engineered T-cells in PBMCs | Quantitation of genetically engineered T-cells in PBMCs by flow cytometry | Not Posted | 2.5 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Time Taken to Achieve Peak Expansion of Genetically Engineered T-cells in PBMCs | Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by qPCR | Not Posted | 2.5 years | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | In Vitro Diagnostic (IVD) Assay for Screening | Development and validation of the MAGE-A4 antigen expression companion diagnostic assay | Not Posted | 2.5 years | Participants |
AEs and SAEs were collected at each visit from the start of lymphodepletion of the first subject until the last subject discontinued the interventional phase in cohort 1 as of the safety cut off (up to 3.2 years).
Adverse events are reported for all participants who received afamitresgene autoleucel
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 | Synovial Sarcoma | Eligible participants with metastatic or inoperable (advanced) synovial sarcoma received afamitresgene autoleucel as a single infusion in Cohort 1 (as of data cut off) | 24 | 44 | 23 | 44 | 44 | 44 |
| EG001 | MRCLS | Eligible participants with metastatic or inoperable (advanced) MRCLS received afamitresgene autoleucel as a single infusion in Cohort 1 (as of data cut off) | 7 | 8 | 3 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MEDDRA v 23 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MEDDRA v 23 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MEDDRA v 23 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA v 23 | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MEDDRA v 23 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Influenza-like illness | General disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Respiratory complication associated with device | General disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA v 23 | Systematic Assessment |
| |
| Lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA v 23 | Systematic Assessment |
| |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA v 23 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Superior vena cava occlusion | Vascular disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MEDDRA v 23 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphocyte count decreased | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MEDDRA v 23 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MEDDRA v 23 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Chills | General disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Pain | General disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MEDDRA v 23 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA v 23 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA v 23 | Systematic Assessment |
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| Embolism | Vascular disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA v 23 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MEDDRA v 23 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA v 23 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Management | Adaptimmune | +1 (215) 825 9260 | clinicaltrials@adaptimmune.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 21, 2024 | May 23, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013584 | Sarcoma, Synovial |
| D018208 | Liposarcoma, Myxoid |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008080 | Liposarcoma |
| D018205 | Neoplasms, Adipose Tissue |
Not provided
Not provided
| >=65 years |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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