Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CA167925 | Other Identifier | NIH |
Not provided
Not provided
Not provided
Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of N-803 in patients with relapsed or refractory multiple myeloma.
The purpose of this study is to evaluate the safety, determine the Maximum Tolerated Dose (MTD) or the Minimum Efficacious Dose (MED) and characterize the immunogenicity and pharmacokinetic profile of N-803 in treated patients. The effect of N-803 on the peripheral absolute lymphocyte counts and white blood cell counts, the number and phenotype of peripheral blood T (total and subsets) and NK cells will be evaluated. The anti-tumor responses of N-803 will also be assessed in this trial.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: N-803 - IV 1 ug/kg | Experimental |
| |
| Cohort 2: N-803 - IV 3 ug/kg | Experimental |
| |
| Cohort 3: N-803 - IV 6 ug/kg | Experimental |
| |
| Cohort 4: N-803 - IV 10 ug/kg | Experimental |
| |
| Cohort 5: N-803 - SQ 10 ug/kg | Experimental |
| |
| Cohort 6: N-803 - SQ 15 ug/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-803 | Biological | Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | For phase I - Number of Participants with Treatment Emergent Adverse Events that occur or worsen after the first dose of study treatment. | 24 weeks |
| Disease Response Rate of Treated Patients | CR- negative SIFE and UIFE, disappearance of any soft tissue plasmacytomas, and < or = to 5% plasma cells in bone marrow VGPR - either + SIFE and UIFE and - SPEP and UPEP or reduction in serum M-protein > or = to 90% and urine m-protein level <100mg per 24h PR - if measurable serum an urine m-protein them reduction of serum m-protein by >=50% and reduction in 24h urinary m protein by >=90% or to <200mg per 24h if unmeasurable serum and urine m-protein then >= 50% decrease in the difference between involve and uninvolved FLC levels If unmeasurable serum and urine m-protein and serum FLC assay then >= 50% reduction in plasma cells, provide baseline bone marrow plasma cell percentage was >=30% In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required PD - defined via International Myeloma Working Group uniform response criteria: disease progression SD - not meeting criteria for CR, VGPR, PR or PD | Starts at Week 11 - 12 and Week 23 - 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of the Pharmacokinetic Profile - Half-life (t½) | Half-life (t½) - The period of time required for the concentration or amount of drug in the body to be reduced by one-half. | PK timepoint up to 72 hours +/- 6 hours |
| Characterization of the Pharmacokinetic Profile - Time of the Observed Maximum Concentration (Tmax) |
Not provided
ENTRY CRITERIA:
DISEASE CHARACTERISTICS:
Confirmed diagnosis of relapsed/refractory multiple myeloma after treatment with at least two different previous regimens.
Measurable disease as defined by at least one of the following:
PRIOR/CONCURRENT THERAPY:
PATIENT CHARACTERISTICS:
Performance Status
• ECOG 0, 1, or 2
Bone Marrow Reserve
Renal Function
• Glomerular Filtration Rate (GFR) > 40mL/min or Serum creatinine ≤ 1.5 X ULN
Hepatic Function
Cardiovascular
Pulmonary
• Normal clinical assessment of pulmonary function
Other
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hing C Wong, PhD | Altor BioScience | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States | ||
| Washington University School of Medicine |
Only the Phase 1b portion of the study enrolled participants. The study was terminated early, so no participants were enrolled on the Phase 2 portion of the study
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: N-803 - IV 1 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| FG001 | Cohort 2: N-803 - IV 3 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| FG002 | Cohort 3: N-803 - IV 6 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| FG003 | Cohort 4: N-803 - IV 10 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| FG004 | Cohort 5: N-803 - SQ 10 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| FG005 | Cohort 6: N-803 - SQ 15 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| FG006 | Cohort 7: N-803 - SQ 20 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: ALT-803 - IV 1 ug/kg | ALT-803: Intravenous infusion for cohort 1, 2, 3 and 4; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| BG001 | Cohort 2: ALT-803 - IV 3 ug/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Treatment Emergent Adverse Events | For phase I - Number of Participants with Treatment Emergent Adverse Events that occur or worsen after the first dose of study treatment. | Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects | Posted | Count of Participants | Participants | 24 weeks |
|
Treatment-related and non-treatment-related adverse events were monitored/assessed up to 33 weeks. Patients who have an on-going study drug-related SAE upon study completion/discontinuation will be contacted by PI/designee until event is resolved/determined to be irreversible, up to 33 weeks.
Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects
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 | Cohort 1: N-803 - IV 1 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandeep Bobby Reddy, Chief Medical Officer | ImmunityBio | 855-797-9277 | Bobby.Reddy@Immunitybio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2015 | Apr 17, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| C582303 | ALT-803 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
time of the observed maximum concentration (Tmax) |
| PK timepoint up to 72 hours +/- 6 hours |
| Characterization of the Pharmacokinetic Profile - Maximum Observed Concentration (Cmax) | maximum observed concentration (Cmax) | PK timepoint up to 72 hours +/- 6 hours |
| Characterization of the Pharmacokinetic Profile - Area Under the Plasma Concentration Curve | Area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t). PK samples were obtained from the start of treatment until 72 hours. The AUC0-168 and AUC0-inf were calculated with noncompartmental pharmacokinetic analysis equations. | Samples were collected and the AUC was determined at 24 hours and at time t (last measurable concentration). The AUC was calculated for 168 hours and time to infinity. |
| Characterization of the Pharmacokinetic Profile - Clearance (CL) | Clearance (CL) | PK timepoint up to 72 hours +/- 6 hours |
| Characterization of the Pharmacokinetic Profile - Vss Volume of Distribution at Steady State | Vss Volume of distribution at steady state is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration | PK timepoint up to 72 hours +/- 6 hours |
| Immunogenicity - Anti-drug Antibody (ADA) | Number of patients with a positive Anti-drug Antibody (ADA) result | From Baseline up to Week 12 |
| Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Clearance (CL/F) | Apparent (Extravascular) Clearance (CL/F) | PK timepoint up to 72 hours +/- 6 hours |
| Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Volume of Distribution (Vz/F) | Apparent volume of distribution is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration | PK timepoint up to 72 hours +/- 6 hours |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Adverse Event |
|
| Physician Decision |
|
ALT-803: Intravenous infusion for cohort 1, 2, 3 and 4; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| BG002 | Cohort 3: ALT-803 - IV 6 ug/kg | ALT-803: Intravenous infusion for cohort 1, 2, 3 and 4; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| BG003 | Cohort 4: ALT-803 - IV 10 ug/kg | ALT-803: Intravenous infusion for cohort 1, 2, 3 and 4; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| BG004 | Cohort 5: ALT-803 - SQ 10 ug/kg | ALT-803: subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| BG005 | Cohort 6: ALT-803 - SQ 15 ug/kg | ALT-803: subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| BG006 | Cohort 7: ALT-803 - SQ 20 ug/kg | ALT-803: subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Patients with Relapsed or Refractory Multiple Myeloma | Count of Participants | Participants |
|
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
| OG002 | Cohort 3: N-803 - IV 6 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| OG003 | Cohort 4: N-803 - IV 10 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| OG004 | Cohort 5: N-803 - SQ 10 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
| OG005 | Cohort 6: N-803 - SQ 15 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles |
|
|
| Primary | Disease Response Rate of Treated Patients | CR- negative SIFE and UIFE, disappearance of any soft tissue plasmacytomas, and < or = to 5% plasma cells in bone marrow VGPR - either + SIFE and UIFE and - SPEP and UPEP or reduction in serum M-protein > or = to 90% and urine m-protein level <100mg per 24h PR - if measurable serum an urine m-protein them reduction of serum m-protein by >=50% and reduction in 24h urinary m protein by >=90% or to <200mg per 24h if unmeasurable serum and urine m-protein then >= 50% decrease in the difference between involve and uninvolved FLC levels If unmeasurable serum and urine m-protein and serum FLC assay then >= 50% reduction in plasma cells, provide baseline bone marrow plasma cell percentage was >=30% In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required PD - defined via International Myeloma Working Group uniform response criteria: disease progression SD - not meeting criteria for CR, VGPR, PR or PD | Cohort 5: N-803 - SQ 10 ug/kg - one subject only received 2 doses of study drug. This subject is not evaluable for tumor response assessment. Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects | Posted | Count of Participants | Participants | Starts at Week 11 - 12 and Week 23 - 24 |
|
|
|
| Secondary | Characterization of the Pharmacokinetic Profile - Half-life (t½) | Half-life (t½) - The period of time required for the concentration or amount of drug in the body to be reduced by one-half. | Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects. In addition, 6 out of 7 SC patients (Cohorts 5 and 6) had insufficient measurable post-tmax sampling to allow for evaluation of the terminal phase-dependent PK parameters (ie, t½, CL/F, Vz/F, AUC0-168, AUC0-∞). | Posted | Mean | Full Range | Hours | PK timepoint up to 72 hours +/- 6 hours |
|
|
|
| Secondary | Characterization of the Pharmacokinetic Profile - Time of the Observed Maximum Concentration (Tmax) | time of the observed maximum concentration (Tmax) | Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects | Posted | Median | Full Range | Hours | PK timepoint up to 72 hours +/- 6 hours |
|
|
|
| Secondary | Characterization of the Pharmacokinetic Profile - Maximum Observed Concentration (Cmax) | maximum observed concentration (Cmax) | Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects | Posted | Mean | Standard Deviation | ng/mL | PK timepoint up to 72 hours +/- 6 hours |
|
|
|
| Secondary | Characterization of the Pharmacokinetic Profile - Area Under the Plasma Concentration Curve | Area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t). PK samples were obtained from the start of treatment until 72 hours. The AUC0-168 and AUC0-inf were calculated with noncompartmental pharmacokinetic analysis equations. | Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects In addition, 6 out of 7 SC patients (Cohorts 5 and 6) had insufficient measurable post-tmax sampling to allow for evaluation of the terminal phase-dependent PK parameters (ie, t½, CL/F, Vz/F, AUC0-168, AUC0-∞). | Posted | Mean | Full Range | hr x ng/mL | Samples were collected and the AUC was determined at 24 hours and at time t (last measurable concentration). The AUC was calculated for 168 hours and time to infinity. |
|
|
|
| Secondary | Characterization of the Pharmacokinetic Profile - Clearance (CL) | Clearance (CL) | Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects Cohorts 1-4 - Clearance (CL) | Posted | Mean | Full Range | mL/hr/kg | PK timepoint up to 72 hours +/- 6 hours |
|
|
|
| Secondary | Characterization of the Pharmacokinetic Profile - Vss Volume of Distribution at Steady State | Vss Volume of distribution at steady state is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration | Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects | Posted | Mean | Full Range | mL/kg | PK timepoint up to 72 hours +/- 6 hours |
|
|
|
| Secondary | Immunogenicity - Anti-drug Antibody (ADA) | Number of patients with a positive Anti-drug Antibody (ADA) result | Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects | Posted | Count of Participants | Participants | From Baseline up to Week 12 |
|
|
|
| Secondary | Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Clearance (CL/F) | Apparent (Extravascular) Clearance (CL/F) | In addition, 6 out of 7 SC patients (Cohorts 5 and 6) had insufficient measurable post-tmax sampling to allow for evaluation of the terminal phase-dependent PK parameters (ie, t½, CL/F, Vz/F, AUC0-168, AUC0-∞). | Posted | Mean | Full Range | mL/hr/kg | PK timepoint up to 72 hours +/- 6 hours |
|
|
|
| Secondary | Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Volume of Distribution (Vz/F) | Apparent volume of distribution is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration | Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects In addition, 6 out of 7 SC patients (Cohorts 5 and 6) had insufficient measurable post-tmax sampling to allow for evaluation of the terminal phase-dependent PK parameters (ie, t½, CL/F, Vz/F, AUC0-168, AUC0-∞). | Posted | Mean | Full Range | mL/kg | PK timepoint up to 72 hours +/- 6 hours |
|
|
|
| 2 |
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | Cohort 2: N-803 - IV 3 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Cohort 3: N-803 - IV 6 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles | 1 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Cohort 4: N-803 - IV 10 ug/kg | N-803: Intravenous infusion for cohort 1, 2, 3 and 4; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles | 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Cohort 5: N-803 - SQ 10 ug/kg | N-803: subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles | 3 | 4 | 3 | 4 | 4 | 4 |
| EG005 | Cohort 6: N-803 - SQ 15 ug/kg | N-803: subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles | 0 | 3 | 0 | 3 | 3 | 3 |
| EG006 | Cohort 7: N-803 - SQ 20 ug/kg | N-803: subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles | 0 | 0 | 0 | 0 | 0 | 0 |
| Pyrexia | General disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ataxia | Nervous system disorders | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Administration site extravasation | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
|
| Injection site reaction | General disorders | Systematic Assessment |
|
| Mass | General disorders | Systematic Assessment |
|
| Oedema | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Gingivitis | Infections and infestations | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | Systematic Assessment |
|
| Lung infection | Infections and infestations | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Haptoglobin increased | Investigations | Systematic Assessment |
|
| International normalised ratio increased | Investigations | Systematic Assessment |
|
| Lymphocyte count decreased | Infections and infestations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperproteinaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Extradural neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Aphasia | Nervous system disorders | Systematic Assessment |
|
| Ataxia | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| Presyncope | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Progressive Disease |
|
| Not available to evaluate |
|
|
| AUC0-24 |
|
|
| AUC0-168 |
|
|
| AUC0-inf |
|
|