TriangleNCT04074746 · OUTCOME
Maximum Tolerate Dose of AFM13 Umbilical Cord Blood(UCB) Derived Natural Killer(NK) Cells Infused on D=0,D+7,D+14,D+21 for Each Cohort (1x10^6,1x10^7,1x10^8).
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 28 days post AFM13-NK cells on D=0 for each Cohort.
What was measured
Number of Participants who have experienced Dose-limiting toxicity (DLT) during AFM13-NK cell infusions. DLT will be defined as any related grade 3 or greater non- hematologic toxicity that occurs within 28 days of AFM13-NK infusion
Groups in this outcome
Phase I_ Cohort 1(1x10^6/kg)
Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
Phase I_ Cohort 2(1x10^7/kg)
Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
Phase I_ Cohort 3(1x10^8/kg)
Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
Phase II_ Cohort 3(1x10^8/kg)
Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
| Group | Source count |
|---|---|
| Phase I_ Cohort 1(1x10^6/kg) | 3 |
| Phase I_ Cohort 2(1x10^7/kg) | 3 |
| Phase I_ Cohort 3(1x10^8/kg) | 4 |
| Phase II_ Cohort 3(1x10^8/kg) | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I_ Cohort 1(1x10^6/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I_ Cohort 2(1x10^7/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I_ Cohort 3(1x10^8/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase II_ Cohort 3(1x10^8/kg) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 35
- units
- Participants
- description
- Number of Participants who have experienced Dose-limiting toxicity (DLT) during AFM13-NK cell infusions. DLT will be defined as any related grade 3 or greater non- hematologic toxicity that occurs within 28 days of AFM13-NK infusion
- groups
- description
- Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
- id
- OG000
- title
- Phase I_ Cohort 1(1x10^6/kg)
- description
- Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
- id
- OG001
- title
- Phase I_ Cohort 2(1x10^7/kg)
- description
- Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
- id
- OG002
- title
- Phase I_ Cohort 3(1x10^8/kg)
- description
- Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
- id
- OG003
- title
- Phase II_ Cohort 3(1x10^8/kg)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 28 days post AFM13-NK cells on D=0 for each Cohort.
- title
- Maximum Tolerate Dose of AFM13 Umbilical Cord Blood(UCB) Derived Natural Killer(NK) Cells Infused on D=0,D+7,D+14,D+21 for Each Cohort (1x10^6,1x10^7,1x10^8).
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice