TriangleNCT04074746 · OUTCOME
Number of Participants That Achieved Complete Response (CR) Post AFM13-NK Cell Infusions.
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
- Time Frame: 1 year post AFM13-NK cells on D=0
What was measured
Complete Remission requires all of the following: Complete metabolic response by PET-CT: Score 1-3. Score 1 (no uptake above the background), Score 2 (uptake is less than or equal to the mediastinal blood pool), or Score 3 (uptake is greater than the mediastinal blood pool but less than or equal to the normal liver) with or without a residual mass on 5 point scale or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in Di. Lyric Response Criteria (Appendix 2): Complete Response (CR): PET-CT Scores 1-3 Partial Response (PR): PET-CT Scores 4-5 with reduced uptake compared with baseline. Progression Disease (PD): PET-CT Scores 4-5 with an increased uptake compared to baseline or new and/or regrowth of measurable lesions.
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) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I_ Cohort 2(1x10^7/kg) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I_ Cohort 3(1x10^8/kg) | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase II_ Cohort 3(1x10^8/kg) | 23 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 23
- 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
- Complete Remission requires all of the following: Complete metabolic response by PET-CT: Score 1-3. Score 1 (no uptake above the background), Score 2 (uptake is less than or equal to the mediastinal blood pool), or Score 3 (uptake is greater than the mediastinal blood pool but less than or equal to the normal liver) with or without a residual mass on 5 point scale or on CT, target nodes/nodal masses must regress to ≤ 1.5 cm in Di. Lyric Response Criteria (Appendix 2): Complete Response (CR): PET-CT Scores 1-3 Partial Response (PR): PET-CT Scores 4-5 with reduced uptake compared with baseline. Progression Disease (PD): PET-CT Scores 4-5 with an increased uptake compared to baseline or new and/or regrowth of measurable lesions.
- 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
- Time Frame: 1 year post AFM13-NK cells on D=0
- title
- Number of Participants That Achieved Complete Response (CR) Post AFM13-NK Cell Infusions.
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice