Phase 1
Completed N=7
FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL
Source: ClinicalTrials.gov NCT04555811 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Number of Participants Experiencing Dose Limiting Toxicity Events — 0; 0; 0 Participants
Summary
This is a Phase I multi-center study to evaluate the safety of FT596 when given with rituximab as relapse prevention in patients who have undergone an autologous hematopoietic stem cell transplant (auto-HSCT) for diffuse large or high-grade B cell lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Dose Limiting Toxicity Events |
0; 0; 0 | — |
| SECONDARY Number of Participants Experiencing Adverse Events |
3; 0; 1 | — |
| SECONDARY Percentage of Participants With Relapse/Progression |
67; 33; 0 | — |
| SECONDARY Number of Participants Experiencing Non-relapse Mortality Incidents at 100 Days Post HSCT |
0; 0; 0 | — |
| SECONDARY Percentage of Non-relapse Mortality Incidents at One Year Post HSCT |
67; 100; 100 | — |
| SECONDARY Progression-Free Survival 12 Months Post Auto-HCT |
33; 67; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of diffuse large B cell lymphoma or aggressive (high-grade) B-cell lymphoma for which an autologous stem cell transplant is planned or recently completed
- High risk for relapse defined as at least one of the below:
- Primary induction failure (no complete or partial remission at any point after diagnosis
- Initial remission duration 500, platelet>20,000 without transfusion support within previous 7 days). There are no CBC parameters for Day 7 dosing.
- No requirement for systemic immunosuppressive therapy (> 5mg prednisone daily) during the FT596 dosing period.
Data sourced from ClinicalTrials.gov (NCT04555811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.