Clinical trial · Interventional
FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL
FATE FT596 With Rituximab as Relapse Prevention in High Risk Patients After Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin Lymphoma
NCT04555811CI-TRIAL-00078672completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| High-grade B-cell Lymphoma | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| NHL | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FT596 | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- FT596 + Rituximab Dose Level 1: 9x10^7 cells/dose
- description
- Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10\^7 cells/dose, Dose Level 2: 3x10\^8 cells/dose, Dose Level 3: 9x10\^8 cells/dose with a Dose Level -1: 3x10\^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).
- interventionNames
- Drug: FT596
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- FT596 + Rituximab Dose Level 2: 3x10^8 cells/dose
- description
- Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10\^7 cells/dose, Dose Level 2: 3x10\^8 cells/dose, Dose Level 3: 9x10\^8 cells/dose with a Dose Level -1: 3x10\^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \< 12 months * Lack of complete metabolic (PET scan) response after 2-3 cycles of salvage chemotherapy * Evidence of c-myc and bcl-2 and/or bcl-6 re-arrangement (double hit or triple hit lymphoma) * Age-adjusted IPI 2-3 at relapse * Age 18 years or older at the time of signing consent. * Agrees to use adequate contraception (or evidence of sterility) for at least 12 months after the last dose of rituximab. * Agrees and signs the separate consent for up to 15 years of follow-up (Long-term Follow-up study CPRC#2020LS052) * Provides voluntary written consent prior to the performance of any research related activities. Exclusion Criteria: * Receipt of any investigational therapy within 28 days prior to the first dose of FT596 or planned use of an investigational therapy during the first 100 days after transplant * Planned post-transplant irradiation prior to Day +100 * Seropositive for HIV, active Hepatitis B or C infection with detectable viral load by PCR * Body weight \<50kg * Known allergy to the following FT596 components: albumin (human) or DMSO * Unable to receive rituximab Post-HSCT Reconfirmation of eligibility * No life-threatening medical issues (i.e. ongoing Grade 4 adverse events) where, in the opinion of the treating investigator, use of FT596 is not in the patient's best interest. * No active uncontrolled infection. * Adequate organ function post-transplant including: * alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x ULN (Grade 2 CTCAE v5) * total bilirubin ≤1.5 x ULN (Grade 1 CTCAE v5) * serum creatinine ≤1.5 x ULN (Grade 1 CTCAE v5) * oxygen saturation ≥93% on room air * For Day 30 dosing only - CBC requirement consistent with engraftment (ANC\>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.
References
Publications (0)
Data not yet available
No reference posted for this study.