Clinical trial · Interventional
FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
NCT05934097CI-TRIAL-00067803withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was withdrawn (Sponsor decision).
Summary
Brief summary (as posted)
This is a Phase I study of FT596 in combination with two different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will consist of a dose-escalation stage followed by a dose-expansion stage.
Conditions
Conditions (5)
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 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Transformed Indolent Non-Hodgkin's Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| FT596 | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen A (FT596 in combination with standard schedule R-CHOP)
- description
- FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.
- interventionNames
- Drug: FT596
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Rituximab
- Drug: Bendamustine
- type
- EXPERIMENTAL
- label
- Regimen B (FT596 in combination with alternate schedule R-CHOP)
- description
- FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles
- interventionNames
- Drug: FT596
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Diagnosis of B-cell lymphoma (BCL) as described below: * Histologically documented BCL * Previously untreated or no more than one prior systemic therapy for BCL * At least one bi-dimensionally measurable lesion * Subjects with \>1 measurable lesion agreement to undergo a biopsy * Capable of giving signed informed consent * Age ≥ 18 years old * Stated willingness to comply with study procedures through study duration * Contraception use for women and men as defined in the protocol * Negative serum pregnancy test within 7 days of treatment for women Key Exclusion Criteria: * Prior anthracycline therapy * Females who are pregnant or breastfeeding * Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2 * Evidence of insufficient organ function * Currently receiving or likely to receive systemic immunosuppressive therapy * Receipt of allograft organ transplant * Known active central nervous system (CNS) involvement by malignancy * Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease * Clinically significant cardiovascular disease * Positive HIV test * Positive Hepatitis B (HBV) or Hepatitis C (HCV) test * Live vaccine \<6 weeks prior to start of conditioning * Allergy to human albumin or dimethyl sulfoxide (DMSO)
References
Publications (0)
Data not yet available
No reference posted for this study.