A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

Fate Therapeutics0 sitesStarted: December 2022Last updated: July 6, 2023

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Withdrawn
Sponsor: Fate Therapeutics
Primary Endpoint: Nature of dose-limiting toxicities within each dose escalation cohort

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

Detailed Description

This is a Phase I study of FT596 in combination with 2 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 evaluate both the clinical benefit of FT596 when combined with R-CHOP given on a standard or alternate schedule.

Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. After safety and tolerability have been assessed to define the maximum tolerated dose (MTD) (or the maximum assessed dose [MAD] in the absence of dose limiting toxicities [DLTs] defining the MTD) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of FT596 in combination.

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

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)

Arms & Interventions

Regimen A (FT596 in combination with standard schedule R-CHOP)

Experimental

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.

Intervention: FT596 (Drug)

Regimen A (FT596 in combination with standard schedule R-CHOP)

Experimental

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.

Intervention: Cyclophosphamide (Drug)

Regimen A (FT596 in combination with standard schedule R-CHOP)

Experimental

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.

Intervention: Doxorubicin (Drug)

Regimen A (FT596 in combination with standard schedule R-CHOP)

Experimental

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.

Intervention: Vincristine (Drug)

Regimen A (FT596 in combination with standard schedule R-CHOP)

Experimental

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.

Intervention: Prednisone (Drug)

Regimen A (FT596 in combination with standard schedule R-CHOP)

Experimental

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.

Intervention: Rituximab (Drug)

Regimen A (FT596 in combination with standard schedule R-CHOP)

Experimental

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.

Intervention: Bendamustine (Drug)