FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

NCT ID: NCT05934097

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2039-05-31

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.

Conditions

Diffuse Large B Cell Lymphoma; Transformed Indolent Non-Hodgkin's Lymphoma; Follicular Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

FT596

Intervention Type: DRUG

Dosing to be initiated at a dose no higher than highest tolerable dose in study FT596-101, intravenously

Cyclophosphamide

Intervention Type: DRUG

750 mg/m\^2 intravenously

Doxorubicin

Intervention Type: DRUG

50 mg/m\^2 intravenously

Vincristine

Intervention Type: DRUG

1.4 mg/m\^2 (maximum dose 2 mg) intravenously

Prednisone

Intervention Type: DRUG

100 mg orally

Rituximab

Intervention Type: DRUG

375 mg/m\^2 intravenously

Bendamustine

Intervention Type: DRUG

90 mg/m\^2 IV infusion

Regimen B (FT596 in combination with alternate schedule R-CHOP)

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

Group Type: EXPERIMENTAL

FT596

Intervention Type: DRUG

Dosing to be initiated at a dose no higher than highest tolerable dose in study FT596-101, intravenously

Cyclophosphamide

Intervention Type: DRUG

750 mg/m\^2 intravenously

Doxorubicin

Intervention Type: DRUG

50 mg/m\^2 intravenously

Vincristine

Intervention Type: DRUG

1.4 mg/m\^2 (maximum dose 2 mg) intravenously

Prednisone

Intervention Type: DRUG

100 mg orally

Rituximab

Intervention Type: DRUG

375 mg/m\^2 intravenously

Bendamustine

Intervention Type: DRUG

90 mg/m\^2 IV infusion

Interventions

FT596

Dosing to be initiated at a dose no higher than highest tolerable dose in study FT596-101, intravenously

Intervention Type: DRUG

Cyclophosphamide

750 mg/m\^2 intravenously

Intervention Type: DRUG

Doxorubicin

50 mg/m\^2 intravenously

Intervention Type: DRUG

Vincristine

1.4 mg/m\^2 (maximum dose 2 mg) intravenously

Intervention Type: DRUG

Prednisone

100 mg orally

Intervention Type: DRUG

Rituximab

375 mg/m\^2 intravenously

Intervention Type: DRUG

Bendamustine

90 mg/m\^2 IV infusion

Intervention Type: DRUG

Other Intervention Names

Rituxan; Truxima; Ruxience; Bendeka; Treanda

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fate Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fate Trial Disclosure

Role: STUDY_DIRECTOR

Fate Therapeutics

Other Identifiers

FT596-102

Identifier Type: -

Identifier Source: org_study_id