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

Fate Therapeutics

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

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

Interventions

FT596DRUG

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

CyclophosphamideDRUG

750 mg/m\^2 intravenously

DoxorubicinDRUG

50 mg/m\^2 intravenously

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Incidence of dose-limiting toxicities within each dose escalation cohort

Time frame: Day 21

Nature of dose-limiting toxicities within each dose escalation cohort

Time frame: Day 21

Incidence, nature, and severity of adverse events (AEs) of FT596 in combination with R-CHOP in B-cell lymphoma previously untreated or no more than one previous line of therapy with severity determined according to NCI CTCAE, v5.0

Time frame: Up to 5 years

Secondary Outcomes

Investigator-assessed complete response (CR)

Proportion of subjects who achieve a complete response (CR) per Lugano 2014 classification

Time frame: Up to 2 years

Investigator-assessed objective-response rate (ORR)

Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification

Time frame: Up to 2 years

Investigator-assessed duration of response (DOR)

Duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification

Time frame: Up to 15 years

Investigator-assessed duration of complete response (DoCR)

Duration from the first occurrence of a documented complete response (CR), per Lugano 2014 classification until the time of disease progression or relapse, or death from any cause, whichever occurs first

Time frame: Up to 15 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.