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

Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05934097
• Other study ID #: FT596-102
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 2022
• Est. completion date: May 2039

Study information

• Verified date: June 2023
• Source: Fate Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2039
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Follicular Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma

Intervention

Drug:
• FT596
Dosing to be initiated at a dose no higher than highest tolerable dose in study FT596-101, intravenously
• Cyclophosphamide
750 mg/m^2 intravenously
• Doxorubicin
50 mg/m^2 intravenously
• Vincristine
1.4 mg/m^2 (maximum dose 2 mg) intravenously
• Prednisone
100 mg orally
• Rituximab
375 mg/m^2 intravenously
• Bendamustine
90 mg/m^2 IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fate Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicities within each dose escalation cohort		Day 21
Primary	Nature of dose-limiting toxicities within each dose escalation cohort		Day 21
Primary	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		Up to 5 years
Secondary	Investigator-assessed complete response (CR)	Proportion of subjects who achieve a complete response (CR) per Lugano 2014 classification	Up to 2 years
Secondary	Investigator-assessed objective-response rate (ORR)	Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification	Up to 2 years
Secondary	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	Up to 15 years
Secondary	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	Up to 15 years
Secondary	Progression-free survival (PFS)	Time from first dose of study treatment to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification	Up to 15 years
Secondary	Overall survival (OS)	Time from first dose of study treatment to death from any cause	Up to 15 years
Secondary	Area Under the Plasma Concentration Time Curve (AUC) of FT596	Assessed by the detection of FT596 in peripheral blood following FT596 administration.	Cycles 1-6 (each cycle is 28 days): Days 1,8,11,15,18; and Post-Treatment Week 1, Week 2, Week 4, and Week 8
Secondary	Maximum Plasma Concentration (Cmax) of FT596	Assessed by the detection of FT596 in peripheral blood following FT596 administration.	Cycles 1-6 (each cycle is 28 days): Days 1,8,11,15,18; and Post-Treatment Week 1, Week 2, Week 4, and Week 8