Clinical trial NCT05934097: FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
Official title: A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Diffuse Large B Cell Lymphoma
Transformed Indolent Non-Hodgkin's Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Marginal Zone Lymphoma
Lead sponsor: Fate Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be assigned to one of 2 treatment regimens corresponding to different schedules (standard or alternate) of R-CHOP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of dose-limiting toxicities within each dose escalation cohort
timeFrame: Day 21
measure: Nature of dose-limiting toxicities within each dose escalation cohort
timeFrame: Day 21
measure: 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
timeFrame: Up to 5 years
Secondary outcomes:
measure: Investigator-assessed complete response (CR)
timeFrame: Up to 2 years
measure: Investigator-assessed objective-response rate (ORR)
timeFrame: Up to 2 years
measure: Investigator-assessed duration of response (DOR)
timeFrame: Up to 15 years
measure: Investigator-assessed duration of complete response (DoCR)
timeFrame: Up to 15 years
measure: Progression-free survival (PFS)
timeFrame: Up to 15 years
measure: Overall survival (OS)
timeFrame: Up to 15 years
measure: Area Under the Plasma Concentration Time Curve (AUC) of FT596
timeFrame: 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
measure: Maximum Plasma Concentration (Cmax) of FT596
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Fate Therapeutics
name: Fate Trial Disclosure
role: STUDY_DIRECTOR
References: