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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 July 2023
• Main ID: NCT05934097
• Date of registration: 30/04/2023
• Prospective Registration: No
• Primary sponsor: Fate Therapeutics
• Public title: FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
• Scientific title: A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
• Date of first enrolment: December 2022
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT05934097
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Contacts

• Name: Fate Trial Disclosure
• Affiliation: Fate Therapeutics

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diffuse Large B Cell Lymphoma

Transformed Indolent Non-Hodgkin's Lymphoma

Mantle Cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Intervention(s)

Drug: Rituximab

Drug: Bendamustine

Drug: Cyclophosphamide

Drug: Prednisone

Drug: Doxorubicin

Drug: Vincristine

Drug: FT596

Primary Outcome(s)

Incidence 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]

Nature of dose-limiting toxicities within each dose escalation cohort [Time Frame: Day 21]

Secondary Outcome(s)

Progression-free survival (PFS) [Time Frame: Up to 15 years]

Investigator-assessed objective-response rate (ORR) [Time Frame: Up to 2 years]

Maximum Plasma Concentration (Cmax) of FT596 [Time Frame: 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]

Overall survival (OS) [Time Frame: Up to 15 years]

Investigator-assessed complete response (CR) [Time Frame: Up to 2 years]

Investigator-assessed duration of complete response (DoCR) [Time Frame: Up to 15 years]

Investigator-assessed duration of response (DOR) [Time Frame: Up to 15 years]

Area Under the Plasma Concentration Time Curve (AUC) of FT596 [Time Frame: 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 ID(s)

FT596-102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors