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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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Recruitment status: Withdrawn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
Countries of recruitment
Contacts
Name:     Fate Trial Disclosure
Address: 
Telephone:
Email:
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
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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