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

NCT05934097 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: FT596-102
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Incidence of dose-limiting toxicities within each dose escalation cohort

  Day 21

• Nature of dose-limiting toxicities within each dose escalation cohort

  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

  Up to 5 years

Secondary Outcomes (8)

• Investigator-assessed complete response (CR)

  Up to 2 years

• Investigator-assessed objective-response rate (ORR)

  Up to 2 years

• Investigator-assessed duration of response (DOR)

  Up to 15 years

• Investigator-assessed duration of complete response (DoCR)

  Up to 15 years

• Progression-free survival (PFS)

  Up to 15 years

Study Arms (2)

Regimen A (FT596 in combination with standard schedule R-CHOP)

EXPERIMENTAL

FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.

Drug: FT596; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Rituximab; Drug: Bendamustine

Regimen B (FT596 in combination with alternate schedule R-CHOP)

EXPERIMENTAL

FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles

Drug: FT596; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Rituximab; Drug: Bendamustine

Interventions

FT596 DRUG

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

Regimen A (FT596 in combination with standard schedule R-CHOP); Regimen B (FT596 in combination with alternate schedule R-CHOP)

Cyclophosphamide DRUG

750 mg/m\^2 intravenously

Regimen A (FT596 in combination with standard schedule R-CHOP); Regimen B (FT596 in combination with alternate schedule R-CHOP)

Doxorubicin DRUG

50 mg/m\^2 intravenously

Regimen A (FT596 in combination with standard schedule R-CHOP); Regimen B (FT596 in combination with alternate schedule R-CHOP)

Vincristine DRUG

1.4 mg/m\^2 (maximum dose 2 mg) intravenously

Regimen A (FT596 in combination with standard schedule R-CHOP); Regimen B (FT596 in combination with alternate schedule R-CHOP)

Prednisone DRUG

100 mg orally

Regimen A (FT596 in combination with standard schedule R-CHOP); Regimen B (FT596 in combination with alternate schedule R-CHOP)

Rituximab DRUG

375 mg/m\^2 intravenously

Also known as: Rituxan, Truxima, Ruxience

Regimen A (FT596 in combination with standard schedule R-CHOP); Regimen B (FT596 in combination with alternate schedule R-CHOP)

Bendamustine DRUG

90 mg/m\^2 IV infusion

Also known as: Bendeka, Treanda

Regimen A (FT596 in combination with standard schedule R-CHOP); Regimen B (FT596 in combination with alternate schedule R-CHOP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fate Therapeutics: lead

MeSH Terms

Conditions

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

Interventions

Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Rituximab; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles

Study Officials

• Fate Trial Disclosure

  Fate Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be assigned to one of 2 treatment regimens corresponding to different schedules (standard or alternate) of R-CHOP

Study Record Dates

• First Submitted: April 30, 2023
• First Posted: July 6, 2023
• Study Start: December 1, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2039
• Last Updated: July 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share