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

Sponsor
Fate Therapeutics
Study ID
NCT05934097
Phase
PHASE1
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 31, 2022
Status verified
Jun 2023
Primary completion
May 31, 2026
Completion
May 31, 2039

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A (FT596 in combination with standard schedule R-CHOP)
    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.
  • Experimental: Regimen B (FT596 in combination with alternate schedule R-CHOP)
    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

Primary Outcome Measure

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

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