FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Fate Therapeutics
Study ID
NCT04245722
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • FT596 — DRUG
    Experimental Interventional Therapy
  • Cyclophosphamide — DRUG
    Lympho-conditioning agent
  • Fludarabine — DRUG
    Lympho-conditioning agent
  • Rituximab — DRUG
    Monoclonal Antibody
  • Obinutuzumab — DRUG
    Monoclonal Antibody
  • Bendamustine — DRUG
    Conditioning agent

Study Details

This is a Phase I dose-finding study of FT596 as monotherapy and in combination with Rituximab or Obinutuzumab in subjects with relapsed/refractory B-cell Lymphoma or Chronic Lymphocytic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

Key Dates

First listed
Jan 29, 2020
Start date
Mar 19, 2020
Status verified
Oct 2023
Primary completion
Sep 27, 2023
Completion
Sep 27, 2023

Study Design

Enrollment
98 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: FT596 Monotherapy, Lymphoma
    FT596 monotherapy in adult subjects with r/r B-cell Lymphoma
  • Experimental: FT596 in Combination with Rituximab, Lymphoma
    FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
  • Experimental: FT596 in Combination with Obinutuzumab, Lymphoma
    FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
  • Experimental: FT596 Monotherapy, CLL
    FT596 monotherapy in adult subjects with r/r CLL
  • Experimental: FT596 in Combination with Obinutuzumab, CLL
    FT596 in combination with Obinutuzumab in adult subjects with r/r CLL

Primary Outcome Measure

Incidence of dose-limiting toxicities within each dose level cohort [ Time Frame: Day 29 ]

Locations (9)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637-
University of Minnesota Masonic Cancer CenterMinneapolisMinnesota55455-
Washington University School of MedicineSt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYU Langone HealthNew YorkNew York10016-
Sarah Cannon Research Institute (Tennessee Oncology)NashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-
SCRI-TTISan AntonioTexas78229-
Swedish Cancer InstituteSeattleWashington98104-

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The University of Chicago· Chicago, ILUniversity of Minnesota Masonic Cancer Center· Minneapolis, MNWashington University School of Medicine· St Louis, MOMemorial Sloan Kettering Cancer Center· New York, NYNYU Langone Health· New York, NYSarah Cannon Research Institute (Tennessee Oncology)· Nashville, TN

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