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

  • STATUS
    Recruiting
  • End date
    Apr 28, 2037
  • participants needed
    123
  • sponsor
    Fate Therapeutics
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Updated on 19 February 2024
See if I qualify
treatment regimen
monoclonal antibodies
cyclophosphamide
chronic lymphocytic leukemia
rituximab
lymphoid leukemia
fludarabine
lymphoma
leukemia
monoclonal protein
b-cell lymphoma
lymphocytic leukemia
antibody therapy
contraceptive use
obinutuzumab
refractory b-cell non-hodgkin lymphoma
immunochemotherapy
b-cell lymphoma refractory
rituximab fludarabine

Summary

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.

Details
Condition Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, B-Cell Lymphoma
Age 18years - 100years
Treatment Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab, FT596
Clinical Study IdentifierNCT04245722
SponsorFate Therapeutics
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Diagnosis of B-cell lymphoma or CLL as described below
B-Cell Lymphoma
Histologically documented lymphomas expected to express CD19 and CD20
Relapsed/refractory disease following prior systemic immunochemotherapy regimen
Chronic Lymphocytic Leukemia (CLL)
Diagnosis of CLL per iwCLL guidelines
Relapsed/refractory disease following at least one prior systemic treatment regimen
ALL SUBJECTS
Capable of giving signed informed consent
Age 18 years old
Stated willingness to comply with study procedures and duration
Contraceptive use for women and men as defined in the protocol

Exclusion Criteria

ALL SUBJECTS
Females who are pregnant or breastfeeding
Eastern Cooperative Oncology Group (ECOG) Performance Status 2
Body weight <50 kg
Evidence of insufficient organ function
Receipt therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1
Currently receiving or likely to require systemic immunosuppressive therapy
Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy
Prior treatment with CD19 CAR-T therapy unless documented preservation of CD19 antigen is provided
Receipt of an 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
Known HIV infection
Known active Hepatitis B (HBV) or Hepatitis C (HCV) infection
Live vaccine <6 weeks prior to start of lympho-conditioning
Known allergy to albumin (human) or DMSO
Clear my responses
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treatment regimen
monoclonal antibodies
cyclophosphamide
chronic lymphocytic leukemia
rituximab
lymphoid leukemia
fludarabine
lymphoma
leukemia
monoclonal protein
b-cell lymphoma
lymphocytic leukemia
antibody therapy
contraceptive use
obinutuzumab
refractory b-cell non-hodgkin lymphoma
immunochemotherapy
b-cell lymphoma refractory
rituximab fludarabine

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