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

• Status: Recruiting
• Trial end date: 2039-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fate Therapeutics
• Treatments: Antibodies; Antibodies, Monoclonal; Cyclophosphamide; Fludarabine; Obinutuzumab; Rituximab

Criteria

Key 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 two prior systemic treatment regimens

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

Key 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

• 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