FT819 in Subjects With B-cell Malignancies

• Status: Recruiting
• Trial end date: 2039-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I dose-finding study of FT819 as monotherapy and in combination with IL-2 in subjects with relapsed/refractory B-cell Lymphoma, Chronic Lymphocytic Leukemia and Precursor B-cell Acute Lymphoblastic 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: Cyclophosphamide; Fludarabine; Interleukin-2

Criteria

Key Inclusion Criteria:

Diagnosis of B-cell lymphoma, CLL or B-ALL as described below:

B-Cell Lymphoma:

• Histologically documented lymphomas expected to express CD19

• Relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy

Chronic Lymphocytic Leukemia (CLL):

• Diagnosis of CLL per iwCLL guidelines

• Relapsed/refractory disease following at least two prior systemic treatment regimens

Precursor B-cell Acute Lymphocytic Leukemia (B-ALL):

• Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics

• Relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing 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

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 of 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

• Ongoing requirement for systemic GvHD therapy following prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T

• 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

• Positive serologic test results for HIV infection

• Positive serologic or polymerase chain reaction (PCR) test results for Hepatitis B (HBV) infection

• Positive serologic and PCR test results for Hepatitis C (HCV) infection

• Live vaccine <6 weeks prior to start of lympho-conditioning

• Known allergy to albumin (human) or DMSO