A Phase I Study of FT819 in Subjects With B-cell Malignancies

Description

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.

Trial Eligibility

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 and 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

Study Info

Interventions

Locations Recruiting

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