Overview

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.

Principal investigator

Umar Farooq
Internal Medicine

Eligibility 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 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
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For Referring Providers

Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.

Contact the study coordinator

Mariel Mimi McKay
Not currently recruiting, contact if interested.