FT819 in Subjects With B-cell Malignancies

Trial ID or NCT#

NCT04629729

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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:
  1. 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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Investigator(s)

David Miklos
David Miklos
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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Contact

Maria Iglesias
+1 650-723-4247

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View on ClinicalTrials.gov