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FT819 in Subjects With B-cell Malignancies
Recruiting
I'm InterestedTrial ID: NCT04629729
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
Stanford Investigator(s)
David Miklos
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
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
Intervention(s):
drug: FT819
drug: Cyclophosphamide
drug: Fludarabine
drug: IL-2
drug: Bendamustine
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maria Iglesias
+1 650-723-4247