FT819 in Subjects With B-cell Malignancies
a study on Lymphoma Chronic Lymphocytic Leukemia Leukemia Acute Lymphoblastic Leukemia B-Cell Acute Lymphoblastic Leukemia
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis UCLA
- Dates
- study startedcompletion around
Description
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.
Official Title
A Phase I Study of FT819 in Subjects With B-cell Malignancies
Keywords
Lymphoma, B-Cell, Chronic Lymphocytic Leukemia, Precursor B-Cell Acute Lymphoblastic Leukemia, Lymphoma, Leukemia, BCL, CLL, B-ALL, CAR-T, cellular therapy, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, B-Cell Lymphoma, Cyclophosphamide, Bendamustine Hydrochloride, Fludarabine, Interleukin-2, Bendamustine, FT819 Step Fractionated Monotherapy, B-Cell Lymphoma, FT819 Step Fractionated Monotherapy, CLL, FT819 Step Fractionated Monotherapy, B-ALL
Eligibility
You can join if…
Open to people ages 18 years and up
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
You CAN'T join if...
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
Locations
- UC Davis
accepting new patients
Davis California 95817 United States - UCLA Ronald Reagan Medical Center
accepting new patients
Los Angeles California 90095 United States - Stanford Cancer Institute
accepting new patients
Palo Alto California 94304 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Fate Therapeutics
- Links
- ASH 2022 Poster Presentation ASH 2022 Abstract
- ID
- NCT04629729
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 396 study participants
- Last Updated