Chronic Lymphocytic Leukemia, Lymphoma, B-Cell, Precursor B-Cell Acute Lymphoblastic Leukemia
Conditions
Keywords
Lymphoma, Leukemia, BCL, CLL, B-ALL, CAR-T, cellular therapy
Brief 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.
Interventions
DRUGFT819
Experimental Interventional Therapy
DRUGCyclophosphamide
Lympho-conditioning agent
DRUGFludarabine
Lympho-conditioning agent
DRUGIL-2
Biologic response modifier
DRUGBendamustine
Lympho-conditioning agent
Sponsors
Fate Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and nature of dose-limiting toxicities within each dose level cohort | Up to Day 29 |
| Incidence, nature, and severity of adverse events (AEs) of FT819 as monotherapy and in combination with IL-2 in r/r B-cell lymphoma, r/r chronic lymphocytic leukemia, and r/r precursor B-cell acute lymphoblastic leukemia | Up to 15 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed objective-response rate (ORR) | Up to approximately 2 years after last dose of FT819 | — |
| For BCL and CLL Only: Investigator-assessed duration of objective response (DOR) | Up to 15 years | — |
| For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR) | Up to 15 years | — |
| For BCL and CLL Only: Progression-free survival (PFS) | Up to 15 years | — |
| Overall survival (OS) | Up to 15 years | — |
| Determination of the pharmacokinetics of FT819 cells in peripheral blood. | Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29 | The PK of FT819 in peripheral blood will be reported as the relative percentage of product (FT819) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points |
| For B-ALL Only: Investigator-assessed relapse-free survival (RFS) | Up to 15 years | — |
Countries
United States
Contacts
STUDY_DIRECTORFate Trial Disclosure
Fate Therapeutics
Outcome results
None listed