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
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
* 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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