Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a Phase Ib/II study to evaluate the safety and efficacy of autologous T cells
engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with
relapsed or refractory B cell acute lymphoblastic leukemia (ALL).
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Leukemia
Enrollment Eligibility
Inclusion Criteria:
- Age 18 years or older Age 18 years or older
- ECOG performance status of 0 or 1
- Relapsed or refractory B cell ALL
- Patients with Ph+ ALL are eligible if intolerant to TKI, failed two lines of any TKI,
or failed one line of second-generation TKI, or if TKI is contraindicated
- Documented CD19 positivity within 1 month of screening
- Phase Ib: Primary Cohort IA: Presence of ≥5% blasts in BM at screening
- Phase Ib: Exploratory Cohort IB: MRD-positive defined as ≥ 1E-4 and <5% blasts in the
BM at screening
- Phase II: Primary Cohort IIA: Presence of ≥5% blasts in BM at screening
- Phase II: Cohort IIB: ≥2nd CR or CRi with MRD-positive defined as ≥1E-3 by central
ClonoSEQ® NGS testing and <5% blasts in the BM at screening
- Adequate renal, hepatic, pulmonary, and cardiac function
Exclusion Criteria:
- Phase Ib (Cohort IA and Cohort IB) and Phase II (Cohort IIA and Cohort IIB) B-ALL with
isolated EM disease
- Diagnosis of Burkitt's leukaemia/lymphoma or CML lymphoid in blast crisis
- History or presence of clinically relevant CNS pathology
- Presence of CNS-3 disease or CNS-2 disease with neurological changes
- Presence of active or uncontrolled fungal, bacterial, viral, or other infection
requiring systemic antimicrobials for management
- Active or latent Hepatitis B virus or active Hepatitis C virus
- Human Immunodeficiency Virus (HIV), HTLV-1, HTLV-2, syphilis positive test
- Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced
Grade 3 or higher neurotoxicity following blinatumomab.