About this trial
This is a phase 1, open-label study to evaluate the safety and efficacy of CD19 t-haNK in patients with B-cell acute lymphoblastic leukemia. Up to 10 patients will receive at least 1 dose of study drug.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 12 years old.
Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines.
Histologically or flow cytometry documented pre B-ALL.
Relapsed after achieving a 2nd complete remission (CR) or failed one cycle of re-induction therapy or with MRD positivity after ≥ 2 cycles of induction.
Disqualifiers
Participants with T-cell leukaemia and Burkitt's M3 leukaemia.
Known hypersensitivity or allergy to any component of the study medication(s), including sulfa-containing (eg, dimethyl sulfoxide, DMSO).
Serum creatinine ≥ 2 mg/dL
Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≥ 5 upper limit of normal (ULN)
Trial design
Single group
Treatments tested in this trial
CD19 t-haNK
DrugIV infusion of CD19 t-haNK
Treatment groups
Trial outcomes
Primary outcomes
Evaluate safety of CD19 t-haNK as a single agent in participants with selected CD19+ relapsed B-ALL.
Incidence of TEAEs and SAEs graded using the NCI CTCAE Version 5.0 and clinically important changes in safety laboratory tests and vital signs.
Secondary outcomes
Obtain preliminary estimates of efficacy of CD19 t-haNK in terms of bone marrow response.
Bone marrow aspirate will be performed for bone marrow analysis on Day 22 (±3 days), and every 8 weeks (±1 week) thereafter.
Obtain preliminary estimates of efficacy of CD19 t-haNK in terms of overall survival (OS)
OS will be evaluated using Kaplan-Meier methods. OS will be defined as the time from the date of first treatment to the date of death (any cause).
Sponsors and contacts
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