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
Qualifiers
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
Treatments tested in this trial
- CD19 t-haNK