Study of YK012 in B-cell Acute Lymphoblastic Leukemia
Trial Parameters
Brief Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YK012 administered as monotherapy in participants with B-cell acute lymphoblastic leukemia (B-ALL).
Eligibility Criteria
Inclusion Criteria: 1. Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study. 2. Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2. 3. An estimated survival time of more than 12 weeks. 4. A definitive diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with any of the following conditions: 1. Ph-negative B-ALL with any of the following: i. Failure to achieve complete remission after initial induction therapy. ii. Failure to achieve complete remission after salvage treatment. iii. Relapse with first remission duration ≤12 months. iv. Second or later relapse. v. Relapse after hematopoietic stem cell transplantation (HSCT). 2. Ph-positive B-ALL: failure to 1 or more tyrosine kinase inhibitors (TKIs), or intolerance to treatment with TKIs, or with the T315I mutation. 5. ≥ 5% blasts in the bone marrow by