Study of YK012 in B-cell Acute Lymphoblastic Leukemia
ConditionB-cell Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorExcyte Biopharma Ltd
About this trial
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
Qualifiers
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.
Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
An estimated survival time of more than 12 weeks.
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).
Disqualifiers
Burkitt´s Leukemia according to World Health Organization (WHO) classification.
Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer
Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 3 weeks
Radiotherapy or chemotherapy (except for intrathecal chemotherapy and dexamethasone), or treatment with Chinese traditional/patent medicine that has definite antitumor effect within 2 weeks
Trial design
Treatments tested in this trial
- YK012
Treatment groups
46 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov