OncoMatch/Clinical Trials/NCT06580301
Study of YK012 in B-cell Acute Lymphoblastic Leukemia
Is NCT06580301 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies YK012 for b-cell acute lymphoblastic leukemia.
Treatment: YK012 — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 overexpression (positive)
A definitive diagnosis of CD19-positive B-cell acute lymphoblastic leukemia
Excluded: BCR fusion
Burkitt´s Leukemia according to World Health Organization (WHO) classification [excluded]
Excluded: ABL1 fusion
Burkitt´s Leukemia according to World Health Organization (WHO) classification [excluded]
Excluded: CD19 targeted therapy
History of CD19 targeted therapy and positive test result for immunogenicity of YK012 at screening
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: targeted therapy (small molecule)
Exception: within 2 weeks or 5 half-lives, whichever is longer
Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer
Cannot have received: targeted therapy (macromolecular)
Exception: within 3 weeks
Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 3 weeks
Cannot have received: radiotherapy or chemotherapy
Exception: within 2 weeks (except for intrathecal chemotherapy and dexamethasone)
Radiotherapy or chemotherapy (except for intrathecal chemotherapy and dexamethasone), or treatment with Chinese traditional/patent medicine that has definite antitumor effect within 2 weeks
Cannot have received: investigational drug
Exception: within 4 weeks or 5 half-lives, whichever is shorter
Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter
Cannot have received: live attenuated vaccines or live virus vaccine
Exception: within 4 weeks
Receipt of any live attenuated vaccines or live virus vaccine within 4 weeks
Cannot have received: autologous stem cell transplantation
Exception: within 6 weeks
Autologous stem cell transplantation within 6 weeks
Cannot have received: allogeneic stem cell transplantation
Exception: within 12 weeks
allogeneic stem cell transplantation within 12 weeks
Cannot have received: organ transplant
History of organ transplant
Cannot have received: CD19 targeted therapy
History of CD19 targeted therapy and positive test result for immunogenicity of YK012 at screening
Lab requirements
Blood counts
Adequate hematological function; ≥ 5% blasts in the bone marrow by morphologic assessment
Kidney function
Adequate organ function
Liver function
Adequate organ function
Cardiac function
No history or evidence of cardiovascular disease as defined in exclusion criteria
Adequate hematological and organ function. ≥ 5% blasts in the bone marrow by morphologic assessment. See exclusion criteria for cardiac function requirements.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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