OncoMatch/Clinical Trials/NCT04260022
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
Is NCT04260022 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Ascentage Pharma HQP1351 bioavailable inhibitor and Blinatumomab for leukemia, myeloid, chronic.
Treatment: Ascentage Pharma HQP1351 bioavailable inhibitor · Blinatumomab — A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: BCR fusion
Ph+ (Philadelphia chromosome positive)
Required: ABL1 fusion
Ph+ (Philadelphia chromosome positive)
Allowed: ABL1 T315I
with or without T315I mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCR-ABL inhibitor (ponatinib, imatinib, dasatinib, nilotinib, bosutinib, asciminib)
previously treated with and developed resistance or intolerance to at least two TKIs including ponatinib, imatinib, dasatinib, nilotinib, bosutinib, and asciminib
Cannot have received: HQP1351 (HQP1351)
Patients who had been treated with HQP1351
Lab requirements
Kidney function
Creatinine < 2 × ULN; or, creatinine > 2 × ULN, with 24h GFR ≥ 30 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin < 1.5 × ULN; AST and ALT < 3 × ULN for institution (<5×ULN if liver involvement with leukemia)
Cardiac function
LVEF > 50%; Normal QTcF interval on ECG: male ≤450ms, female ≤470ms
Creatinine < 2 × ULN; or, creatinine > 2 × ULN, with 24h GFR ≥ 30 mL/min (Cockcroft-Gault); Total bilirubin < 1.5 × ULN; AST and ALT < 3 × ULN for institution (<5×ULN if liver involvement with leukemia); LVEF > 50%; Normal QTcF interval on ECG: male ≤450ms, female ≤470ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- City of Hope · Duarte, California
- Winship Cancer Institute, Emory University · Atlanta, Georgia
- Augusta Cancer Center · Augusta, Georgia
- University of Maryland · Baltimore, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04260022 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior HQP1351 disqualifies patients from enrollment.
Does this trial require BCR?
Yes, BCR fusion is a required biomarker for enrollment.
Does this trial require ABL1?
Yes, ABL1 fusion is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify