OncoMatch/Clinical Trials/NCT07347171
A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies
Is NCT07347171 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CG009301 for for leukemia.
Treatment: CG009301 for — The goal of this clinical trial is to learn about the safety of drug CG009301. It also learns if drug CG009301 works to treat in Participants with relapsed or refractory adult haematological malignancies. The main question\[s\] it aims to answer are: 1. To determine the maximum tolerated dose (MTD) and/or objective best dose (OBD) of CG009301 for injection in subjects with relapsed or refractory adult haematological malignancies. 2. To establish subsequent dosing regimens for CG009301 for injection. 3. To characterise the safety profile and tolerability of CG009301 for injection. Participants will Receive treatment with CG009301 until disease progression.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment regimens
who have failed prior standard treatment regimens. The investigator must deem that no standard treatment is available or that the patient cannot tolerate existing therapies.
Cannot have received: autologous haematopoietic stem cell transplantation
Exception: transplantation more than 2 months prior with toxicities resolved to ≤ Grade 1
No prior autologous haematopoietic stem cell transplantation, or transplantation more than 2 months prior with toxicities resolved to ≤ Grade 1
Cannot have received: allogeneic haematopoietic stem cell transplantation
Exception: within 12 months prior to initial administration
Allogeneic haematopoietic stem cell transplantation within 12 months prior to initial administration
Cannot have received: antitumour therapy (excluding hydroxyurea and prophylactic intrathecal injections)
Exception: within 4 weeks or 5 half-lives (whichever is shorter) prior to the first study drug administration
Receipt of antitumour therapy (excluding hydroxyurea and prophylactic intrathecal injections) such as chemotherapy, immunotherapy, targeted therapy, or biological therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first study drug administration
Cannot have received: radiotherapy
Exception: within 2 weeks
receipt of radiotherapy within 2 weeks
Cannot have received: traditional Chinese herbal medicine
Exception: within 2 weeks
receipt of traditional Chinese herbal medicine within 2 weeks
Cannot have received: major surgery
Exception: within 4 weeks prior to the first study dose, or anticipated need for major surgery during the study period
Major surgery within 4 weeks prior to the first study dose, or anticipated need for major surgery during the study period
Lab requirements
Blood counts
White blood cell count may decrease below 50.0 × 10⁹/L at baseline or following hydroxyurea administration
Kidney function
Cr ≤ 2× ULN or CrCL > 30 mL/min (Cockcroft-Gault formula)
Liver function
serum total bilirubin ≤ 2× ULN; AST and/or ALT ≤ 2.5× ULN
Cardiac function
LVEF ≥ 40%; QTc ≤ 480 milliseconds
Adequate organ function support, with screening laboratory tests meeting all criteria: a. Coagulation function prior to study drug administration: INR ≤ 1.5 × ULN or aPTT ≤ 1.5 × ULN; b. Hepatic function: serum total bilirubin ≤ 2× ULN; AST and/or ALT ≤ 2.5× ULN; c. Cr ≤ 2× ULN or CrCL > 30 mL/min (calculated using Cockcroft-Gault formula); d. LVEF ≥ 40%; and QTc ≤ 480 milliseconds; e. White blood cell count may decrease below 50.0 × 10⁹/L at baseline or following hydroxyurea administration
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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