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A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies

NCT07347171 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-01-16

No results posted yet for this study

Summary

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.

Conditions

  • Leukemia
  • AML
  • MDS
  • AML (Acute Myelogenous Leukemia)
  • MDS (Myelodysplastic Syndrome)

Interventions

DRUG

CG009301 for Injection

0.9% Sodium Chloride Injection diluted to 250mL，Cycle 1 and subsequent cycles, IV, infusion duration: 2 hours, once daily (QD) administration for 7 days continuously(28 days constituting one cycle)

Sponsors & Collaborators

  • Cullgen (Shanghai),Inc

    lead OTHER

Principal Investigators

  • Jianxiang Wang, MS · The Haematology Hospital of the Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-17
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07347171 on ClinicalTrials.gov