Status:
RECRUITING
A Phase I Study of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Relapsed or Refractory Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a single-arm, open-label, multicenter, dose-escalation, dose-expansion and efficacy-expansion phase I clinical study to evaluate the tolerability, safety, pharmacokinetics and preliminary anti...
Eligibility Criteria
Inclusion
- 1\. Subjects voluntarily participated and signed a written informed consent form
- Age ≥ 18 years, male or female
- ECOG performance status of 0-2
- Expected life-expectancy ≥ 3 months
- CD70+ relapsed/refractory hematologic malignancies
- Adequate organ function prior to QLS2309 administration
- Female patients with fertility must agree to the use of effective contraceptive methods during the study period and within 35 days of discontinuation of the trial drug.
- Male patients whose sexual partners are women of childbearing age must agree to use condoms during the study period and within 35 days of discontinuation of the trial drug during sexual intercourse.
Exclusion
- Prior treatment with CD70-related antibodies, antibody-conjugated drugs (ADCs) or cell therapy products
- Symptomatic central nervous system (CNS) involvement, leptomeningeal metastasis or spinal cord compression caused by metastasis
- An active autoimmune diseases or known history of ≥ grade 3 irAE due to prior immunotherapy
- Known history of other active malignant tumor within 3 years
- Known history of chemotherapy, biological therapy, endocrine therapy, immunotherapy, monoclonal antibodies, etc. within 4 weeks
- Known history of active hepatitis B/C infection, HIV infection, Treponema pallidum infection
Key Trial Info
Start Date :
December 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT07173595
Start Date
December 5 2025
End Date
December 1 2027
Last Update
January 2 2026
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100032