A Phase I Trial of QLS2313 Injection in Relapsed/Refractory Hematological Malignancies
NCT07294300 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2025-12-19
Summary
This study is an open-label, dose-escalation and efficacy-expansion Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary antitumor activity of QLS2313 as a monotherapy in patients with relapsed/refractory hematological malignancies.
Conditions
- Relapsed/Refractory Hematological Malignancies
Interventions
- DRUG
-
QLS2313
CD79b/CD3/CD20;first in human; subcutaneous injection
Sponsors & Collaborators
-
Qilu Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2028-02-29
- Completion
- 2028-02-29
Countries
- China
Study Locations
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