A Phase I Study of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLS2309.
- Who it may be relevant to
- Registry conditions: Relapsed or Refractory Hematologic Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies
Overview
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 antitumor activity of QLS2309 injection in patients with CD70+ relapsed/refractory hematologic malignancies.
Interventions
- Drug QLS2309
initial dose - MTD; QW; intravenous infusion
Primary outcome measures
- Dose-limiting toxicity(DLT) [Time frame: 28 days]
- Recommended Phase Ib Dose (RPIbD) [Time frame: up to 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07173595 · QLS2309-101