QLS2309 injections for adults with CD70-positive relapsed or refractory blood cancers.

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

This trial will try QLS2309 injections to see if they are safe, tolerated, and show early anti-cancer effects in adults with CD70-positive relapsed or refractory blood cancers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07173595 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, multicenter Phase I trial using dose-escalation followed by dose-expansion and efficacy-expansion cohorts to define tolerability, safety, pharmacokinetics and preliminary antitumor activity of QLS2309. Eligible participants are adults with relapsed or refractory hematologic malignancies that express CD70 and who meet performance status and organ-function requirements. The trial excludes patients with prior CD70-targeted therapies, symptomatic CNS involvement, or active autoimmune disease, among other criteria. Serial safety monitoring and pharmacokinetic sampling will be performed alongside tumor response assessments.

Who should consider this trial

Good fit: Adults (≥18) with confirmed CD70-positive relapsed or refractory hematologic malignancies, ECOG 0-2, adequate organ function, and no prior CD70-directed therapies are the ideal candidates.

Not a fit: Patients with prior CD70-targeted antibody/ADC or cell therapies, active CNS involvement, uncontrolled autoimmune disease, poor organ function, or who are pregnant are unlikely to benefit or to be eligible.

Why it matters

Potential benefit: If successful, QLS2309 could provide a new targeted treatment option that may shrink tumors or control disease in patients with CD70-positive relapsed or refractory blood cancers.

How similar studies have performed: Other CD70-targeted agents and antibody–drug conjugates have shown preliminary activity in some blood cancers, but QLS2309 itself is investigational with limited published outcome data.

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

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaojun Huang, MD

Conditions Relapsed or Refractory Hematologic Malignancies