A Phase I Study of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies

NCT07173595 | Recruiting Phase 1

• 1 other identifier: QLS2309-101
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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 antitumor activity of QLS2309 injection in patients with CD70+ relapsed/refractory hematologic malignancies.

Conditions

Relapsed or Refractory Hematologic Malignancies

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity(DLT)

  To evaluate the safety and tolerability of QLS2309

  28 days

• Recommended Phase Ib Dose (RPIbD)

  The Safety Monitoring Committee (SMC) will select RP1bD based on the safety, tolerability, PK parameters, pharmacodynamics, preliminary effectiveness and other data of subjects in different dose groups

  up to 2 years

Study Arms (1)

QLS2309

EXPERIMENTAL

Drug: QLS2309

Interventions

QLS2309 DRUG

initial dose - MTD; QW; intravenous infusion

QLS2309

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Xiaojun Huang, MD

CONTACT

01088316617; xjhrm@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 15, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (1)