A Phase I Study of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- QLS2309
Treatment groups
186 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov