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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
QLS2309
Druginitial dose - MTD; QW; intravenous infusion
Treatment groups
186 Participants
are divided into 1 treatment groupGroup A: QLS2309Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity(DLT)
To evaluate the safety and tolerability of QLS2309
Time frame
28 days2
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
Time frame
up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov