Phase I Study of HRS-1635 in B-cell Malignancies
ConditionB-cell Malignancy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChengdu Suncadia Medicine Co., Ltd.
About this trial
The study is being conducted to evaluate the safety and tolerability of HRS-1635. To observe the Dose-Limiting Toxicity (DLT) , explore the Maximum Tolerated Dose (MTD, if possible) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of HRS-1635 in participants with B-cell malignancy.
Eligibility criteria
Qualifiers
Age ≥ 18 years old;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
Expected survival time ≥ 12 weeks;
Histologically or cytologically confirmed relapsed/refractory B-cell malignant tumor;
Disqualifiers
Tumor infiltration of the central nervous system;
A history of other malignant tumors (excluding the study disease) within 2 years prior to the first administration of the study drug;
A history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
Positive for hepatitis B surface antigen (HBsAg) at screening with evidence of viral replication confirmed by HBV-DNA test;
Trial design
Treatments tested in this trial
- HRS-1635
Treatment groups
180 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov