Phase I Study of HRS-3005 in B-cell Malignancies
ConditionB-cell Malignancy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
The study is being conducted to evaluate the safety and tolerability of HRS-3005. To explore the Maximum Tolerated Dose (MTD, if possible) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of HRS-3005 in patients with B-cell malignancy.
Eligibility criteria
Qualifiers
Age ≥18 years;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
Life expectancy ≥12 weeks;
Histologically or cytologically confirmed relapsed/refractory B-cell malignancies;
Disqualifiers
Known central nervous system (CNS) involvement by malignancy;
History of other malignancy within 2 years prior to first dose of study drug, except for the disease under study;
Prior autologous stem cell transplantation or CAR-T therapy within 12 weeks before first dose of study drug;
Prior allogeneic hematopoietic stem cell transplantation;
Trial design
Treatments tested in this trial
- HRS-3005
Treatment groups
190 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov