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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
HRS-3005
DrugHRS-3005
Treatment groups
190 Participants
are divided into 1 treatment groupGroup A: Treatment group A: HRS-3005Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety Endpoints: Incidence of adverse events (AEs)，number of participants with abnormal laboratory test results .
Time frame
approximately 1 year2
MTD（Maximum tolerated dose）
Time frame
28 days after treatment initiation3
RP2D（Recommended Phase II Dose）
Time frame
approximately 2 year.Secondary outcomes
1
Peak Concentration (Cmax)
Time frame
12 weeks after treatment initiation2
Time to Peak Concentration (Tmax)
Time frame
12 weeks after treatment initiation;3
Area Under the Curve (AUC0-t, AUC0-inf)
Time frame
12 weeks after treatment initiation;4
Half-life (t1/2)
Time frame
12 weeks after treatment initiation;Sponsors and contacts
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Source ClinicalTrials.gov