HRS-3005 in B-cell Malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial investigates the safety and tolerability of HRS-3005 in adults with relapsed or refractory B-cell malignancies. The study aims to identify the maximum tolerated dose if possible and determine a recommended dose for Phase 2. Participants have measurable disease, adequate organ function, and good performance status, and must use contraception as required. The trial is conducted at a single center in Tianjin, China, sponsored by Jiangsu HengRui Medicine Co., Ltd. Early efficacy will be explored alongside safety data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years;
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
3. Life expectancy ≥12 weeks;
4. Histologically or cytologically confirmed relapsed/refractory B-cell malignancies;
5. Measurable disease;
6. Adequate organ function;
7. Females of childbearing potential must not be pregnant or lactating. Females of childbearing potential and males with partners of childbearing potential must agree to use effective contraception from the time of informed consent until 28 days after the last dose of study treatment;
8. Voluntary participation with signed informed consent, good compliance, and willingness to complete follow-up visits.

Exclusion Criteria:

1. Known central nervous system (CNS) involvement by malignancy;
2. History of other malignancy within 2 years prior to first dose of study drug, except for the disease under study;
3. Prior autologous stem cell transplantation or CAR-T therapy within 12 weeks before first dose of study drug;
4. Prior allogeneic hematopoietic stem cell transplantation;
5. Positive hepatitis B surface antigen (HBsAg) with detectable HBV-DNA at screening;
6. Positive hepatitis C antibody with detectable HCV-RNA at screening;
7. Positive HIV antigen/antibody test at screening;
8. Active fungal, bacterial, and/or viral infection requiring systemic therapy;
9. Major surgery or significant trauma within 28 days prior to first dose of study drug;
10. Severe disease of major organ systems;
11. Prior anti-tumor treatment-related adverse events not recovered to ≤Grade 1 or stable status;
12. Incomplete washout period from prior anti-tumor therapy before first dose of study drug;
13. Use of strong or moderate CYP3A inducers, or strong or moderate CYP3A inhibitors within 14 days prior to first dose of study drug;
14. Live vaccine administration within 28 days prior to first dose of study drug;
15. Ongoing alcohol or drug abuse;
16. Intracranial hemorrhage within 6 months prior to first dose of study drug;
17. Currently receiving vitamin K antagonists or Factor Xa inhibitors;
18. History of severe bleeding disorder, such as coagulation factor deficiency or von Willebrand factor (vWF) deficiency;
19. Inability to swallow oral medication, or presence of severe gastrointestinal disease or prior surgery significantly affecting gastrointestinal function;
20. Pregnant or lactating females;
21. Concurrent participation in another interventional clinical study, or less than 1 month between signing informed consent and last dose of previous clinical study.

Where it's running

• Hematology Hospital of the Chinese Academy of Medical Sciences
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Wanyi Zhai
• Email: wanyi.zhai.wz5@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.