Phase I Study of HRS-3005 in B-cell Malignancies

An Open-Label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-3005 in Patients With B-cell Malignancies

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.

Study Overview

• Status: Not yet recruiting
• Conditions: B-cell Malignancy
• Intervention / Treatment: Drug: HRS-3005

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wanyi Zhai; Phone Number: +86-0518-82342973; Email: wanyi.zhai.wz5@hengrui.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Hematology Hospital of the chinese Academy of Medical Sciences
      • Principal Investigator: Lugui Qiu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS-3005	Drug: HRS-3005; HRS-3005

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety Endpoints: Incidence of adverse events (AEs)，number of participants with abnormal laboratory test results .	approximately 1 year
MTD（Maximum tolerated dose）	28 days after treatment initiation
RP2D（Recommended Phase II Dose）	approximately 2 year.

Secondary Outcome Measures

Outcome Measure	Time Frame
Peak Concentration (Cmax)	12 weeks after treatment initiation
Time to Peak Concentration (Tmax)	12 weeks after treatment initiation;
Area Under the Curve (AUC0-t, AUC0-inf)	12 weeks after treatment initiation;
Half-life (t1/2)	12 weeks after treatment initiation;
Apparent Clearance (CL/F)	12 weeks after treatment initiation;
Apparent Volume of Distribution (Vz/F)	12 weeks after treatment initiation
Objective Response Rate (ORR)	approximately 1 year;
Time to Response (TTR)	approximately 1 year;
Duration of Response (DoR)	approximately 1 year;
Progression-Free Survival (PFS)	approximately 1 year;
Overall Survival (OS)	approximately 1 year

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HRS-3005-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No