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

NCT07556822 | Not Yet Recruiting Phase 1

• 1 other identifier: HRS-3005-101
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

B-cell Malignancy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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;

Study Arms (1)

Treatment group A: HRS-3005

EXPERIMENTAL

Drug: HRS-3005

Interventions

HRS-3005 DRUG

HRS-3005

Treatment group A: HRS-3005

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Measurable disease;
• Adequate organ function;
• 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;
• Voluntary participation with signed informed consent, good compliance, and willingness to complete follow-up visits.

You may not qualify if:

• 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;
• Positive hepatitis B surface antigen (HBsAg) with detectable HBV-DNA at screening;
• Positive hepatitis C antibody with detectable HCV-RNA at screening;
• Positive HIV antigen/antibody test at screening;
• Active fungal, bacterial, and/or viral infection requiring systemic therapy;
• Major surgery or significant trauma within 28 days prior to first dose of study drug;
• Severe disease of major organ systems;
• Prior anti-tumor treatment-related adverse events not recovered to ≤Grade 1 or stable status;
• Incomplete washout period from prior anti-tumor therapy before first dose of study drug;
• Use of strong or moderate CYP3A inducers, or strong or moderate CYP3A inhibitors within 14 days prior to first dose of study drug;
• Live vaccine administration within 28 days prior to first dose of study drug;
• Ongoing alcohol or drug abuse;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Location

Central Study Contacts

Wanyi Zhai

CONTACT

+86-0518-82342973; wanyi.zhai.wz5@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 29, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CN (1)