B-cell MalignancyPhase 1NCT07556822
Phase I Study of HRS-3005 in B-cell Malignancies
A Phase 1 study testing HRS-3005 in people with B-cell Malignancy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Malignancy
- What is being tested?
- HRS-3005
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2026to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Intracranial hemorrhage within 6 months prior to first dose of study drug;
- Currently receiving vitamin K antagonists or Factor Xa inhibitors;
- History of severe bleeding disorder, such as coagulation factor deficiency or von Willebrand factor (vWF) deficiency;
- Inability to swallow oral medication, or presence of severe gastrointestinal disease or prior surgery significantly affecting gastrointestinal function;
- Pregnant or lactating females;
- Concurrent participation in another interventional clinical study, or less than 1 month between signing informed consent and last dose of previous clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Lugui Qiu
About this study
Official title: 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.
- Conditions
- B-cell Malignancy
- Being tested
- HRS-3005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-3005Drug
HRS-3005
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS-3005 | Experimental | Not described Receives: Drug: HRS-3005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoints: Incidence of adverse events (AEs)，number of participants with abnormal laboratory test results .
Measured: approximately 1 year
MTD（Maximum tolerated dose）
Measured: 28 days after treatment initiation
RP2D（Recommended Phase II Dose）
Measured: approximately 2 year.
Secondary outcomes (11)
Peak Concentration (Cmax)
Measured: 12 weeks after treatment initiation
Time to Peak Concentration (Tmax)
Measured: 12 weeks after treatment initiation;
Area Under the Curve (AUC0-t, AUC0-inf)
Measured: 12 weeks after treatment initiation;
Half-life (t1/2)
Measured: 12 weeks after treatment initiation;
Apparent Clearance (CL/F)
Measured: 12 weeks after treatment initiation;
Apparent Volume of Distribution (Vz/F)
Measured: 12 weeks after treatment initiation
Objective Response Rate (ORR)
Measured: approximately 1 year;
Time to Response (TTR)
Measured: approximately 1 year;
Duration of Response (DoR)
Measured: approximately 1 year;
Progression-Free Survival (PFS)
Measured: approximately 1 year;
Overall Survival (OS)
Measured: approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start3 Jun 2026
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell MalignancyStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556822
- Sponsor's protocol ID
- HRS-3005-101
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07556822
- Acronym / sponsor ID
- HRS-3005-101
- Conditions
- B-cell Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS-3005 | Experimental | Drug: HRS-3005 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-3005HRS-3005 | Drug | Treatment group A: HRS-3005 |
Primary outcome
Safety Endpoints: Incidence of adverse events (AEs)，number of participants with abnormal laboratory test results .
Time frame: approximately 1 year
MTD（Maximum tolerated dose）
Time frame: 28 days after treatment initiation
RP2D（Recommended Phase II Dose）
Time frame: approximately 2 year.
11 secondary outcomes
Peak Concentration (Cmax)
Time frame: 12 weeks after treatment initiation
Time to Peak Concentration (Tmax)
Time frame: 12 weeks after treatment initiation;
Area Under the Curve (AUC0-t, AUC0-inf)
Time frame: 12 weeks after treatment initiation;
Half-life (t1/2)
Time frame: 12 weeks after treatment initiation;
Apparent Clearance (CL/F)
Time frame: 12 weeks after treatment initiation;
Apparent Volume of Distribution (Vz/F)
Time frame: 12 weeks after treatment initiation
Objective Response Rate (ORR)
Time frame: approximately 1 year;
Time to Response (TTR)
Time frame: approximately 1 year;
Duration of Response (DoR)
Time frame: approximately 1 year;
Progression-Free Survival (PFS)
Time frame: approximately 1 year;
Overall Survival (OS)
Time frame: approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-3005 in people with B-cell Malignancy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanyi Zhai (+86-0518-82342973, wanyi.zhai.wz5@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoints: Incidence of adverse events (AEs)，number of participants with abnormal laboratory test results . (time frame: approximately 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.