New hope for tough blood cancers? early trial launches
NCT ID NCT07556822
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times
Summary
This early-phase study tests a new drug called HRS-3005 in 190 adults with B-cell blood cancers (like lymphoma or leukemia) that have returned or not responded to standard treatments. The main goals are to check the drug's safety, find the best dose, and get a first look at whether it can shrink tumors. Because it is a Phase 1 trial, the focus is on safety, not yet on proving it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-3005
- What this could lead to
- If it works, this could point toward a new treatment option for people with certain blood cancers that have not responded to other therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 190 participants, so it is too soon to know if HRS-3005 is safe or effective. Many early-stage drugs do not succeed in later trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 190 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for B-cell malignancy are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Hematology Hospital of the Chinese Academy of Medical Sciences
RECRUITINGTianjin, Tianjin Municipality, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug HRS-1635 enters early human testing for hard-to-treat blood cancers
- New drug targets Hard-to-Treat blood cancers in chinese trial
- Off-the-Shelf CAR-T cells take on tough blood cancers
- CRISPR gene editing takes on blood cancers: new trial tests donor immune cells
- New pill shows promise for Hard-to-Treat blood cancers
- New drug combo shows promise for Hard-to-Treat blood cancers