New drug candidate SHR-3079 targets Hard-to-Treat lymphoma
NCT ID NCT07661537
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial tests a new drug called SHR-3079 in adults with B-cell non-Hodgkin lymphoma whose cancer has not responded to at least one prior standard treatment. The main goals are to check the drug's safety, find the best dose, and get an early look at whether it can shrink tumors. Participants receive SHR-3079 injections and are monitored for side effects and drug levels in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-3079 injection
- What this could lead to
- If successful, this could lead to a new treatment option for people with B-cell non-Hodgkin lymphoma who have not responded to standard therapies.
- What could go wrong
- This is an early Phase 1 trial with only 90 participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to show benefit.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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. Aged ≥ 18 years old; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months; 3. Histologically confirmed B-NHL; 4. Participant population: Have received ≥ 1 line of standard anti-tumor treatment, and have not achieved response after the latest treatment or have progressive disease after the treatment; 5. Have measurable lesions; 6. Have adequate organ function; 7. Male participants and female participants of childbearing potential must use adequate and effective contraceptive measures during the study and within 3 months after the last drug administration of SHR-3079. Female participants must not be lactating and must have a negative blood HCG test result within 7 days before the first dose; 8. Voluntarily sign the ICF, have good compliance, and be willing to cooperate with follow-up. Exclusion Criteria: 1. Central nervous system (CNS) infiltration; 2. Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment; 3. Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period; 4. Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment; 5. Receipt of allogeneic hematopoietic stem cell transplantation; 6. Prior solid organ transplantation; 7. Positive hepatitis C virus (HCV) antibody with HCV-RNA copy number above the upper limit of normal of the study site; positive hepatitis B surface antigen \[HBsAg\] and/or positive hepatitis B core antibody (HBcAb) with HBV DNA copy number above the upper limit of normal of the study site; 8. Presence of severe disorders involving major organ systems; 9. Pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention; 10. Pregnant, lactating women, or women planning to become pregnant; 11. Have other serious physical or mental illness, laboratory test abnormalities, or other factors that may increase the risk of study participation or interfere with the study results.
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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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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- Experimental antibody drug shows promise for Hard-to-Treat lymphoma