B-cell Non-Hodgkin LymphomaPhase 1NCT07661537
A Clinical Study of SHR-3079 in B-cell Non-Hodgkin Lymphoma
A Phase 1 study testing SHR-3079 Injection in people with B-cell Non-Hodgkin Lymphoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non-Hodgkin Lymphoma
- What is being tested?
- SHR-3079 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 23 Jul 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
- Aged ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;
- Histologically confirmed B-NHL;
- 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;
- Have measurable lesions;
- Have adequate organ function;
- 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;
- Voluntarily sign the ICF, have good compliance, and be willing to cooperate with follow-up.
Who cannot join
- Central nervous system (CNS) infiltration;
- Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment;
- Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period;
- Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment;
- Receipt of allogeneic hematopoietic stem cell transplantation;
- Prior solid organ transplantation;
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- 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;
- Presence of severe disorders involving major organ systems;
- Pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
- Pregnant, lactating women, or women planning to become pregnant;
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuqin Song, 8610-88196118, SongYQ22622@163.com
Yuqin Song
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Qingqing Cai, 8620-87342823, caiqq@sysucc.org.cn
Qingqing Cai
About this study
Official title: An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3079 Injection in Participants With B-Cell Non-Hodgkin Lymphoma
The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma.
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Being tested
- SHR-3079 Injection
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-3079 InjectionDrug
SHR-3079 injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-3079 Group | Experimental | SHR-3079. Receives: Drug: SHR-3079 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity (DLT)
Measured: 28 days after treatment initiation.
Maximum tolerated dose (MTD)
Measured: Approximately 1 year.
Recommended Phase II Dose (RP2D)
Measured: Approximately 1 year.
Secondary outcomes (14)
Types, incidence and severity of Adverse events (AEs)
Safety endpoints.
Measured: Approximately 1 year.
Serious adverse events (SAEs)
Safety endpoints.
Measured: Approximately 1 year.
Peak concentration (Cmax)
Pharmacokinetics (PK) Parameters.
Measured: Approximately 1 year.
Time to peak concentration (Tmax)
Pharmacokinetics (PK) Parameters.
Measured: Approximately 1 year.
Area under the curve (AUC0-t, AUC0-inf)
Pharmacokinetics (PK) Parameters.
Measured: Approximately 1 year.
Half-life (t1/2)
Pharmacokinetics (PK) Parameters.
Measured: Approximately 1 year.
Apparent clearance (CL/F)
Pharmacokinetics (PK) Parameters.
Measured: Approximately 1 year.
Apparent volume of distribution (Vz/F)
Pharmacokinetics (PK) Parameters.
Measured: Approximately 1 year.
Objective Response Rate (ORR)
Preliminary efficacy endpoints.
Measured: Approximately 1 year.
Best Overall Efficacy(BOR)
Preliminary efficacy endpoints.
Measured: Approximately 1 year.
Time to Response (TTR)
Preliminary efficacy endpoints.
Measured: Approximately 1 year.
Duration of Response (DoR)
Preliminary efficacy endpoints.
Measured: Approximately 1 year.
Progression-Free Survival (PFS)
Preliminary efficacy endpoints.
Measured: Approximately 1 year.
Overall Survival (OS)
Preliminary efficacy endpoints.
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 posted22 Jun 2026
- Study start23 Jul 2026
- Primary completionDec 2027 (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 Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals 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
- Model description
- SHR-3079 Monotherapy.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661537
- Sponsor's protocol ID
- SHR-3079-101
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 7 Aug 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3079 Injection in Participants With B-Cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07661537
- Acronym / sponsor ID
- SHR-3079-101
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Jun 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 SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SHR-3079 Monotherapy.
| Arm | Type | Receives |
|---|---|---|
| SHR-3079 Group | Experimental | Drug: SHR-3079 InjectionSHR-3079. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;
- Histologically confirmed B-NHL;
- 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;
- Have measurable lesions;
Key exclusion criteria (11 listed)
- Central nervous system (CNS) infiltration;
- Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment;
- Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period;
- Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment;
- Receipt of allogeneic hematopoietic stem cell transplantation;
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 |
|---|---|---|
| SHR-3079 InjectionSHR-3079 injection. | Drug | SHR-3079 Group |
Primary outcome
Dose-limiting Toxicity (DLT)
Time frame: 28 days after treatment initiation.
Maximum tolerated dose (MTD)
Time frame: Approximately 1 year.
Recommended Phase II Dose (RP2D)
Time frame: Approximately 1 year.
14 secondary outcomes
Types, incidence and severity of Adverse events (AEs)
Time frame: Approximately 1 year.
Serious adverse events (SAEs)
Time frame: Approximately 1 year.
Peak concentration (Cmax)
Time frame: Approximately 1 year.
Time to peak concentration (Tmax)
Time frame: Approximately 1 year.
Area under the curve (AUC0-t, AUC0-inf)
Time frame: Approximately 1 year.
Half-life (t1/2)
Time frame: Approximately 1 year.
Apparent clearance (CL/F)
Time frame: Approximately 1 year.
Apparent volume of distribution (Vz/F)
Time frame: Approximately 1 year.
Objective Response Rate (ORR)
Time frame: Approximately 1 year.
Best Overall Efficacy(BOR)
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 7 Aug 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-3079 Injection in people with B-cell Non-Hodgkin Lymphoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites 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 11 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Wei Ji, M.M (+86-0518-82342973, wei.ji.wj10@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicity (DLT) (time frame: 28 days after treatment initiation.). 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 7 Aug 2026.