A Clinical Study of SHR-3079 in B-cell Non-Hodgkin Lymphoma

NCT07661537 | Not Yet Recruiting Phase 1

• 1 other identifier: SHR-3079-101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

B-cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (3)

• Dose-limiting Toxicity (DLT)

  28 days after treatment initiation.

• Maximum tolerated dose (MTD)

  Approximately 1 year.

• Recommended Phase II Dose (RP2D)

  Approximately 1 year.

Secondary Outcomes (14)

• Types, incidence and severity of Adverse events (AEs)

  Approximately 1 year.

• Serious adverse events (SAEs)

  Approximately 1 year.

• Peak concentration (Cmax)

  Approximately 1 year.

• Time to peak concentration (Tmax)

  Approximately 1 year.

• Area under the curve (AUC0-t, AUC0-inf)

  Approximately 1 year.

Study Arms (1)

SHR-3079 Group

EXPERIMENTAL

SHR-3079.

Drug: SHR-3079 Injection

Interventions

SHR-3079 Injection DRUG

SHR-3079 injection.

SHR-3079 Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Wei Ji, M.M

CONTACT

+86-0518-82342973; wei.ji.wj10@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

Model Details: SHR-3079 Monotherapy.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

CN (2)