Combining SHR-A1912 with other therapies for B-cell Non-Hodgkin's Lymphoma
A Phase Ib/II Study of SHR-A1912 Combined With Other Therapies in Patients With B-cell Non-Hodgkin 's Lymphoma
This study is testing if combining a new treatment called SHR-A1912 with other therapies can help people with B-cell non-Hodgkin's lymphoma feel better and fight their cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | Car-T |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06104553 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, pharmacokinetics, and preliminary anti-tumor activity of SHR-A1912 when combined with other therapies in patients diagnosed with B-cell non-Hodgkin's lymphoma. The study includes both relapsed/refractory patients and those who are treatment-naïve, aiming to assess the effectiveness of this combination therapy. Participants will be monitored for their response to treatment and any potential side effects throughout the trial phases.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed B-cell non-Hodgkin's lymphoma who have either relapsed/refractory disease or are treatment-naïve.
Not a fit: Patients who have recently undergone stem cell transplantation or received CAR-T cell therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from B-cell non-Hodgkin's lymphoma.
How similar studies have performed: Other studies have shown promise in combining therapies for B-cell non-Hodgkin's lymphoma, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age greater than or equal to18 years old; 2. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1; 3. Life expectancy \>3 months; 4. Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma; 5. Previous systematic anti-tumor therapy should meet the following requirements: 1) Relapsed and/or refractory disease after at least one (≥ 1) line of prior systemic therapy (relapsed/refractory cohort); 2) Previously untreated (naïve cohort). 6. At least one measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one measurable extra nodal lesion, defined as \> 1.0 cm in its longest diameter. Exclusion Criteria: 1. Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment; 2. History of recent major surgery or severe trauma within 4 weeks before the first study treatment; 3. Received anti-tumour treatment within 2 weeks before the first study treatment; 4. Central nervous system (CNS) infiltration; 5. Active infection with HBV or HCV; 6. History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis; 7. Active infection or unexplained fever\>38.5℃; 8. History of severe cardiovascular disease.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhenyu Xiao, Medical Director
- Email: zhenyu.xiao.zx7@hengrui.com
- Phone: 021-61053363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.