Treatment of relapsed or refractory B-cell non-Hodgkin lymphoma with LUCAR-20SP
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-20SP, an Allogenic Chimeric Antigen Receptor(CAR)-T Cell Therapy Targeting CD20 in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
This study is testing a new CAR-T cell therapy called LUCAR-20SP to see if it can help adults with tough cases of relapsed or refractory B-cell non-Hodgkin lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Trial ID | NCT06313957 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of LUCAR-20SP, an allogenic CAR-T cell therapy, in adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Participants will undergo a series of stages including screening, pre-treatment with lymphodepleting chemotherapy, treatment with LUCAR-20SP infusion, and follow-up. The study aims to gather data on the effectiveness of this innovative therapy in managing challenging cases of lymphoma.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma and an ECOG score of 0-1.
Not a fit: Patients who have previously received allogeneic cell and gene therapy or hematopoietic stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell non-Hodgkin lymphoma.
How similar studies have performed: Other studies involving CAR-T cell therapies have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects voluntarily participate in clinical research; * Age ≥18 years old; * Eastern Cooperative Oncology Group (ECOG) score 0-1; * Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, histologically indolent lymphoma to diffuse large B-cell lymphoma; CD20 positive; * At least one measurable tumor lesion according to the Lugano 2014. * Expected survival ≥3 months; * Clinical laboratory values in the screening period meet criteria. * Effective contraception. Exclusion Criteria: * Prior antitumor therapy with insufficient washout period. * Previous treatment with allogeneic cell and gene therapy (such as CAR-T); Except subjects with evidence that previous allogeneic cell and gene therapy products (such as CAR-positive T cells and CAR transgenes) in the subject have been below the lower limit of detection; * Previously received allogeneic hematopoietic stem cell transplantation; * Previously received gene therapy; * Donor specific antibody (DSA) positive subjects will be excluded; * Severe underlying diseases; * Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive; * Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
Where this trial is running
Beijing, Beijing Municipality and 2 other locations
- Beijing GoBroad Boren Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking University Cancer Hospital & Institute — Beijing, Beijing Municipality, China (Recruiting)
- Henan Cancer Hospital — Zhengzhou, China (Recruiting)
Study contacts
- Study coordinator: Yuqin Song
- Email: songyq22622@163.com
- Phone: 13683398726
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.