NCT06313957 A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
| NCT ID | NCT06313957 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Peking University Cancer Hospital & Institute |
| Condition | Relapsed B-cell Non-Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2024-03-14 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06313957 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed B-cell Non-Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06313957 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06313957 currently recruiting?
Yes, NCT06313957 is actively recruiting participants. Contact the research team at songyq22622@163.com for enrollment information.
Where is the NCT06313957 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Zhengzhou, China.
Who is sponsoring the NCT06313957 clinical trial?
NCT06313957 is sponsored by Peking University Cancer Hospital & Institute. The trial plans to enroll 42 participants.