Clinical trial · Interventional
A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
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
NCT06313957CI-TRIAL-00087677recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory B-cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed B-cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LUCAR-20SP cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Each subject will receive LUCAR-20SP cells
- description
- Chimeric antigen receptor T cells LUCAR-20SP cells
- interventionNames
- Biological: LUCAR-20SP cells
Primary outcomes (5)
- measure
- Dose-limiting toxicity (DLT) rate
- timeFrame
- Minimum 2 years after LUCAR-20SP infusion (Day 1)
- description
- DLT refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
- measure
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
- timeFrame
- Minimum 2 years after LUCAR-20SP infusion (Day 1)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.