Clinical trial · Interventional
Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-G39P, a Dual-targeted Cell Preparation Targeting CD19/CD20, in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
NCT06295549CI-TRIAL-00098147terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Achieve the proof of concept.
Summary
Brief summary (as posted)
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed and Refractory B-cell Non-Hodgkin Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LUCAR-G39P cells product | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: LUCAR-G39P cells product
- description
- Each subject will be given a single-dose LUCAR-G39P cells infusion at each dose level.
- interventionNames
- Biological: LUCAR-G39P cells product
Primary outcomes (4)
- measure
- Incidence, severity and type of TEAEs
- timeFrame
- Through study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
- description
- An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
- measure
- Pharmacokinetics in peripheral blood
- timeFrame
- ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.
2. Aged 18-75 years (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
5. At least one evaluable tumor lesion according to Lugano 2014 criteria.
Response to prior therapy is consistent with one of the following:
1. Primary refractory.
2. Relapsed or refractory after 2 or more lines of therapy.
3. For LBCL, 3B FL. t-iNHL:
* Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
* Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;
7\. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria
Exclusion Criteria:
Subject eligible for this study must not meet any of the following criteria:
1. Prior antitumor therapy with insufficient washout period ;
2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy;
3. Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy;
5\. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).
6\. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39P CAR-T cell or its excipients, including DMSO.
7\. Pregnant or lactating women;
\-References
Publications (0)
Data not yet available
No reference posted for this study.