Clinical trial · Interventional
CD19/CD20 Dual-CAR-T in B-cell Non-Hodgkin's Lymphoma Patients.
A Study of CD19/CD20 Dual CAR-T Cells in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma(B-NHL)
NCT04697290CI-TRIAL-00056524suspendedEarly Phase 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): Plan adjustment
Summary
Brief summary (as posted)
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory or relapsed B-NHL.
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 |
|---|---|---|---|
| B-cell Non-Hodgkin's Lymphoma | B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19/CD20 Dual-CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19/CD20 Dual-CAR-T cells
- description
- CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for at least 2 days before infusion.
- interventionNames
- Biological: CD19/CD20 Dual-CAR-T cells
Primary outcomes (2)
- measure
- Percentage of adverse events
- timeFrame
- 6months
- description
- Percentage of participants with adverse events.
- measure
- Objective remission rate(ORR)
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years 2. NHL confirmed by cytology or histology, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, etc. 3. Relapse or refractory after at least second-line treatment; 4. With evaluable target lesions.Measurable target lesions: lymph nodes\>1.5x1.0cm, extranodal lesions\>1.0x1.0cm; 5. Double positive expression of CD19 / CD20 in B cells; 6. ECOG score 0-2 points; 7. Good organ function: Blood routine: absolute neutrophil count (ANC) ≥1.0×109/L; hemoglobin (Hb) ≥80 g/L; platelet count (PLT) ≥50×109/L; Blood biochemistry: total bilirubin≤3×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3×upper limit of normal (ULN); Pulmonary function: ≤CTCAE Grade 1 dyspnea and SaO2≥92% in indoor air environment; Heart function: Left ventricular ejection fraction (LVEF) ≥50%. 8. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside; 9. Patients who voluntarily sign informed consent and are willing to comply with treatment plans. Exclusion Criteria: 1. Active infections that are difficult to control; 2. Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) antibody positive, and Treponema pallidum antibody test positive; 3. The tumor invades the central nervous system or primary CNS lymphoma; 4. Anti-GVHD (acute or chronic) treatment is being performed within 4 weeks before apheresis and cell infusion; 5. Have undergone the following treatments: * Those who have received chemotherapy or radiotherapy 5 days before apheresis; * Those who have used drugs that stimulate the production of bone marrow hematopoietic cells within 5 days before apheresis; * Received donor lymphocyte infusion (DLI) within 6 weeks before cell infusion; * Have received autologous hematopoietic stem cell transplantation (HSCT) 3 months before apheresis, or received allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 12 months; * Have used any gene therapy products before; 6. History of epilepsy or other central nervous system diseases; or clinically diagnosed as having severe thyroid dysfunction; or active autoimmune diseases; 7. History of other malignant tumors that have not been remission for at least 3 years ; 8. Any of the following cardiovascular diseases occurred within 6 months of the screening period, including NYHA heart function grade III or IV heart failure, cardiovascular angioplasty or stent, myocardial infarction, unstable angina, or other clinical symptoms Significant heart disease; 9. Pregnant or lactating women; 10. The investigator believes that there are other factors that are not suitable for selection or that affect subjects' participation or completion of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.