Clinical trial · Interventional
CAR-T Cells in Treating Patients With Relapsed or Refractory NHL
An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Non-Hodgkin Lymphoma (NHL)
NCT04626739CI-TRIAL-00048259unknownEarly Phase 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 an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.
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 |
|---|---|---|---|
| Refractory Indolent Adult Non-Hodgkin Lymphoma | Indolent Adult Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CAR-T | Drug | — | UNRESOLVED |
| CD19+CD22 CAR-T | Drug | — | UNRESOLVED |
| CD22 CAR-T | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- volunteers
- description
- The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) non-Hodgkin lymphoma
- interventionNames
- Drug: CD19 CAR-T
- Drug: CD22 CAR-T
- Drug: CD19+CD22 CAR-T
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (2)
- measure
- Number of Participants with Severe/Adverse Events as a Measure of Safety
- timeFrame
- 28 days
- description
- Number of Participants with Severe/Adverse Events as a Measure of Safety
- measure
- CAR-T Cell expansion level
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Fully understand and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment protocol, laboratory examination and other requirements of the study as set out in the trial procedure sheet; 2. Cd19-positive R/R NHL patients: recurrent or refractory patients were defined as diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), mucosa-associated lymphoid tissue lymphoma (MALTL), and Burkit lymphoma (BL) diagnosed by histopathology. To standard treatment for primary drug resistance, or after treatment for at least two line standard specification treatment of PD, or the last treatment effect for SD and duration less than 6 months, or CD20 positive patients by the resistance against CD20 single treatment is invalid or has a relapse, or autologous hematopoietic stem cell transplantation in PD or 12 months after the confirmed by biopsy has a relapse, or to save patients after autologous hematopoietic stem cell transplantation for at the end of the line no ease or relapse after treatment; 3. There should be at least one measurable tumor focal point; 4. Karnofsky \[2\] score 50 or more; 5. Tumor cells were CD19 positive by immunohistochemistry or flow cytometry; 6. The expected survival time is greater than 3 months; 7. Pregnancy tests for women of childbearing age must be negative; Both men and women should agree to use effective contraceptives during treatment and for the following 1 year; Exclusion Criteria: 1. Serious cardiac insufficiency, left ventricular ejection fraction\<50; 2. Has a history of severe pulmonary function damaging; 3. Merging other malignant tumor; 4. Merging uncontrolled infection; 5. Merging the metabolic diseases (except diabetes); 6. Merging severe autoimmune diseases or immunodeficiency disease; 7. patients with active hepatitis B or hepatitis C; 8. patients with HIV infection; 9. Has a history of serious allergies on Biological products (including antibiotics); 10. Happened in 3 \~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients; 11. Pregnancy or lactation women; 12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
References
Publications (0)
Data not yet available
No reference posted for this study.