Clinical trial · Interventional
The Safety and Efficacy of Double-target CART-19 and 20 Cells in Non-Hodgkin's Lymphoma (NHL)
The Safety and Efficacy of Double-target CART-19 and 20 Cells in Relapse and Refractory Patients With CD19+/CD20+ Non-Hodgkin's Lymphoma (NHL)
NCT06160362CI-TRIAL-00072052unknownN/AClinicalTrials.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 study for patients who have been previously treated for NHL. The purpose of this study is to determine the safety and feasibility of double-target CART-19 and 20 cells to the patients with relapsed and refractory CD19+/CD20+ 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 |
|---|---|---|---|
| Non-hodgkin Lymphoma,B Cell | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CART-19 and 20 cells | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- double-target CART-19 and 20
- description
- Patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of double-target CART-19 and 20 cells. The double-target CART-19 and 20 cells are to be administered on day0.
- interventionNames
- Biological: CART-19 and 20 cells
- Drug: Cyclophosphamide
- Drug: Fludarabine
Primary outcomes (1)
- measure
- safety as assessed by the occurrence of study related adverse events
- timeFrame
- from the date of recieving intravenous CART cells up to one month
- description
- monitor the occurrence of study related adverse events
Secondary outcomes (2)
- measure
- objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 to 75 years old (including 18 and 75) 2. Diagnosed as R/R NHL 3. CD19/CD20 positive confirmed by cell flow cytometry or immunohistochemistry 4. Having at least one measurable lesions 5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 6. Life expectancy no less than 3 months 7. enough main organ function 8. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and 12 months after this study 9. Agreeing to sign the written informed consents Exclusion Criteria: 1. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 12 months 2. Active GVHD 3. History of severe pulmonary dysfunction 4. Active malignant tumor need be treated at the same time 5. Uncontrolled active acute/chronic infection 6. Severe autoimmune diseases or congenital immunodeficiency 7. Untreated active hepatitis 8. HIV-positive, AIDS patients and syphilis infection 9. History of severe allergies to biological products 10. Patients with a history of mental illness 11. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test) 12. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results
References
Publications (0)
Data not yet available
No reference posted for this study.