Clinical trial · Interventional
CAR-T Treatment for Relapse / Refractory Type Safety and Effectiveness of Lymphoma
CAR-T Cell Therapy for Relapsed / Refractory CD19 Positive Clinical Study on the Safety and Effectiveness of Lymphoma
NCT03488160CI-TRIAL-00032437unknownN/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)
The safety and feasibility of CAR-T cells (CD19.CAR-T) targeted at CD19 in the treatment of relapsed / refractory CD19 positive lymphoma were determined, and the proliferation and survival time of CD19.CAR-T cells in patients were determined.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-targeted CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form:injection Dosage:100ml/time Frequency:the first day,the second day Duration:total two times
- interventionNames
- Biological: CD19-targeted CAR-T cells
Primary outcomes (1)
- measure
- Primary Outcome Measure: The overall efficiency
- timeFrame
- [Time Frame: 3 years]
- description
- Complete remission (CR) number+The number of partial response (PR)/Total number of cases being treated
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age is 16 years old, less than 70 years old, sex is not limited, race is not limited; 2. The pathological diagnosis was CD19 positive expression of B type lymphoma relapsed / refractory, meet any one of the following can be diagnosed with relapsed / refractory lymphoma: 1)the standard scheme of standardized treatment of more than 4 courses in 50%, or the condition of tumor size;2) standard treatment of CR, but the recurrence of use the original scheme or the current national consensus recommended second-line treatment can not get CR again;3) the relapse after haematopoietic stem cell transplantation; 3. The patient needs to have a lesion that can be used to detect or evaluate the disease. 4. 0\~1 score of physical status score of the eastern cancer cooperation group (ECOG). 5. At the time of collection of peripheral white blood cell counts over 1 \* 10\^9/L; 6. Expected survival time \> 90 days; 7. Patients have the ability to know and sign informed consent. Exclusion Criteria: 1. Pregnant or lactating women; 2. Uncontrolled infection; 3. HIV infected people, hepatitis B or HCV active stage; 4. Needs patients with long-term immunosuppressive therapy (such as allergies, autoimmune diseases, GVHD, etc.). 5. Combined with active central nervous system malignant tumor invading; 6. Has abnormal coagulation function, and there are patients with serious thrombus. 7. Organ failure (Appendix); A. heart: Grade II and above; B. liver: higher than grade II; C. kidney: second stages of renal insufficiency and above; D. lung: the second grade was slightly hypofunction and above. E. brain: metastatic or active lesion of the central nervous system. 8. Patients who participated in other clinical trials in the past 30 days or in other clinical trials; 9. Researchers believe that patients are not suitable for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.