Clinical trial · Interventional
Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
NCT03258047CI-TRIAL-00037079unknownPhase 2ClinicalTrials.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)
It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients. Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.
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 Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T treatment
- description
- In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated
- interventionNames
- Combination Product: CAR-T
Primary outcomes (1)
- measure
- complete remission rate
- timeFrame
- every 3 months until 20 months after the last patient's enrollment
- description
- complete remission rate after treated by CAR-T therapy
Secondary outcomes (4)
- measure
- progression free survival
- timeFrame
- from the day of treatment to the date of first documented progression,up to 20 months after the last patient's enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age≥18 years, male or female; 2. Karnofsky≥60%; 3. B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years). 4. Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons. 5. Patients have had more than 2 combined chemotherapy regimens; 6. Creatinin \<2.5mg/dL;ALT/AST level \<3 times of the maximum of normal range; bilirubin\<3mg/dL; 7. Proper venous condition for leukapheresis, no contraindication for leukapheresis; 8. Patient that could understand and is willing to sign the written consent; 9. Fertile female patient should be willing to take contraceptive measures. 10. Patient that is willing to follow up till at least 2 months after T cell re-transfusion. Exclusion Criteria: 1. Patients who need ≥15mg prednisone daily due to any cause; 2. Patients with autoimmune disease and need immunosuppressor treatment; 3. Serum creatinin\>2.5 mg/dL;serum AST \>5 times of normal maximum; bilirubin \>3 mg/Dl; 4. FEV1\<2 L,diffusion capacity for carbon monoxide of lung (DLCO) \<40%; 5. Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction\<35%; 6. Patients with HIV infection, active Hepatitis B or Hepatitis C infection; 7. Patients that have previously received gene therapy of any kind; 8. Obvious clinical encephalopathy or novel neuron function damage; 9. Patients with active infection; 10. Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment; 11. Patients who had allergic history to agents of the similar structure as CAR-T;
References
Publications (0)
Data not yet available
No reference posted for this study.