Clinical trial · Interventional
A Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies
A Prospective, Multicenter, Single-Arm Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies
- 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)
Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with refractory /relapsed B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drugs and anti-CD19 CAR transduced T cells | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-CD19 CAR transduced T cells
- description
- Patients will receive a lymphodepleting preconditioning regimen with Fludarabine and Cyclophosphamide followed by anti-CD19 CAR-transduced T cells.
- interventionNames
- Combination Product: Drugs and anti-CD19 CAR transduced T cells
Primary outcomes (2)
- measure
- Number of participants with Adverse Events
- timeFrame
- 24 months
- description
- To evaluate the safety and feasibility of the administration of anti-CD19 CAR transduced T cells in patients with refractory /relapsed CD19+ B cell malignancies.
- measure
- Number of participants with clinical responses
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have a CD19+ B cell malignancy,including relapsed or refractory B cell leukemia and/or B cell lymphoma; 2. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis; 3. Patients with history of allogeneic stem cell transplantation are eligible, providing 6 months had elapsed from SCT, they have no evidence of active graft-versus-host disease (GVHD) and no longer taking immunosuppressive agents during the treatment; 4. Able to understand and sign the Informed Consent Document; 5. There is no obvious dysfunctions in heart , liver, lung, kidney, and performance status with ECOG \< 2; 6. Life expectancy:More than 3 months for leukemia and more than 6 months for lymphoma. Exclusion Criteria: 1. Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression; 2. Patients that have active hemolytic anemia; 3. Patients who have uncontrollable infectious diseases within 2 weeks before enrollment; 4. Patients with human immunodeficiency virus (HIV) antibody seropositive; 5. Active infection of Hepatitis B virus and / or hepatitis C virus; 6. Patients with any residual intracranial implants; 7. Coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; 8. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease); 9. Concurrent opportunistic infections; 10. Concurrent systemic steroid therapy; 11. History of severe immediate hypersensitivity reaction to any of the agents used in this study; 12. Women of child-bearing potential who are pregnant or breastfeeding; 13. Patients with cardiac atrial or cardiac ventricular lymphoma involvement; 14. Other anti-neoplastic investigational agents currently or within 30 days prior to start of the treatment; 15. Psychiatric patients; 16. Previous treatment with any gene therapy products.
References
Publications (0)
Data not yet available