Clinical trial · Interventional
Anti-CD19 CAR-T Therapy Bridging to HSCT for CD19+ B-Cell Malignancies
A Phase 1/2 Study Evaluating the Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-Modified T Cell (CAR-T) Therapy Bridging to Hematological Stem Cell Transplantation (HSCT) for Relapsed/Refractory CD19+ B-Cell Malignancies
NCT03366350CI-TRIAL-00038563unknownPhase 1 / Phase 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)
This is the second stage of the previous anti-CD19 CAR-T therapy (NCT02965092). The study aims to evaluate the safety and efficacy of consolidative allo-HSCT following CAR-T therapy in patients with relapsed or refractory B cell Malignancies.
Conditions
Conditions (2)
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 Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| B Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic hematological stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Consolidative allo-HSCT following CAR-T therapy
- description
- Patients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions.
- interventionNames
- Procedure: Allogeneic hematological stem cell transplantation
Primary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- 5 years
- description
- To evaluate the safety of anti-CD19 CAR-T therapy bridging to allo-HSCT. Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient is pathologically and histologically confirmed as CD19 + B cell malignancies, and has achieved MRD-negative CR through CAR-T therapy (NCT02965092); 2. B cell hematological malignancies include the following three categories: * B-cell acute lymphocytic leukemia (B-ALL); * Indolent B-cell lymphoma (CLL, FL, MZL, LPL); * Aggressive B-cell lymphoma (DLBCL, BL, MCL); 3. \< 70 years old; 4. Expected survival time \> 6 months; 5. Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit; 6. Voluntarily participate in this experiment and sign informed consent by themselves, or legally authorized representative. Exclusion Criteria: 1. With a history of epilepsy or other central nervous system diseases; 2. Previous allogeneic hematopoietic stem cell transplantation; 3. The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System); 4. Pregnant or lactating women (safety of this therapy for the unborn child is unknown); 5. Not curable active infection; 6. Patients with active hepatitis B or hepatitis C virus infection; 7. Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently); 8. Creatinine\> 2.5 mg / dl (221.0 umol/L); ALT / AST\> 3 X the normal amount; Bilirubin\> 2.0 mg / dl (34.2 umol/L); 9. Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial; 10. Patients with HIV-infection; 11. Any situation that may increase the risk of patients or interfere with test results.
References
Publications (1)
- DERIVEDDu M, Mayombo RTM, Liu J, Zhang Y, Liao D, Hu Y, Mei H. The impact of obesity and its related underlying diseases on cytokine release syndrome and the efficacy of CAR-T therapy in treating B-cell malignancies. Ann Hematol. 2025 Mar;104(3):1887-1895. doi: 10.1007/s00277-025-06338-6. Epub 2025 Apr 8. PMID 40195173