Clinical trial · Interventional
Humanized CD19 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With B-cell Malignancies
Treatment of Relapsed or Refractory B-cell Malignancies by Humanized CD19 Chimeric Antigen Receptor (CAR)-Modified T Cells
NCT04008251CI-TRIAL-00039925unknownPhase 1ClinicalTrials.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 single arm, open-label study to evaluate the safety and efficacy of humanized anti-CD19 CAR-T cells 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 |
|---|---|---|---|
| Second generation humanized CAR-T cells | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Second generation humanized CAR-T cells
- description
- Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Genetic: Second generation humanized CAR-T cells
Primary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- 5 years
- description
- 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 (7)
- measure
- One-month remission rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient is pathologically and histologically confirmed as CD19 + B cell tumors, and has no effective treatment options currently, such as chemotherapy; or relapsed after auto-HSCT/allo-HSCT; or patients voluntarily choose CD19 CAR-T cells as a first treatment; 2. B cell hematological malignancies include the following three categories: A. B-cell acute lymphocytic leukemia (B-ALL); B. Indolent B-cell lymphoma (CLL, FL, MZL, LPL); C. Aggressive B-cell lymphoma (DLBCL, BL, MCL); 3. Aged from 14 to 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 themself, or legally authorized representative. Exclusion Criteria: 1. With a history of epilepsy or other central nervous system diseases; 2. Having graft-versus-host reaction, requires the use of immunosuppressants; 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. Using product of gene therapy before; 9. 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); 10. Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial; 11. Patients with HIV-infection; 12. Any situation that may increase the risk of patients or interfere with test results.
References
Publications (2)
- 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
- DERIVEDZhang Y, Zhou F, Wu Z, Li Y, Li C, Du M, Luo W, Kou H, Lu C, Mei H. Timing of Tocilizumab Administration Under the Guidance of IL-6 in CAR-T Therapy for R/R Acute Lymphoblastic Leukemia. Front Immunol. 2022 Jun 21;13:914959. doi: 10.3389/fimmu.2022.914959. eCollection 2022. PMID 35799791