Clinical trial · Interventional
CD19-directed CAR T Cells Therapy in Relapsed/Refractory B Cell Malignancy
CD19-directed Chimeric Antigen Receptor T Cells Therapy in Relapsed/Refractory B Cell Malignancy
- 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)
Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In this clinical trial, the investigators aim to assess the safety and efficacy of administering T cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-directed CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T cells
- description
- Autologous 2nd generation CD19-directed CAR-T cells
- interventionNames
- Biological: CD19-directed CAR-T cells
Primary outcomes (1)
- measure
- Occurrence of study related adverse events
- timeFrame
- 2 years
- description
- defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly,likely,or definitely related to the study.
Secondary outcomes (4)
- measure
- Response rates to CAR-T cells
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with CD19+ leukemia or lymphoma, meeting the following criteria: * At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy) * Less than 1 year between last chemotherapy and progression * Not eligible or appropriate for allo-HSCT * To be aged 6 to 85 years * Estimated survival of ≥ 6 months, but ≤ 2 years * ECOG score ≤2 * Relapse after auto-HSCT * Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time * Voluntary participation in the clinical trials and sign the informed consent Exclusion Criteria: * History of epilepsy or other CNS disease * Patients have GVHD, which needs treatment with immunosuppressive agents * Patients with prolonged QT interval or severe heart disease * Patients in pregnancy or breast-feeding period * Uncontrolled active infection * Active hepatitis B or hepatitis C infection * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary * Previously treatment with any gene therapy products * Feasibility assessment during screening demonstrates \<20% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation * ALT /AST\>3 x normal value; Creatinine\> 2.5 mg/dl; Bilirubin \>2.0 mg/dl * Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial * HIV infection * Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation
References
Publications (1)
- DERIVEDHou M, Zhang W, Qi Z, Li G, Mei H, Qi S, Jin R, Zhao Y, Tang X, Xiu B, Chen X, Zhao Y, Hu C, Qian C, Li X, Xu Z, Chen Y, Wu C, Wang B, Yan L, Li D, Huang Y, Liang R, Wang A, Liu J, Wang W, Li B, Long J, Li P, Liang A, Liu Q, Yang J. Timosaponin AIII enhances CAR-T cell potency and prevents relapse through impairing CAR-Tregs. Nat Commun. 2026 Mar 31;17(1):3045. doi: 10.1038/s41467-026-70867-5. PMID 41916982