Clinical trial · Interventional
CD19-CAR-T2 Cells for CD19 Positive B Cell Malignancies
CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Relapsed/Refractory B Cell Leukemia/Lymphoma
NCT04605666CI-TRIAL-00079960completedPhase 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)
Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell Non Hodgkin Lymphoma (B-NHL).
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 |
|---|---|---|---|
| B Cell Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| B Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-CAR-T2 Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T group
- interventionNames
- Biological: CD19-CAR-T2 Cells
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 3 months
- description
- Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
Secondary outcomes (5)
- measure
- ORR
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with relapsed and/or refractory CD19+ B-cell leukemia or lymphoma * Eastern Cooperative Oncology Group (ECOG) performance status \<2 * ALT/ AST \<3 x normal * Bilirubin \< 2.0 mg/dl * Creatinine \< 2.5 mg/dl and less than 2.5x normal for age * LVEF\< 45% * Accept white blood cell collection * Provide informed consent Exclusion Criteria: * Previous treatment with investigational gene or cell therapy medicine products * Active hepatitis B , hepatitis C or HIV infection * Uncontrolled active infection * Presence of grade 2-4 acute or extensive chronic GVHD * Any uncontrolled active medical disorder that would preclude participation as outlined. * Received non-diagnostic purposes major surgery within the past 4 weeks * Participated in any other clinical study within the past 4 weeks * Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist. * Pregnancy or breast-feeding women * Use of prohibited drugs: * Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to CD19-CAR-T2 Cells infusion * Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 4 weeks prior to CD19-CAR-T2 Cells infusion * GVHD therapies: Any drug used for GVHD must be stopped \> 4 weeks prior to CD19-CAR-T2 Cells infusion * Any situation that may increase the risk of the test or interfere with the test results
References
Publications (1)
- DERIVEDHe B, Lin R, Xu N, Qin L, Wang Z, Wang Q, Li X, Wei X, Wei Y, Tang Z, Fan Z, Huang F, Liu X, Sun J, Xuan L, Li P, Zhou H, Liu Q. Efficacy and safety of third-generation CD19-CAR T cells incorporating CD28 and TLR2 intracellular domains for B-cell malignancies with central nervous system involvement: results of a pivotal trial. J Transl Med. 2025 May 27;23(1):594. doi: 10.1186/s12967-025-06608-x. PMID 40426201