Clinical trial · Interventional
CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies
A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
NCT05105867CI-TRIAL-00066340unknownEarly Phase 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)
It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.
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 |
|---|---|---|---|
| Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
| Relapsed or Refractory B-cell Non-hodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-CD19 Universal CAR-T Cells injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-CD19 Universal CAR-T Cells injection
- description
- Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion .
- interventionNames
- Biological: Anti-CD19 Universal CAR-T Cells injection
Primary outcomes (1)
- measure
- Dose Limiting Toxicities
- timeFrame
- Up to 4 weeks after CAR-T infusion
- description
- Incidence of dose-limiting toxicities as protocol-defined
Secondary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- At 4,12,24 weeks after CAR-T infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group Performance Status of 0 or 1； 2. Expected survival time ≥12 weeks; 3. Adequate hematological, renal and liver function; 4. Subjects understand and voluntarily sign the informed consent form. Key Exclusion Criteria: 1. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ; 2. Cyclophosphamide or fludarabine is contraindicated for subjects ; 3. Active central nervous system (CNS) involvement by malignancy； 4. Active infection.
References
Publications (0)
Data not yet available
No reference posted for this study.