Clinical trial · Interventional
A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia
A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.
- 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)
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.
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 |
|---|---|---|---|
| ICAR19 CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICAR19 CAR-T cells
- description
- Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 CAR-T cells and the investigators will determine the safety and therapeutic effects of these cells.
- interventionNames
- Biological: ICAR19 CAR-T cells
Primary outcomes (1)
- measure
- Measure the safety of ICAR19 CAR-T cells
- timeFrame
- 2 years
- description
- To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: CD19 positive leukemia and lymphoma，relapsed and/or refractory： * survival\>12 weeks; * FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin; * LVEF≥50%; * Creatinine\<2.5mg/dl; * Bilirubin\<2.5mg/dl; * ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 x normal; * At least 7 days after last chemotherapy; * provide with informed consent. Exclusion Criteria: * Active clinically significant CNS dysfunction * Pregnant or breast-feeding women. * Uncontrolled active infection including hepatitis B or C. * HIV positive. * Use of systemic steroids within 72 hours. * Allogeneic lymphocyte treatments within recent 6 months. * Any uncontrolled active medical disorder.
References
Publications (0)
Data not yet available