Clinical trial · Interventional
CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL
A Single-arm, Open-label Phase I Study of CAR-T-19 (Anti CD19 scFv Chimeric Antigen Receptor T) Cells for Patients With CD19-positive Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia Under The Age of 25
NCT05270772CI-TRIAL-00056940unknownPhase 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 phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD19+ Relapse/Refractory B-ALL | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T-19 Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T-19 Cells
- description
- The patients with CD19+ relapse or refractory B-ALL will receive a single infusion of autologous CAR-T-19 cells, with the escalated dose ranging from 0.5×10\^6/kg to 5.0×10\^6/kg CAR+ cells.
- interventionNames
- Biological: CAR-T-19 Cells
Primary outcomes (3)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- up to 2 years
- description
- DLT within 28 days (±3 days) after CAR-T-19 infusion.
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- up to 2 years
- description
- The maximum dose of DLT occurred in ≤1/6 of the subjects within 28 days (±3 days) after CAR-T-19 infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with relapse/refractory B-ALL. * Tumor cells from bone marrow or peripheral blood are measured CD19+ with 3 months before enrollment. * Karnofsky Score ≥ 70 or Lansky Score ≥ 50. * Patients who have a life expectancy of at least 12 weeks. * Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures. Exclusion Criteria: * Patients with extramedullary relapse (EMR). * Patients with genetic diseases, Burkitt lymphoma and leukemia or other malignancies. * Patients positive for any of the following: HbsAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA. * Patients with other uncontrolled infection. * Patients who received anti-CD19 / anti-CD3 therapy, or any other anti-CD19 therapy. * Patients with active Grade II-IV GVHD within 3 months prior to screening. * Tumor cells are detected in cerebrospinal fluid. * Patients who received HSCT within 3 months prior to screening. * Anticipated other clinical trials within 4 weeks before this trial * Pregnant or lactating women. * Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.
References
Publications (0)
Data not yet available
No reference posted for this study.