Clinical trial · Interventional
CD19 CAR T-cell Target Relapsed/Refractory Acute B Cell Leukemia/Lymphoma
Humanized CAR19T2 T Cell in Children With Refractory/Relapsed B-cell Leukemia/Lymphoma
NCT05613348CI-TRIAL-00075110CAR19T2withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The company failed to provide corresponding CART services.
Summary
Brief summary (as posted)
This study aims to evaluate the safety and efficacy of humanized Anti-CD19 Chimeric Antigen Receptor-T cell (CAR19T2 T cell) in children with refractory/relapsed B-cell acute lymphoblastic leukemia/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 |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-Cell Lymphoma, Unspecified | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CAR T-Cell(CAT19T2) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- humanized CAR19T2 T cell to B-cell acute lymphoblastic leukemia/lymphoma
- description
- Patients received fludarabine and cyclophosphamide (Flu/Cy) for lymphodepletion (Cy at 300-500 mg/m2/dose for four days and Flu at 20-30 mg/m2/dose for two days) before CAR19T2 T cells administration. This CAR19T2 T cell will be infused over 30 minutes on days Day 0.
- interventionNames
- Biological: CD19 CAR T-Cell(CAT19T2)
Primary outcomes (3)
- measure
- Overall response rate
- timeFrame
- 3 months
- description
- A total number of patients achieved a Complete response (CR) or CR with incomplete blood count recovery (CRi) on Day 28 and three months by an independent review committee(IRC) assessment, as evaluated by peripheral blood, bone marrow, central nervous system (CNS) symptoms, physical exam (PE), and cerebrospinal fluid(CSF).
- measure
- The maximum tolerated dose(MTD) of CAR19T2 T cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥1 year old and ≤18 years. 2. Patients with relapsed and/or refractory CD19-positive B-cell acute leukemia/lymphoma. 3. Leukemia/lymphoma relapsed after allogeneic hematopoietic stem cell transplantation within four weeks, all immunosuppressive agents were stopped for at least four weeks, and no active graft-versus-host disease(GVHD) was detonated. 4. Lansky play (≤16 years old) scale ≥60% or Karnofsky (\>16 years old) score ≥60% and Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory to assess the performance score. 5. Adequate vascular access leukapheresis procedure. Absolute Lymphocyte count (ALC) greater than or equal to 100 cells/μL. 6. Adequate renal, hepatic, pulmonary, and cardiac function is defined as the following: * Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 5 upper limit of normal (ULN), Total bilirubin ≤2 x ULN. * A serum creatinine based on age/gender as follows: 1 to \< 2 years: maximum serum creatinine 0.6 mg/dL (both male and female);2 to \< 6 years: maximum serum creatinine 0.8 mg/dL (both male and female); 6 to \< 10 years: maximum serum creatinine 1 mg/dL (both male and female); 10 to \< 13 years: maximum serum creatinine 1.2 mg/dL (both male and female); 13 to \< 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female); \>=16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female). * Baseline oxygen saturation \> 92% on room air. * Echocardiogram or left ventricular ejection fraction (LVEF) greater than or equal to 45% confirmed by echocardiogram, no evidence of pericardial effusion (except trace or physiological), and no clinically significant arrhythmias. 7. Life expectancy of greater than or equal to 3 months. 8. Patients or legal guardians must sign an informed consent. Exclusion Criteria: 1. Prior received any other CAR T cell and tumor vaccine treatment. 2. Patient with a previous history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. 3. Patient with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment. 4. Acute GVHD grade II-IV (Glucksberg criteria) or chronic GVHD requiring systemic treatment within 4 weeks before enrollment. 5. History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, etc. (Except for CNS involvement of underlying hematological malignancy) 6. Severe psychological disorder or psychiatric illness. 7. Combined with life-threatening severe organ failure. 8. Major non-medicinal surgery within four weeks. 9. Received other clinical trials within four weeks. 10. Women who are pregnant or breastfeeding. 11\. The following drugs patients must be stopped prior to leukapheresis: * Tyrosine Kinase Inhibitor (TKI) must be discontinued more than or equal to 3 days before collection. * Salvage chemotherapy must be stopped \> 2 weeks and intrathecal chemotherapy in the 7 days prior to collection. * Systemic steroid therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone in the 7 days before collection. * Donor lymphocyte infusions (DLI) and Immunosuppressive therapies within 4 weeks before collection. * Received clofarabine or cladribine within 3 months prior to collection. * Receive blinatumomab within 4 weeks, inotuzumab ozogamicin, and rituximab within 4 months, and alemtuzumab within 6 months before collection. 12\. Tyrosine Kinase Inhibitor within 1 week and asparaginase within 4 weeks prior to CAR T-cell infusion. 13\. In the opinion of the PI, patients are present for any condition, not for enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.