CD19 CAR T-cell Target Relapsed/Refractory Acute B Cell Leukemia/Lymphoma

Trial details

Who runs it

Zhujiang Hospital

Trial code

NCT05613348

Record updated

18 March 2024

Original description

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.Read full original descriptionShow less

Humanized CAR19T2 T Cell in Children With Refractory/Relapsed B-cell Leukemia/Lymphoma

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.

Inclusion: ≥1 year old and ≤18 years; Patients with relapsed and/or refractory CD19-positive B-cell acute leukemia/lymphoma; 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; 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; Adequate vascular access leukapheresis procedure. Absolute Lymphocyte count (ALC) greater than or equal to 100 cells/μL; 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; Life expectancy of greater than or equal to 3 months; Patients or legal guardians must sign an informed consent.

Exclusion: Prior received any other CAR T cell and tumor vaccine treatment; Patient with a previous history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection; Acute GVHD grade II-IV (Glucksberg criteria) or chronic GVHD requiring systemic treatment within 4 weeks before enrollment; Major non-medicinal surgery within four weeks; Received other clinical trials within four weeks. 10. Women who are pregnant or breastfeeding; 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; 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; Tyrosine Kinase Inhibitor within 1 week and asparaginase within 4 weeks prior to CAR T-cell infusion; In the opinion of the PI, patients are present for any condition, not for enrollment; Patient with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment; 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); Severe psychological disorder or psychiatric illness; Combined with life-threatening severe organ failure; Donor lymphocyte infusions (DLI) and Immunosuppressive therapies within 4 weeks before collection.

ClinicalTrials.gov NCT05613348