CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

Overview

This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2024

Detailed Description

CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Interventions

  • Biological: CD19 CAR-T cells
    • CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Arms, Groups and Cohorts

  • Experimental: Arm 1
    • CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.

Clinical Trial Outcome Measures

Primary Measures

  • The complete remission (CR) rate
    • Time Frame: Participants will be followed for the duration of the treatment, an expected average of 12 months
    • The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined

Participating in This Clinical Trial

Inclusion Criteria

1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia 2. ALT/ AST 《 3x normal 3. Creatinine 《 3x normal 4. Age:10-60. 5. Signed informed consent Exclusion Criteria:

1. Active hepatitis B , hepatitis C or HIV infection 2. Uncontrolled active infection 3. Pregnancy or breast-feeding women 4. Survival less than four weeks

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
  • Collaborator
    • The First Affiliated Hospital of Soochow University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sheng-Li Xue, Ph.D, Principal Investigator, The First Affiliated Hospital of Soochow University
  • Overall Contact(s)
    • Sheng-Li Xue, MD, 86-13328008851, slxue@suda.edu.cn

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