Senl_1904A and Senl_1904B Chimeric Antigen Receptor ?CAR? T-Cell in the Treatment of r/ r Acute B Lymphocytic Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Lymphocytic Leukemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 3 years and 65 years
- Gender
- Both males and females
Description
The CARs consist of an anti-CD19 single-chain variable fragment?scFv? that was derived from the FMC63 mouse hybridoma, a portion of the human CD137?4-1BB? molecule, and the intracellular component of the human CD3? molecule. Autologous T cells will be gene engineered with the CAR gene using a lentiv...
The CARs consist of an anti-CD19 single-chain variable fragment?scFv? that was derived from the FMC63 mouse hybridoma, a portion of the human CD137?4-1BB? molecule, and the intracellular component of the human CD3? molecule. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Compared to Senl_1904A, Senl_1904B has a higher and more stable transfection efficiency and secretes lower levels of cytokines in functional assays, thus having the potential to significantly reduce the incidence of serious adverse events while ensuring the same complete response rate. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for one month after infusion for adverse reactions and efficacy.
Tracking Information
- NCT #
- NCT03840317
- Collaborators
- Hebei Yanda Ludaopei Hospital
- Investigators
- Principal Investigator: Peihua Lu, PhD&MD Hebei Yanda Ludaopei Hospital
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