NCT03840317

Senl_1904A and Senl_1904B Chimeric Antigen Receptor （CAR） T-Cell in the Treatment of r/ r Acute B Lymphocytic Leukemia

Randomized, Parallel-arm, Controlled Trial of Senl_1904A and Senl_1904B Autologous CAR-T Cell Injections in the Treatment of Relapsed and Refractory Acute B Lymphocytic Leukemia(r/r B-ALL)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 3 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open, two arms, mask phase I clinical study to evaluate efficacy and safety of two different chimeric antigen receptor T cell immunotherapies (Senl\_1904A and Senl\_1904B) targeting cluster of differentiation antigen 19 （CD19） in the treatment of Acute lymphocytic Leukemia. A total of 20 patients are planned to be enrolled following up half a year.

Detailed 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 CD3ζ 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.

Conditions

• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Autologous CD19-targeting CAR T cells	Autologous CD19-targeting CAR T cells

Timeline

• Start date: 2019-01-02
• Primary completion: 2021-09-01
• Completion: 2022-01-31
• First posted: 2019-02-15
• Last updated: 2021-01-20

Locations

1 site across 1 country: China