NCT02903810

Combination Transfer of αCD19-TCRz-41BB and αCD22-TCRz-41BB CAR-T Cells for B-cell Hematologic Malignancy

A Phase I/II Study of Combination Transfer of αCD19-TCRz-41BB and αCD22-TCRz-41BB Chimeric Antigen Receptor T-Cells in Patients With Refractory or Recurrent CD19/22+ B-lineage Leukemia/Lymphoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Clinical study of CD19 CAR-T in the treatment of blood and lymphatic system tumor has been achieved a breakthrough. The main solution in clinical research is to use CD19 CAR-T infusion alone. Because of the heterogeneity of the tumor, the patient often carries tumor cells with CD19 deficient but other positive target antigens (such as CD22). Specifically removal of CD19 positive tumor cells in CAR-T treatment, CD19 negative tumor cells or tumor cells which carry other target antigens would amplify with extra free space released at the same time, resulting in the relapse of tumors of heterogeneities. In order to effectively control the recurrence, CAR-T treatment scheme specific for several target antigens was presented and verified. However treatment with the sequential infusion of different target specific CAR-T cells, the window period between two times infusions may be the opportunity for the tumor recurrence of heterogeneity; and bispecific CAR-T has also been reported only one CAR can be fully functioned. In order to avoid these problems, this topic puts forward for the first time in the international with a treatment scheme of an equal amount of infusion of CD19-41BB and CD22-41BB two Car-T in the treatment of refractory hematologic malignancies. We expect the treatment is more effective in eliminating tumor burden, and also can inhibit the recurrence of tumor heterogeneity at the same time.

Detailed description

To determine: Primary Outcome Measure: * Safety (incidence of adverse events defined as dose-limited toxicity) Secondary Outcome Measures: * Survival of CAR T cells in circulation measured by flow cytometry and qPCR * Overall complete remission rate * Tissue infiltration of transferred CAR-T cells * In vitro killing potential of infiltrated CAR-T cells * Phenotype of infused CAR-T cells

Conditions

• Hematopoietic/Lymphoid Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Mixed CAR-T Transfer	All subjects will be infused with αCD19-TCRz-41BB and αCD22-TCRz-41BB CAR-T cells in equal number

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2016-09-16
• Last updated: 2016-10-12

Locations

1 site across 1 country: China