NCT06879262

Clinical Study of Novel TLR2-Containing CAR-T Cells Targeting CD19 and CD22 for Relapsed/Refractory B-ALL and NHL

Clinical Study of Novel TLR2-Containing CAR-T Cells Targeting CD19 and CD22 for Refractory/Relapsed B-Cell Acute Lymphoblastic Leukemia and Non-Hodgkin Lymphoma

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of CAR1922T2 T-cell therapy in participants with relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma. Participants will receive a single infusion of CAR1922T2 T-cells and complete follow-ups over the next three years.

Detailed description

Acute lymphoblastic leukemia (ALL) is a hematological malignancy characterized by the clonal proliferation of precursor lymphoid cells, with a cure rate of only 30-40% in adults through standardized chemotherapy. Non-Hodgkin's lymphoma (NHL) is a highly heterogeneous group of lymphatic and reticular neoplasms derived from the clonal malignant proliferation of lymphoid cells, with 30-40% of patients developing into refractory disease or relapsing after initial treatment. Although CAR-T cell therapy targeting CD19 has made significant progress in the treatment of patients with refractory/relapsed B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma, more than 50% of patients treated with CAR19 experience disease progression, which is related to the loss of CD19 on the cell surface. Therefore, our research team has developed a dual-specific CAR-T cell targeting both CD19 and CD22 to enhance the tumor-killing ability of CAR-T cells. This clinical trial aims to evaluate the effectiveness and safety of CAR-T cell therapy targeting CD19 and CD22 (CAR1922T2 T cells) in participants with refractory/relapsed B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma. After treatment with CAR1922T2 T cells, the effectiveness and safety of CAR1922T2 T-cell therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma will be assessed through clinical symptom evaluation, quality of life assessment, biomarker testing, laboratory testing, imaging evaluation, adverse event monitoring, and follow-up surveys.

Conditions

• R/R NHL

Interventions

Type	Name	Description
BIOLOGICAL	CAR1922T2 T cells（Targeting CD19 and CD22 with CAR-T cells）	Administer a single infusion of CAR1922T2 T cells to this group of patients following fludarabine plus cyclophosphamide (F+C) lymphodepletion

Timeline

• Start date: 2026-02-15
• Primary completion: 2028-02-28
• Completion: 2029-02-28
• First posted: 2025-03-17
• Last updated: 2026-01-06