NCT02721407

Anti-CD22 CAR-T Therapy for CD19-refractory or Resistant Lymphoma Patients

A Phase I Study of Anti-CD22:TCRz:4-1BB T-cells in Patient With CD22-Positive Recurrent Lymphoma That is Resistant or Refractory to Prior Anti-CD22:TCRz:CD28 Immunotherapy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD22:TCRz:4-1BB chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating recurrent patients with refractory or resistant lymphoma to anti-CD19:TCRz:CD28 CAR-T cells. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Among the many emerging immunotherapeutic approaches, clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. CARs combine the variable region of an antibody with T-cell signaling moieties to confer T-cell activation with the targeting specificity of an antibody. Thus, CARs are not MHC-restricted so they are not vulnerable to MHC down regulation by tumors. However, defined by the recession of evaluable lesions, the persistence and efficacy of CAR-T cells are still restricted by the "target" selection. Previous clinical studies largely utilized CD19 for the in vivo targeting of CAR-T cells, which preferentially become refractory or resistant due to the heterogeneity of lymphoma. This clinical investigation is to test a hypothesis whether anti-CD22 CAR-T cells work more effective in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells.

Detailed description

Primary Objectives 1. To determine the safety of CD22.CAR-T cells in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells 2. To determine in vivo dynamics and persistency of CD22.CAR-T cells. Secondary Objectives 1. To determine the feasibility of CD22.CAR-T cells in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells 2. To determine in vivo dynamics and persistency of CD22.CAR-T cells. 3. To assess the intratumoral infiltration of CD22.CAR-T cells. 4. To correlate the subsets and differentiation of CD22.CAR-T cells to observed anti-tumor efficacy

Conditions

• Recurrent Adult Diffuse Large Cell Lymphoma
• Recurrent Follicular Lymphoma
• Recurrent Mantle Cell Lymphoma
• Stage III/IV Adult Diffuse Large Cell Lymphoma
• Stage III/IV Follicular Lymphoma
• Stage III/IV Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Retroviral vector-transduced autologous T cells to express CD22-specific CARs

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2016-03-29
• Last updated: 2017-03-10

Locations

1 site across 1 country: China