Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
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
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.
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
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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