Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Two-Arm, Single-Center, Open-Label Pilot Study of IL-2 Programmed or IL-7/IL-15 Programmed Anti-CD19:TCRz:CD28 T-cells in Patient With CD19-Positive Lymphoma That is Resistant or Refractory to Chemotherapy
Brief Summary: The goal of this clinical trial is to study how approaches for manufacturing chimeric antigen receptor (CAR)-modified T (CAR-T) cells affect their in vivo persistence and therapeutic efficacy against B lymphoma. 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 activation and contraction program of their mother cells, the persistency and function of CAR-T cells are also restricted by the protocol of manufacturing. Previous clinical studies largely utilized interleukin-2 (IL-2) for the ex vivo expansion of CAR-T cells, which preferentially generate CAR-T cells with characteristics of terminally differentiated effector cells. Our preliminary data indicated that two common gamma chain cytokines, IL-7 and IL-15, can help to selectively expand CAR-T cells with various memory phenotypes. CAR-T Cells prepared under this condition resulted in improved therapeutic efficacy in preclinical animal models. This clinical investigation is to test a hypothesis whether IL-7/IL-15-programmed anti-CD19 CAR-T cells persist longer in lymphoma patients after infusion and whether the persistency of CAR-T cells can lead to improved anti-lymphoma efficacy.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: FBTA05 | Intervention Type: DRUG; Name: FBTA05; Assigned to Arm(s): 1
B: Arm Label: CAR-NK Cell immunotherapy; Type: EXPERIMENTAL; Interventions: Biological: anti-CD19 CAR-NK cells | Intervention Type: BIOLOGICAL; Name: anti-CD19 CAR-NK cells; Assigned to Arm(s): CAR-NK Cell immunotherapy
C: Arm Label: IL-2 programmed CD19.CAR-T cells; Type: EXPERIMENTAL; Interventions: Drug: CD19.CAR-T cells | Arm Label: IL-7/IL-15 programmed CD19.CAR-T cells; Type: EXPERIMENTAL; Interventions: Drug: CD19.CAR-T cells | Intervention Type: DRUG; Name: CD19.CAR-T cells; Assigned to Arm(s): IL-2 programmed CD19.CAR-T cells, IL-7/IL-15 programmed CD19.CAR-T cells
D: Arm Label: HIGH DOSE CHEMOTHERAPY AND ASCT; Type: EXPERIMENTAL; Interventions: Drug: Carmustine, Drug: Etoposide, Drug: Cytarabine, Drug: Melphalan, Biological: Pegfilgrastim, Biological: 19-28z T CELLS, Procedure: Autologous Stem Cell Transplantation | Intervention Type: DRUG; Name: Carmustine; Assigned to Arm(s): HIGH DOSE CHEMOTHERAPY AND ASCT | Intervention Type: DRUG; Name: Etoposide; Assigned to Arm(s): HIGH DOSE CHEMOTHERAPY AND ASCT | Intervention Type: DRUG; Name: Cytarabine; Assigned to Arm(s): HIGH DOSE CHEMOTHERAPY AND ASCT | Intervention Type: DRUG; Name: Melphalan; Assigned to Arm(s): HIGH DOSE CHEMOTHERAPY AND ASCT | Intervention Type: BIOLOGICAL; Name: Pegfilgrastim; Assigned to Arm(s): HIGH DOSE CHEMOTHERAPY AND ASCT | Intervention Type: BIOLOGICAL; Name: 19-28z T CELLS; Assigned to Arm(s): HIGH DOSE CHEMOTHERAPY AND ASCT | Intervention Type: PROCEDURE; Name: Autologous Stem Cell Transplantation; Assigned to Arm(s): HIGH DOSE CHEMOTHERAPY AND ASCT

Answer: C