Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-02: A Phase 1/2 Feasibility and Safety Study of CD19-CAR T Cell Immunotherapy for CD19+ Leukemia
Brief Summary: Patients with relapsed or refractory leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia. This is a phase 1/2 study designed to determine the maximum tolerated dose of the CAR+ T cells as well as to determine the efficacy. The phase 1 cohort is restricted to those patients who have already had an allogeneic hematopoietic cell transplant (HCT). The phase 2 is open to all patients regardless of having a history of HCT.


Options:
A: Arm Label: Phase 1 - Cohort 1A; Type: EXPERIMENTAL; Interventions: Biological: Patient Derived CD19 specific CAR T cells also expressing an EGFRt | Arm Label: Phase 1 - Cohort 1B; Type: EXPERIMENTAL; Interventions: Biological: Patient Derived CD19 specific CAR T cells also expressing an EGFRt | Arm Label: Phase 1 - Cohort 1C; Type: EXPERIMENTAL; Interventions: Biological: Patient Derived CD19 specific CAR T cells also expressing an EGFRt | Arm Label: Phase 1 - Cohort 1D; Type: EXPERIMENTAL; Interventions: Biological: Patient Derived CD19 specific CAR T cells also expressing an EGFRt | Arm Label: Phase 1 - Cohort 1F1; Type: EXPERIMENTAL; Interventions: Biological: Patient Derived CD19 specific CAR T cells also expressing an EGFRt | Arm Label: Phase 1 - Cohort 1F2; Type: EXPERIMENTAL; Interventions: Biological: Patient Derived CD19 specific CAR T cells also expressing an EGFRt | Arm Label: Phase 2; Type: EXPERIMENTAL; Interventions: Biological: Patient Derived CD19 specific CAR T cells also expressing an EGFRt | Intervention Type: BIOLOGICAL; Name: Patient Derived CD19 specific CAR T cells also expressing an EGFRt; Assigned to Arm(s): Phase 1 - Cohort 1A, Phase 1 - Cohort 1B, Phase 1 - Cohort 1C, Phase 1 - Cohort 1D, Phase 1 - Cohort 1F1, Phase 1 - Cohort 1F2, Phase 2
B: Arm Label: 1x10^9-1x10^10+ high dose Interleukin-2; Type: EXPERIMENTAL; Interventions: Drug: Fludarabine, Drug: Cyclophosphamide, Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL, Drug: Aldesleukin | Arm Label: 1x10^9-1x10^10 + high dose Retreat; Type: EXPERIMENTAL; Interventions: Drug: Fludarabine, Drug: Cyclophosphamide, Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL, Drug: Aldesleukin | Arm Label: 0.5x10^7 cells/kg; Type: EXPERIMENTAL; Interventions: Drug: Fludarabine, Drug: Cyclophosphamide, Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL | Arm Label: 2.5x10^6 cells/kg; Type: EXPERIMENTAL; Interventions: Drug: Fludarabine, Drug: Cyclophosphamide, Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL | Arm Label: 1.0x10^6 cells/kg; Type: EXPERIMENTAL; Interventions: Drug: Fludarabine, Drug: Cyclophosphamide, Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL | Arm Label: 1.0x10^6 cells/kg (Reduced chemo); Type: EXPERIMENTAL; Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL, Drug: Fludarabine, Drug: Cyclophosphamide | Arm Label: 2.0x10^6 cells/kg (Reduced chemo); Type: EXPERIMENTAL; Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL, Drug: Fludarabine, Drug: Cyclophosphamide | Arm Label: 6.0x10^6 cells/kg (Reduced chemo); Type: EXPERIMENTAL; Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL, Drug: Fludarabine, Drug: Cyclophosphamide | Arm Label: 2.0x10^6 cells/kg (Moderate chemo); Type: EXPERIMENTAL; Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL, Drug: Fludarabine, Drug: Cyclophosphamide | Arm Label: 2.0x10^6 cells/kg (9-12 days culture); Type: EXPERIMENTAL; Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL, Drug: Fludarabine, Drug: Cyclophosphamide | Intervention Type: DRUG; Name: Fludarabine; Assigned to Arm(s): 0.5x10^7 cells/kg, 1.0x10^6 cells/kg, 1x10^9-1x10^10 + high dose Retreat, 1x10^9-1x10^10+ high dose Interleukin-2, 2.5x10^6 cells/kg | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): 0.5x10^7 cells/kg, 1.0x10^6 cells/kg, 1x10^9-1x10^10 + high dose Retreat, 1x10^9-1x10^10+ high dose Interleukin-2, 2.5x10^6 cells/kg | Intervention Type: BIOLOGICAL; Name: Anti-cluster of differentiation 19 (CD19)-CAR PBL; Assigned to Arm(s): 0.5x10^7 cells/kg, 1.0x10^6 cells/kg, 1.0x10^6 cells/kg (Reduced chemo), 1x10^9-1x10^10 + high dose Retreat, 1x10^9-1x10^10+ high dose Interleukin-2, 2.0x10^6 cells/kg (9-12 days culture), 2.0x10^6 cells/kg (Moderate chemo), 2.0x10^6 cells/kg (Reduced chemo), 2.5x10^6 cells/kg, 6.0x10^6 cells/kg (Reduced chemo) | Intervention Type: DRUG; Name: Aldesleukin; Assigned to Arm(s): 1x10^9-1x10^10 + high dose Retreat, 1x10^9-1x10^10+ high dose Interleukin-2 | Intervention Type: DRUG; Name: Fludarabine; Assigned to Arm(s): 1.0x10^6 cells/kg (Reduced chemo), 2.0x10^6 cells/kg (9-12 days culture), 2.0x10^6 cells/kg (Moderate chemo), 2.0x10^6 cells/kg (Reduced chemo), 6.0x10^6 cells/kg (Reduced chemo) | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): 1.0x10^6 cells/kg (Reduced chemo), 2.0x10^6 cells/kg (9-12 days culture), 2.0x10^6 cells/kg (Moderate chemo), 2.0x10^6 cells/kg (Reduced chemo), 6.0x10^6 cells/kg (Reduced chemo)
C: Arm Label: Treatment (T cell therapy); Type: EXPERIMENTAL; Interventions: Biological: allogeneic cytomegalovirus-specific cytotoxic T lymphocytes | Intervention Type: BIOLOGICAL; Name: allogeneic cytomegalovirus-specific cytotoxic T lymphocytes; Assigned to Arm(s): Treatment (T cell therapy)
D: Arm Label: Treatment (CAR transduced CB-NK cells, chemotherapy, ASCT); Type: EXPERIMENTAL; Interventions: Procedure: Autologous Hematopoietic Stem Cell Transplantation, Drug: Carmustine, Drug: Cytarabine, Drug: Etoposide, Biological: Filgrastim, Drug: Melphalan, Biological: Rituximab, Biological: Umbilical Cord Blood-derived Natural Killer Cells | Intervention Type: PROCEDURE; Name: Autologous Hematopoietic Stem Cell Transplantation; Assigned to Arm(s): Treatment (CAR transduced CB-NK cells, chemotherapy, ASCT) | Intervention Type: DRUG; Name: Carmustine; Assigned to Arm(s): Treatment (CAR transduced CB-NK cells, chemotherapy, ASCT) | Intervention Type: DRUG; Name: Cytarabine; Assigned to Arm(s): Treatment (CAR transduced CB-NK cells, chemotherapy, ASCT) | Intervention Type: DRUG; Name: Etoposide; Assigned to Arm(s): Treatment (CAR transduced CB-NK cells, chemotherapy, ASCT) | Intervention Type: BIOLOGICAL; Name: Filgrastim; Assigned to Arm(s): Treatment (CAR transduced CB-NK cells, chemotherapy, ASCT) | Intervention Type: DRUG; Name: Melphalan; Assigned to Arm(s): Treatment (CAR transduced CB-NK cells, chemotherapy, ASCT) | Intervention Type: BIOLOGICAL; Name: Rituximab; Assigned to Arm(s): Treatment (CAR transduced CB-NK cells, chemotherapy, ASCT) | Intervention Type: BIOLOGICAL; Name: Umbilical Cord Blood-derived Natural Killer Cells; Assigned to Arm(s): Treatment (CAR transduced CB-NK cells, chemotherapy, ASCT)

Answer: A