Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Subjects With Relapsed/Refractory Large B-Cell Lymphoma
Brief Summary: The primary objectives of this study are:

Phase 1: To evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2

Phase 2: To evaluate the efficacy of axicabtagene ciloleucel and utomilumab as measured by complete response rate in participants with refractory large B-cell lymphoma


Options:
A: Arm Label: LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only; Type: EXPERIMENTAL; Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells | Arm Label: LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells; Type: EXPERIMENTAL; Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells, Drug: Cyclophosphamide, Drug: Fludarabine | Arm Label: LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells; Type: EXPERIMENTAL; Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells, Drug: Cyclophosphamide, Drug: Fludarabine | Arm Label: LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only; Type: EXPERIMENTAL; Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells | Arm Label: LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells; Type: EXPERIMENTAL; Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells, Drug: Cyclophosphamide, Drug: Fludarabine | Arm Label: LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only; Type: EXPERIMENTAL; Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells | Intervention Type: BIOLOGICAL; Name: Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells; Assigned to Arm(s): LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only, LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells, LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells, LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only, LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells, LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells, LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells, LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells | Intervention Type: DRUG; Name: Fludarabine; Assigned to Arm(s): LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells, LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells, LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells
B: Arm Label: Pts with B Cell Acute Lymphoblastic Leukemia; Type: EXPERIMENTAL; Interventions: Biological: gene-modified T cells targeted | Intervention Type: BIOLOGICAL; Name: gene-modified T cells targeted; Assigned to Arm(s): Pts with B Cell Acute Lymphoblastic Leukemia
C: 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)
D: Arm Label: Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg; Type: EXPERIMENTAL; Interventions: Drug: Cyclophosphamide, Drug: Fludarabine, Biological: Axicabtagene Ciloleucel, Biological: Utomilumab | Arm Label: Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg; Type: EXPERIMENTAL; Interventions: Drug: Cyclophosphamide, Drug: Fludarabine, Biological: Axicabtagene Ciloleucel, Biological: Utomilumab | Arm Label: Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg; Type: EXPERIMENTAL; Interventions: Drug: Cyclophosphamide, Drug: Fludarabine, Biological: Axicabtagene Ciloleucel, Biological: Utomilumab | Arm Label: Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg; Type: EXPERIMENTAL; Interventions: Drug: Cyclophosphamide, Drug: Fludarabine, Biological: Axicabtagene Ciloleucel, Biological: Utomilumab | Arm Label: Phase 1: Cohort 5: Axicabtagene Ciloleucel + Utomilumab 400 mg; Type: EXPERIMENTAL; Interventions: Drug: Cyclophosphamide, Drug: Fludarabine, Biological: Axicabtagene Ciloleucel, Biological: Utomilumab | Arm Label: Phase 2: Axicabtagene Ciloleucel + Utomilumab; Type: EXPERIMENTAL; Interventions: Drug: Cyclophosphamide, Drug: Fludarabine, Biological: Axicabtagene Ciloleucel, Biological: Utomilumab | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg, Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg, Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg, Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg, Phase 1: Cohort 5: Axicabtagene Ciloleucel + Utomilumab 400 mg, Phase 2: Axicabtagene Ciloleucel + Utomilumab | Intervention Type: DRUG; Name: Fludarabine; Assigned to Arm(s): Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg, Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg, Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg, Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg, Phase 1: Cohort 5: Axicabtagene Ciloleucel + Utomilumab 400 mg, Phase 2: Axicabtagene Ciloleucel + Utomilumab | Intervention Type: BIOLOGICAL; Name: Axicabtagene Ciloleucel; Assigned to Arm(s): Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg, Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg, Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg, Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg, Phase 1: Cohort 5: Axicabtagene Ciloleucel + Utomilumab 400 mg, Phase 2: Axicabtagene Ciloleucel + Utomilumab | Intervention Type: BIOLOGICAL; Name: Utomilumab; Assigned to Arm(s): Phase 1: Cohort 1: Axicabtagene Ciloleucel + Utomilumab 10 mg, Phase 1: Cohort 2: Axicabtagene Ciloleucel + Utomilumab 30 mg, Phase 1: Cohort 3: Axicabtagene Ciloleucel + Utomilumab 100 mg, Phase 1: Cohort 4: Axicabtagene Ciloleucel + Utomilumab 200 mg, Phase 1: Cohort 5: Axicabtagene Ciloleucel + Utomilumab 400 mg, Phase 2: Axicabtagene Ciloleucel + Utomilumab

Answer: D