Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase 1/1b Study of Redirected Autologous T Cells Engineered to Contain an Anti CD19 and Anti CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains in Patients With Relapsed and/or Refractory CD19 or CD20 Positive B Cell Malignancies
Brief Summary: This is a phase 1/1b, interventional single arm, open label, treatment study designed to evaluate the safety and feasibility of infusion of autologous T cells engineered to contain an anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) single chain variable fragment (scFv) coupled to cluster of differentiation CD3ζ (CD3ζ) and co-stimulatory domain 4-1BB (4-1BB) signaling domains in patients with relapsed and/or refractory CD19 or CD20 positive B cell malignancies


Options:
A: Arm Label: Diffuse Large B Cell Lymphoma(DLBCL); Type: EXPERIMENTAL; Interventions: Biological: Anti-CD19 CAR-T cells and Anti-CD20 CAR-T cells | Intervention Type: BIOLOGICAL; Name: Anti-CD19 CAR-T cells and Anti-CD20 CAR-T cells; Assigned to Arm(s): Diffuse Large B Cell Lymphoma(DLBCL)
B: Arm Label: CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg); Type: EXPERIMENTAL; Interventions: Biological: CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg) | Arm Label: CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg); Type: EXPERIMENTAL; Interventions: Biological: CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg) | Arm Label: CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg); Type: EXPERIMENTAL; Interventions: Biological: CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg) | Arm Label: CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg); Type: EXPERIMENTAL; Interventions: Biological: CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg) | Intervention Type: BIOLOGICAL; Name: CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg); Assigned to Arm(s): CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg) | Intervention Type: BIOLOGICAL; Name: CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg); Assigned to Arm(s): CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg) | Intervention Type: BIOLOGICAL; Name: CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg); Assigned to Arm(s): CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg) | Intervention Type: BIOLOGICAL; Name: CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg); Assigned to Arm(s): CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)
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: Single Arm; Type: EXPERIMENTAL; Interventions: Biological: CD19 CAR T cells | Intervention Type: BIOLOGICAL; Name: CD19 CAR T cells; Assigned to Arm(s): Single Arm

Answer: B