Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM).
Brief Summary: The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B).

All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT).

Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event.

Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion.


Options:
A: Arm Label: Arm A - Standard of Care (SOC); Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard of Care | Arm Label: Arm B - JCAR017; Type: EXPERIMENTAL; Interventions: Genetic: JCAR017 | Intervention Type: DRUG; Name: Standard of Care; Assigned to Arm(s): Arm A - Standard of Care (SOC) | Intervention Type: GENETIC; Name: JCAR017; Assigned to Arm(s): Arm B - JCAR017
B: 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
C: Intervention Type: PROCEDURE; Name: Procedure - Adoptive cell transfer; Assigned to Arm(s): N/A
D: Arm Label: CD30 positive NHL subtypes; Type: EXPERIMENTAL; Interventions: Drug: CD30.CAR-T | Intervention Type: DRUG; Name: CD30.CAR-T; Assigned to Arm(s): CD30 positive NHL subtypes

Answer: A