Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Assessment of the Safety and Feasibility of Administering T-Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With B-Cell Lymphoma
Brief Summary: Background:

The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with B cell lymphomas or leukemias that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-cluster of differentiation 19 (CD19) incorporated in the retrovirus.

Objective:

The purpose of this study is to determine a safe number of these cells to infuse and to see if these particular tumor-fighting cells (anti-CD19 cells) cause tumors to shrink.

Eligibility:

- Adults age 18-70 with B cell lymphomas or leukemias expressing the CD19 molecule.

Design:

Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed

Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-CD19 cells. Leukapheresis is a common procedure, which removes only the white blood cells from the patient.

Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy and the anti-CD19 cells. They will stay in the hospital for about 4 weeks for the treatment.

Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.


Options:
A: Arm Label: Treatment Regimen; Type: EXPERIMENTAL; Interventions: Drug: Fludarabine, Drug: Cyclophosphamide, Biological: anti-CD19 CAR-T cells | Intervention Type: DRUG; Name: Fludarabine; Assigned to Arm(s): Treatment Regimen | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Treatment Regimen | Intervention Type: BIOLOGICAL; Name: anti-CD19 CAR-T cells; Assigned to Arm(s): Treatment Regimen
B: Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Biological: lisocabtagene maraleucel | Intervention Type: BIOLOGICAL; Name: lisocabtagene maraleucel; Assigned to Arm(s): Treatment
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: FBTA05 | Intervention Type: DRUG; Name: FBTA05; Assigned to Arm(s): 1
D: 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)

Answer: D