Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: T Cells Expressing a Fully-Human Anti-CD19 Chimeric Antigen Receptor for Treating B-cell Malignancies
Brief Summary: Background:

The immune system fights infection and can affect cancer cells. T cells are white blood cells that are a major part of the immune system. T cells can destroy tumors. Researchers want to try to manipulate the immune system to better recognize and kill tumor cells.

Objective:

To test the safety of giving T cells expressing a novel fully-human anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) to people with advanced B-cell cancer.

Eligibility:

People ages 18-73 with a B-cell cancer that has not been controlled by other therapies.

Design:

Participants will be screened with:

Physical exam

Blood and urine tests

Heart tests

Bone marrow sample taken

Scans in machines that take pictures

Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. The rest of the blood is returned through a needle in the other arm.

The cells will be changed in a laboratory.

Participants will get 2 chemotherapy drugs over 3 days.

Two days later, participants will check into the hospital. They will get an intravenous (IV) catheter in an arm or chest vein. They will get the T cells through the IV in 1 infusion.

After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.

Participants will have visits 6 visits for 1 year after the infusion. Some may have more follow-up visits.

Participants may samples taken of spinal fluid, bone marrow, and tumors.

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Options:
A: Arm Label: Tisagenlecleucel; Type: EXPERIMENTAL; Interventions: Biological: Tisagenlecleucel | Intervention Type: BIOLOGICAL; Name: Tisagenlecleucel; Assigned to Arm(s): Tisagenlecleucel
B: 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
C: Intervention Type: BIOLOGICAL; Name: chimeric antigen receptor T cells; Assigned to Arm(s): N/A
D: Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Biological: lisocabtagene maraleucel | Intervention Type: BIOLOGICAL; Name: lisocabtagene maraleucel; Assigned to Arm(s): Treatment

Answer: B