T Cells Expressing Fully-human Anti-CD19 and Anti-CD20 Chimeric Antigen Receptors for Treating B-cell Malignancies and Hodgkin Lymphoma

• Status: Completed
• Trial end date: 2021-06-11

Summary

Background:

CD19 and CD20 are often found on certain cancer cells. Researchers think that a person s T cells can be modified in a lab to kill cells that have CD19 and CD20 on the surface.

Objective:

To see if it is safe to give anti-CD19 and anti-CD20 CAR T cells to people with a B cell cancer or Hodgkin lymphoma.

Eligibility:

People ages 18 and older with a B cell cancer or Hodgkin lymphoma that has not been controlled with standard therapies

Design:

Participants will be screened under protocol 01C0129 with:

Medical history

Physical exam

Blood and heart tests

Bone marrow biopsy: A needle is inserted into the participant s hip bone to remove a small amount of marrow.

Scans

Participants will have apheresis: Blood will be removed through a vein. The blood with circulate through a machine that removes the T cells. The rest of the blood will be returned to the participant.

Once a day for 3 days before they get the T cells, participants will receive chemotherapy through a vein.

Participants will receive the T cells through a vein. They will stay in the hospital for at least 9 days.

Participants may have a lumbar puncture: A needle will remove fluid from the spinal cord.

Participants may have a tumor biopsy.

Participants will repeat the screening tests throughout the study.

Participants will have follow-up visits 2 weeks after infusion; monthly for 4 months; at 6, 9, and 12 months; every 6 months for 3 years; and then annually for 5 years. Participants will then be contacted annually for 15 years.

• Phase: Phase 1

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Fludarabine; Rituximab