Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-75
SponsorBaylor College of Medicine

About this trial

This study involves patients with diffuse large B cell lymphoma (DLBCL), natural killer/T-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma) whose disease has returned or not responded to treatment.

Previous research combined antibodies and T cells to treat cancer. Antibodies bind to foreign substances, and T cells are infection-fighting white blood cells that can kill tumor cells. Both approaches have shown promise but have not been sufficient to cure most patients. In prior studies, an antibody targeting CD30, a protein found on some T cells and cancer cells, was joined to T cells through gene transfer to create CD30.CAR T cells.

Another study showed encouraging responses using CD30.CAR T cells made from a patient's own blood and returned to the same patient (autologous cells). In an ongoing study, patients have been treated with CD30.CAR T cells derived from healthy donors (allogeneic cells), allowing use of banked cells without individualized manufacturing. This approach has shown promising clinical activity with no safety concerns to date.

In this study, investigators are evaluating CD30.CAR-EBVST cells modified with an additional molecule called C7R, which has been shown in laboratory studies to enhance anti-cancer effects. The study aims to assess the safety and effectiveness of these allogeneic, banked C7R-modified CD30.CAR-EBVST cells and determine whether they may help treat lymphoma.

As an added safety measure, the modified T cells include a marker called iC9. If significant side effects occur, patients may receive rimiducid, which can eliminate the infused T cells. Rimiducid is not yet FDA approved but has been tested in patients without significant side effects.

Eligibility criteria

Qualifiers

Hodgkin lymphoma

CD30+ aggressive B-cell lymphoma

ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma

ALK-positive anaplastic T cell lymphoma

Disqualifiers

Received an investigational cell therapy or vaccine within the past 6 weeks.

Received an investigational small molecule drug within the past 2 weeks.

Received anti-CD30 antibody-based therapy within the previous 4 weeks.

History of hypersensitivity reactions to murine protein-containing products.

Trial design

Treatments tested in this trial

  • C7R.CD30.CAR-EBVST cells

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators

Baylor College of Medicine

Lead sponsor

The Methodist Hospital Research Institute

Collaborator

Center for Cell and Gene Therapy, Baylor College of Medicine

Collaborator