CAR-T Cell Therapy for Lymphoma
(CABAL2 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you have used certain investigational drugs or therapies recently, or if you are currently using high-dose corticosteroids.
What data supports the effectiveness of the treatment C7R.CD30.CAR-EBVST cells for lymphoma?
Research shows that modifying T-cells with a C7R receptor can enhance their ability to fight tumors, as seen in Epstein-Barr virus-specific T-cells that controlled lymphoma more effectively in a mouse model. Additionally, CAR T-cell therapy, which is part of this treatment, has been effective in treating various types of lymphoma, including Hodgkin lymphoma.12345
Is CAR-T cell therapy generally safe for humans?
How is the C7R.CD30.CAR-EBVST cell treatment different from other lymphoma treatments?
This treatment is unique because it combines a chimeric antigen receptor (CAR) targeting CD30 with Epstein-Barr virus-specific T-cells (EBVSTs) enhanced by a constitutively active IL7 receptor (C7R), which improves the persistence and expansion of the T-cells, potentially leading to better control of lymphoma.123511
What is the purpose of this trial?
This study involves patients that have a cancer called diffuse large B cell lymphoma (DLBCL), Natural killer/T-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma). Patients' lymphoma has come back or not gone away after treatment.A previous research study at Baylor combined two ways of fighting disease: antibodies and T cells. Antibodies are proteins that bind to bacteria, viruses and other foreign substances to prevent disease. T-cells are special infection-fighting white blood cells that can kill tumor cells or cells infected with bacteria and viruses. Both have shown promise treating cancer, but neither has been strong enough to cure most patients. In the previous study, an antibody called anti-CD30 which is found on the surface of some T-cells and cancer cells, and had been used to treat lymphoma with limited success, was joined to the T-cells through a process called gene transfer, resulting in CD30.CAR T cells.Another study saw encouraging responses using CD30.CAR T cells made in a lab from a patients' own blood then injected back into the same patient to treat their lymphoma. These cells are termed 'autologous' because they're given back to the original patient.In an ongoing study, patients were treated with allogeneic CD30.CAR T cells, which are made from healthy donors instead of the patients. The use of allogenic cells avoids a lengthy manufacture time since the products are stored as a bank and available on demand. This ongoing trial has preliminarily shown promising clinical activity with no safety concerns.With the current study, investigators plan to extend the anti-cancer effects of the CD30.CAR T cell by attaching another molecule called C7R, which has made CAR T cells have deeper and longer anticancer effects in the laboratory. The aim is to study the safety and effectiveness of allogeneic banked CD30.CAR-EBVST cells that also carry the C7R molecule, to learn the side effects of C7R modified CD30.CAR-EBVST cells in lymphoma patients, and to see whether this therapy may help them. As an extra safety step, the C7R containing T cells will also have a marker called iC9. If a patient experiences intolerable side effects from the C7R T cells, they could receive a medication called 'rimiducid' that can eliminate the C7R containing T cells by binding iC9, thereby potentially resolving the side effects. While not yet FDA approved, rimiducid has been tested in patients before without bad side effects.
Research Team
Premal Lulla, MD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
This trial is for patients with certain types of lymphoma, including diffuse large B cell, natural killer/T-cell, or classical Hodgkin lymphoma that has persisted or returned after treatment. Participants must meet specific health criteria not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion Chemotherapy
Participants receive cyclophosphamide and fludarabine to reduce T cell count before infusion
Treatment
Participants receive C7R.CD30.CAR-EBVST cell infusion at one of four dose levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- C7R.CD30.CAR-EBVST cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
The Methodist Hospital Research Institute
Collaborator
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborator