RecruitingPhase 1NCT06176690

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

Constitutive IL7R (C7R) Modified Banked Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas


Sponsor

Baylor College of Medicine

Enrollment

90 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 12 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an off-the-shelf (pre-made, from a donor) CAR T cell therapy — immune cells engineered to target and kill CD30-positive lymphomas — in patients with Hodgkin lymphoma, aggressive B-cell lymphomas, or T-cell lymphomas that express the CD30 protein. **You may be eligible if...** - You are between 12 and 75 years old - You have Hodgkin lymphoma, CD30-positive aggressive B-cell lymphoma, or anaplastic T-cell lymphoma (ALK-positive or negative) or other peripheral T-cell lymphoma - Your cancer tests positive for the CD30 protein - You have adequate liver, kidney, and lung function and a performance score above 60% **You may NOT be eligible if...** - Your cancer does not express the CD30 protein - You have active, uncontrolled infections - You are pregnant or breastfeeding - Your organ function is too impaired to safely receive the treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALC7R.CD30.CAR-EBVST cells

The dose is based on the number of CD30.CAR- expressing cells. In our previous study the highest dose was 4 × 10\^8 cells/m2 and we did not reach an MTD. On Day 0, patients will receive their planned dose of investigational T cell product by IV infusion over approximately 1 to 10 minutes in an expected volume of 1 to 50 mL.


Locations(2)

Houston Methodist Hospital

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

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NCT06176690


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