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

Launched by BAYLOR COLLEGE OF MEDICINE · Dec 11, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new type of treatment for patients with certain types of lymphoma, including Hodgkin lymphoma and aggressive B-cell lymphoma. The goal of the study is to see if a modified version of a special cell therapy, known as CD30.CAR T cells, can help fight these cancers more effectively. The modified cells are created from healthy donors and have an added component that may help them work better and last longer in the body. Patients in this trial will also have a safety measure in place that allows the treatment to be stopped quickly if side effects become serious.

To participate in the trial, patients need to be between 12 and 75 years old, have a specific type of CD30-positive lymphoma, and meet certain health criteria, like having normal liver function and being recovered from previous chemotherapy. Those who join the study can expect regular check-ups and monitoring to assess the treatment's effects and any side effects they might experience. It's important to note that while this treatment is not yet approved by the FDA, it has shown promise in early studies, and participants will have the opportunity to contribute to important research in cancer care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Diagnosis and clinical course falling into one of the following categories:
• • 1. Hodgkin lymphoma
• • 2. CD30+ aggressive B-cell lymphoma
• • 3. ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma
• • 4. ALK-positive anaplastic T cell lymphoma
• • 2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.
• • 3. Age 12 to 75.
• • 4. Bilirubin less than or equal to 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin less than or equal to 3 times the upper limit of normal).
• • 5. AST less than 3 times the upper limit of normal.
• • 6. Estimated GFR \> 70 mL/min.
• • 7. Pulse oximetry of \> 90% on room air
• • 8. Karnofsky or Lansky score of \> 60%.
• • 9. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
• • 10. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
• • 11. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.
• Exclusion Criteria:
• • 1. Received an investigational cell therapy or vaccine within the past 6 weeks.
• • 2. Received an investigational small molecule drug within the past 2 weeks.
• • 3. Received CD30 antibody-based therapy within the previous 4 weeks.
• • 4. History of hypersensitivity reactions to murine protein-containing products.
• • 5. Pregnant or lactating.
• • 6. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).
• • 7. Current use of systemic corticosteroids at a dose equivalent to or higher than 10 mg/day of prednisone.
• • 8. Active significant, uncontrolled bacterial, viral or fungal infection.
• • 9. Symptomatic cardiac disease (NYHA Class III or IV disease).