Allogeneic CD30.CAR-EBVSTs in Patients with Relapsed or Refractory CD30-Positive Lymphomas

Launched by BAYLOR COLLEGE OF MEDICINE · Feb 26, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with certain types of lymphoma, including Hodgkin lymphoma and aggressive non-Hodgkin lymphoma. The researchers are testing a special type of immune cell, called allogeneic CD30.CAR-EBVST cells, which are taken from healthy donors. These cells are designed to target and attack lymphoma cells that have a specific marker called CD30, and they may also be effective against lymphoma cells that contain the Epstein-Barr virus (EBV). The main goal of the study is to determine the highest safe dose of these cells after chemotherapy and to learn more about their side effects and effectiveness in treating lymphoma.

To join the study, participants need to be between the ages of 12 and 75 and have a diagnosis of CD30-positive lymphoma. They should also be recovering from previous treatments and meet certain health criteria, such as stable liver and kidney function. Throughout the trial, participants will receive the new treatment, and the research team will closely monitor their health and response to the therapy. It's important to note that this trial is currently recruiting patients, and anyone interested should discuss their eligibility with their healthcare provider.

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ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Diagnosis and clinical course falling into one of the following categories:
• • 1. Hodgkin lymphoma
• • 2. Aggressive non-Hodgkin 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 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal.
• • 5. AST 3 times or less than the upper limit of normal.
• • 6. Estimated GFR \> 70 mL/min.
• • 7. Pulse oximetry of \> 90% on room air
• • 8. EKG shows no significant arrhythmias
• • 9. Karnofsky or Lansky score of \> 60%.
• • 10. Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry.
• • 11. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
• • 12. 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.
• • 13. 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. Received gemcitabine-containing chemotherapy within the previous 12 weeks
• • 5. History of hypersensitivity reactions to murine protein-containing products.
• • 6. Pregnant or lactating.
• • 7. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).
• • 8. Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone.
• • 9. Active significant, uncontrolled bacterial, viral or fungal infection.
• • 10. Symptomatic cardiac disease (NYHA Class III or IV disease).