Using donor T cells to treat relapsed or refractory CD30-positive lymphomas

A Phase 1 Study Evaluating the Safety and Activity of Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas

This study is testing whether specially engineered T cells from healthy donors can help people with relapsed or hard-to-treat CD30-positive lymphomas, like Hodgkin lymphoma, feel better and improve their chances of recovery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 12 Years to 75 Years
• Sex: All
• Sponsor: Baylor College of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, cyclophosphamide, fludarabine
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT04288726 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of allogeneic CD30.CAR-EBV specific T cells in patients with relapsed or refractory CD30-positive lymphomas, including Hodgkin lymphoma and aggressive non-Hodgkin lymphoma. Patients will receive a dose escalation of these specially engineered T cells, which are derived from healthy donors and trained to target cancer cells expressing the CD30 antigen. The study will monitor the patients for safety and effectiveness as the dosage increases, with the goal of identifying the optimal dose that balances benefits and risks.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 12 to 75 with relapsed or refractory CD30-positive lymphomas who have recovered from prior chemotherapy.

Not a fit: Patients who have received investigational cell therapies or vaccines within the past 6 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat CD30-positive lymphomas.

How similar studies have performed: While the approach of using engineered T cells is gaining traction, this specific application of CD30.CAR-EBVST cells in this patient population is relatively novel and has not been extensively tested in prior studies.

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).

Where this trial is running

Houston, Texas and 1 other locations

• Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
• Texas Children's Hospital — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Carlos Ramos, MD — Baylor College of Medicine
• Study coordinator: Carlos Ramos, MD

Conditions Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type; Classical Hodgkin Lymphoma; CD30-Positive Lymphoma; Hodgkin lymphoma; non-Hodgkin lymphoma; CD30 CAR