Status:
RECRUITING
Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Conditions:
Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
Classical Hodgkin Lymphoma
Eligibility:
All Genders
12-75 years
Phase:
PHASE1
Brief Summary
This study involved patients that have a cancer called diffuse large B cell lymphoma (DLBCL), NK and T cell lymphomas (NK/TL) or classical Hodgkin lymphoma (cHL) (hereafter these 3 diseases will be re...
Detailed Description
Earlier, healthy donors gave blood for us to make CD30.CAR-EBVST cells in the laboratory. These cells were grown and frozen and the investigators will select the donor which the investigators think is...
Eligibility Criteria
Inclusion
- Diagnosis and clinical course falling into one of the following categories:
- Hodgkin lymphoma
- Aggressive non-Hodgkin lymphoma
- ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma
- ALK-positive anaplastic T cell lymphoma
- CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.
- Age 12 to 75.
- Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal.
- AST 3 times or less than the upper limit of normal.
- Estimated GFR \> 70 mL/min.
- Pulse oximetry of \> 90% on room air
- EKG shows no significant arrhythmias
- Karnofsky or Lansky score of \> 60%.
- Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry.
- Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
- 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.
- Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.
Exclusion
- Received an investigational cell therapy or vaccine within the past 6 weeks.
- Received an investigational small molecule drug within the past 2 weeks.
- Received CD30 antibody-based therapy within the previous 4 weeks.
- Received gemcitabine-containing chemotherapy within the previous 12 weeks
- History of hypersensitivity reactions to murine protein-containing products.
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion).
- Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone.
- Active significant, uncontrolled bacterial, viral or fungal infection.
- Symptomatic cardiac disease (NYHA Class III or IV disease).
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2037
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04288726
Start Date
September 16 2020
End Date
June 1 2037
Last Update
July 20 2025
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030