Status:
RECRUITING
Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
CD30-Positive Diffuse Large B-Cell Lymphoma
Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type
Eligibility:
All Genders
12-75 years
Phase:
PHASE1
Brief Summary
This study involves patients that have a cancer called diffuse large B cell lymphoma (DLBCL), Natural killer/T-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as ly...
Detailed Description
This is a dose escalation study. This means that at the beginning, patients will be started on the lowest dose (1 of 4 different levels) of C7R.CD30.CAR-EBVST cells. Once the lower dose schedule prove...
Eligibility Criteria
Inclusion
- Diagnosis and clinical course falling into one of the following categories:
- Hodgkin lymphoma
- CD30+ aggressive B-cell 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 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).
- AST less than 3 times the upper limit of normal.
- Estimated GFR \> 70 mL/min.
- Pulse oximetry of \> 90% on room air
- Karnofsky or Lansky score of \> 60%.
- 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.
- 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 or 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 :
October 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 27 2043
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06176690
Start Date
October 27 2025
End Date
June 27 2043
Last Update
November 13 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