Actively Recruiting
Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas
Led by Baylor College of Medicine · Updated on 2025-07-20
18
Participants Needed
2
Research Sites
871 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
T
The Methodist Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 referred to as lymphoma). Patients lymphoma has come back or not gone away after treatment. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, the patients are being asked to volunteer in this research study. In this study the investigators want to test a type of T cell made from a normal donor. The T cells the investigators will use are called Epstein Barr virus (EBV) specific T cells (EBVSTs) and are cells that the investigators have trained in the laboratory to recognize a EBV which is the virus that causes mono or kissing disease. Some patients with lymphoma have EBV in their cancer cells. Researchers have given T cell lines from normal donor EBVSTs to lymphoma patients who have EBV in their lymphoma cells and have seen responses in about half the patients. The cells have have been generated and are frozen in a bank. The cells are called "allogeneic" (meaning the donor is not related to the patient). CD30.CAR in EBV-specific T cells (called allogeneic CD30.CAR-EBVST) from the blood of healthy donors. The investigators are giving the cells to patients with lymphoma cells that express CD30. If the lymphoma cells also express EBV there may be some benefit from targeting both proteins. The purpose of this study is to find out the highest safe dose of allogeneic CD30.CAR-EBVST cells given following chemotherapy and used to treat lymphoma. The investigators will learn the side effects of CD30.CAR-EBVST cells in patients and see whether this therapy may help lymphoma patients
CONDITIONS
Official Title
Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Hodgkin lymphoma, aggressive non-Hodgkin lymphoma, ALK-negative or ALK-positive anaplastic T cell lymphoma, or other peripheral T-cell lymphoma
- Tumor that tests positive for CD30 in a certified pathology lab
- Age between 12 and 75 years
- Bilirubin level 2 times or less the upper limit of normal (3 times if Gilbert syndrome)
- AST level 3 times or less the upper limit of normal
- Estimated glomerular filtration rate (GFR) greater than 70 mL/min
- Pulse oxygen level above 90% on room air
- Electrocardiogram (EKG) showing no significant arrhythmias
- Karnofsky or Lansky performance score above 60%
- Availability of donor T cells with at least 15% CD30CAR expression
- Recovery from all acute non-blood-related side effects of prior chemotherapy
- Willingness to use effective birth control during the study and for 6 months after, with male partners using condoms
- Informed consent signed by patient or guardian
You will not qualify if you...
- Received investigational cell therapy or vaccine within the past 6 weeks
- Received investigational small molecule drug within the past 2 weeks
- Received CD30 antibody therapy within the previous 4 weeks
- Received gemcitabine chemotherapy within the previous 12 weeks
- History of allergic reactions to mouse protein-containing products
- Pregnant or lactating
- Tumor located where growth could block airway
- Current use of high-dose systemic corticosteroids (more than 10 mg/day prednisone equivalent)
- Active serious infections that are not controlled
- Symptomatic severe heart disease (NYHA Class III or IV)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
2
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Carlos Ramos, MD
CONTACT
V
Vicky Torrano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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