Actively Recruiting
Constitutive IL7R (C7R) Modified Banked Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes for Relapsed or Refractory CD30-Positive Lymphomas
Led by Baylor College of Medicine · Updated on 2026-04-13
90
Participants Needed
2
Research Sites
778 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
Researchers are evaluating the safety and effectiveness of a new type of cell therapy for patients with certain types of lymphoma, including diffuse large B cell lymphoma, natural killer/T-cell lymphoma, and classical Hodgkin lymphoma, whose disease has returned or not responded to previous treatments. This Phase 1 study focuses on allogeneic CD30.CAR-EBVST cells modified with a molecule called C7R, designed to enhance anti-cancer effects. The therapy includes a safety marker called iC9, which allows removal of the infused cells if severe side effects occur. Participants receive treatment in sequential groups at one of four dose levels of the C7R.CD30.CAR-EBVST cells. Before infusion, patients may undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine to help the infused cells expand. The cell therapy is given as a single intravenous infusion, with premedication possible to reduce infusion reactions. The dose escalates only if the previous level is safe, and dosing may be adjusted based on observed toxicities. Throughout the study, participants undergo screening including lab tests, imaging, and human leukocyte antigen testing to find a compatible cell product. After infusion, patients stay near the treatment center for monitoring and have regular follow-up visits to assess safety and disease status through exams, labs, imaging, and biopsies if needed. Blood samples are collected to track the infused cells, and participants are followed for up to 15 years to observe long-term effects and treatment outcomes such as tumor response and disease progression.
CONDITIONS
Brief Title
Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Hodgkin lymphoma, CD30-positive aggressive B-cell lymphoma, ALK-negative or ALK-positive anaplastic T cell lymphoma, or other peripheral T-cell lymphoma
- Tumor confirmed to be CD30-positive by a certified pathology laboratory
- Age between 12 and 75 years
- Bilirubin less than or equal to 2 times the upper limit of normal (or up to 3 times for Gilbert syndrome)
- AST less than 3 times the upper limit of normal
- Estimated glomerular filtration rate greater than 70 mL/min
- Pulse oximetry greater than 90% on room air
- Karnofsky or Lansky performance score greater than 60%
- Recovered from all acute non-hematologic side effects of prior chemotherapy
- Sexually active patients willing to use effective birth control during the study and for 6 months after; male partners should use a condom
- Informed consent provided and understood 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 anti-CD30 antibody therapy within the previous 4 weeks
- History of allergic reactions to mouse protein-containing products
- Pregnant or breastfeeding
- Tumor location that could cause airway obstruction
- Current use of systemic corticosteroids at doses equivalent to or higher than 10 mg/day prednisone
- Active significant uncontrolled bacterial, viral, or fungal infection
- Symptomatic cardiac disease classified as NYHA Class III or IV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants undergo laboratory testing, imaging studies, confirmation of CD30 expression, and HLA testing to identify the appropriate cell line.
Duration - Single infusion on Day 0 with monitoring for 28 days for dose limiting toxicity
Participants receive a single intravenous infusion of C7R.CD30.CAR-EBVST cells at one of four dose levels based on safety data. Premedication may be given to reduce infusion-related reactions. Lymphodepleting chemotherapy may be administered prior to infusion as clinically appropriate.
Participants are monitored in the clinical setting following infusion and must remain near the treatment center for a defined period. Visit frequency varies with initial close monitoring post-infusion.
Duration - Up to 15 years after the most recent infusion
Participants undergo scheduled follow-up evaluations including physical examinations, laboratory testing, imaging studies, and blood sample collection to assess safety, disease status, and persistence of infused cells. Tumor assessments may include imaging and biopsy when clinically indicated.
Frequent visits early after infusion with less frequent long-term follow-up visits over several years.
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
Not Yet Recruiting
Research Team
P
Premal Lulla, MD
V
Vicky Torrano, RN
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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