Anti-CD30 CAR-T Cell Therapy in Relapsed and Refractory Hodgkin Lymphoma.
Carlos A Ramos, Natalie S Grover, Anne W Beaven...
https://pubmed.ncbi.nlm.nih.gov/32701411Actively Recruiting
Phase 1
Age: 12Years - 75Years
All Genders
ID02917083
Phase I Study of Relapsed CD30 Expressing Lymphoma Treated With CD30 CAR T Cells (RELY-30)
Led by Baylor College of Medicine · Updated on 2025-07-25
60
Participants Needed
2
Research Sites
722 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 studying a type of lymph gland cancer called lymphoma, specifically relapsed or refractory Hodgkin's and Non-Hodgkin lymphoma that express the CD30 protein. This research explores a new approach by combining antibodies and T cells, which are infection-fighting blood cells, to better target and kill cancer cells. The study focuses on genetically modifying T cells to recognize and attack lymphoma cells using a gene that produces an anti-CD30 antibody on the T cells, called CD30 chimeric antigen receptor (CAR) T cells. The study involves collecting T cells from participants either by blood draws or apheresis, then modifying these cells with the anti-CD30 gene in the lab. These CAR T cells are frozen and later infused back into the patient in one injection on Day 0. Participants may receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine or clofarabine beforehand to help the modified T cells multiply. The study tests three escalating dose levels of CAR T cells to find a safe dose. If the lymphoma remains stable or shrinks after 8 weeks, up to six additional doses may be given at 8 to 12 week intervals. Participants will be closely monitored during and after the infusion, including blood tests taken before and after treatment to study how the CAR T cells persist and work. Follow-up includes frequent blood draws over 15 years to track long-term effects. The main outcomes measured are dose-limiting toxicities within 6 weeks and lymphoma response at 8 weeks. Monitoring also includes physical exams, imaging, and lab tests to ensure safety and evaluate treatment impact.
CONDITIONS
Brief Title
CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)
Who Can Participate
Age: 12Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory Hodgkin's Lymphoma or Non-Hodgkin Lymphoma
- Tumor must be CD30 positive as confirmed by a certified pathology laboratory
- Hemoglobin level of 7.0 or higher (including transfused value)
- Karnofsky or Lansky performance score greater than 60%
- Age between 12 and 75 years (initially 16 to 75 for first patients per dose level)
- Bilirubin level 1.5 times or less than the upper limit of normal
- AST level 3 times or less than the upper limit of normal
- Estimated glomerular filtration rate (GFR) greater than 70 mL/min
- Pulse oxygen level greater than 90% on room air
- Electrocardiogram showing no significant arrhythmias
- Availability of autologous T cells with at least 15% expression of CD30 CAR
- Recovery from all acute non-hematologic toxic effects of prior chemotherapy
- Adequate lung function with FEV1, FVC and DLCO at or above 50% of expected values
- Use of effective birth control during the study and for 6 months after if sexually active
- Signed informed consent by patient or guardian
You will not qualify if you...
- Active infection with HIV or HTLV (may be pending at time of screening)
- Active bacterial, viral, or fungal infection
- Receiving investigational agents or tumor vaccines within previous 6 weeks
- Anti-CD30 antibody therapy within previous 4 weeks
- Rapidly progressive disease defined as failure to respond to prior chemotherapy
- Bulky disease with mass 10 cm or larger or mediastinal disease exceeding 33% of chest diameter
- History of allergic reactions to murine protein-containing products
- Pregnancy or lactation
- Tumor location that could cause airway obstruction if enlarged
- Current use of systemic corticosteroids at dose equivalent to 0.5 mg/kg/day prednisone or higher
- Active hemorrhagic cystitis
- Symptomatic cardiac disease classified as NYHA Class III or IV
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Variable, includes initial infusion on Day 0 and up to six additional doses at 8 to 12 week intervals
Participants undergo blood collection or pheresis to prepare CD30 CAR T cells, receive lymphodepleting chemotherapy if applicable, followed by an injection of CD30 CAR T cells. Additional injections may be given every 8 to 12 weeks depending on disease stability.
1 infusion visit on Day 0 with at least 3 hours monitoring, plus up to 6 additional infusion visits with monitoring every 8 to 12 weeks
Follow-up
Duration - Up to 15 years
Participants have blood drawn at multiple timepoints to monitor the CD30 CAR T cells and their effects, with visits continuing for up to 15 years to assess long-term outcomes.
Visits at 1, 2, 3 (optional), 4, 6, and 8 weeks; then every 3 months for 1 year; every 6 months for 4 years; then yearly visits
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
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Research Team
C
Carlos A Ramos, 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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