Actively Recruiting
CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)
Led by Baylor College of Medicine · Updated on 2025-07-25
60
Participants Needed
2
Research Sites
1186 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
The subject has a type of lymph gland cancer called Lymphoma. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs. Both antibodies and T cells have been used to treat patients with cancers; they both have shown promise, but have not been strong enough to cure most patients. Investigators hope that both will work better together. Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. They now want to test whether these genetically modified T cells given after chemotherapy will be more effective at killing cancer cells. The gene that will be put into the T cells makes an antibody called anti-CD30. This antibody sticks to lymphoma cells because of a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong enough to cure most patients. For this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30 chimeric receptor-activated T cells (CD30.CAR T cells) seem to kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are unknown. Several studies suggest that the infused T cells need room to be able to multiply and grow to accomplish their functions, and that this may not happen if there are too many other T cells in circulation. Because of that, doctors may use chemotherapy drugs to decrease the level of circulating T cells prior to the CD30.CAR T cells infusion. This is called "lymphodepletion" CD30.CAR T cells have previously been studied in lymphoma patients.
CONDITIONS
Official Title
CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory Hodgkin's lymphoma (HL) or Non-Hodgkin lymphoma (NHL)
- Tumor positive for CD30 as tested in a certified pathology laboratory
- Hemoglobin level of 7.0 or higher (may be transfused value)
- Signed informed consent by patient or guardian
- Karnofsky or Lansky performance score greater than 60%
- Age 16 to 75 for initial patients at each dose level; then age 12 to 75 if no dose-limiting toxicities
- Bilirubin level 1.5 times or less than upper normal limit
- AST level 3 times or less than upper normal limit
- Estimated glomerular filtration rate (GFR) over 70 mL/min
- Pulse oxygen level over 90% on room air
- No significant arrhythmias on EKG
- Available autologous T cells expressing at least 15% CD30CAR
- Fully recovered from prior chemotherapy side effects
- Adequate lung function with FEV1, FVC, and DLCO at least 50% of expected
- Sexually active patients agree to use effective birth control during and 6 months post-study
- Signed informed consent understood and given
You will not qualify if you...
- Active infection with HIV or HTLV (may be pending)
- Active bacterial, fungal, or viral infections
- Use of investigational agents or tumor vaccines within past 6 weeks
- Anti-CD30 antibody therapy within past 4 weeks
- Rapidly progressing disease failing prior chemotherapy
- Bulky disease with mass 10 cm or larger or mediastinal mass exceeding 33% chest diameter
- History of allergic reactions to murine protein products
- Pregnant or lactating
- Tumor causing or risking airway blockage
- Current use of systemic corticosteroids at 0.5 mg/kg/day prednisone dose or higher
- Active hemorrhagic cystitis
- Symptomatic heart disease classified as 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 A Ramos, MD
CONTACT
V
Vicky Torrano, RN
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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