Actively Recruiting
Led by National Cancer Institute (NCI) · Updated on 2026-04-06
124
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating a gene therapy treatment for adults aged 18 to 72 with cancers that express the CD70 protein, such as renal cell carcinoma, pancreatic cancer, breast cancer, melanoma, and ovarian cancer. This study aims to determine if modifying a person's white blood cells with an anti-CD70 receptor can safely shrink tumors and assess the safety of this approach. The therapy involves using a virus to change the genes of selected white blood cells to target cancer cells. Participants receive a preparative chemotherapy regimen with cyclophosphamide and fludarabine to prepare their body for the gene-modified cells. On the day of treatment, they receive an infusion of their own peripheral blood lymphocytes modified with the anti-CD70 receptor, followed by high-dose aldesleukin to support immune activity. The treatment is delivered intravenously over several days in a hospital setting. Some participants may receive escalating doses during the Phase I portion, while others receive a maximum tolerated dose in Phase II. The study includes two cohorts based on cancer type. Before treatment, participants undergo screening including medical history, physical exams, scans, and blood tests. Leukapheresis is performed to collect white blood cells for modification. After infusion, participants are monitored closely in the hospital and take antibiotics for six months. Follow-up visits occur every 1 to 3 months in the first year and every 6 months in the second year, involving lab tests, imaging, and physical exams to assess tumor response and safety. Researchers measure treatment-related side effects and tumor shrinkage over time.
CONDITIONS
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 7 days before cell infusion
Participants receive a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine before cell infusion.
Visits over 7 days including Days -7 to -3 or -5 depending on phase
Duration - Day 0 plus up to 3 days of aldesleukin dosing
Participants receive an infusion of peripheral blood lymphocytes transduced with anti-hCD70 CAR followed by high-dose aldesleukin treatment.
1 day for cell infusion and up to 3 days of dosing visits (maximum 9 doses)
Duration - Approximately 6 weeks (plus or minus 2 weeks) after treatment
Participants undergo evaluation of lesions and monitoring of treatment response and safety after treatment.
1 visit for lesion evaluation and safety assessment
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
N
NCI SB Immunotherapy Recruitment Center
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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