drugset / Trial / NCT02830724

Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers

NCT02830724

Phase 1/2 Recruiting 124 enrolled National Cancer Institute (NCI)
Non-randomizedSequentialOpen-labelTreatment

Summary

Background: In a new cancer therapy, researchers take a person s blood, select a certain white blood cell to grow in the lab, and then change the genes of these cells using a virus. The cells are then given back to the person. This is called gene transfer. For this study, researchers will modify the person s white blood cells with anti-CD70. Objectives: To see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain the treatment is safe. Eligibility: Adults age 18 and older diagnosed with cancer that has the CD70-expressing cancer. Design: Participants will be screened with medical history, physical exam, scans, and other tests. They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. Eligible participants will have an intravenous catheter placed in their upper chest. Over several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in the hospital. Participants will take an antibiotic for 6 months after treatment. They will repeat leukapheresis. Participants will visit the clinic every 1-3 months for the first year after treatment, every 6 months for the second year, and then as determined by their physician. Follow-up visits will take 1-2 days. At each visit, participants will have lab tests, imaging studies, and a physical exam. Throughout the study, blood will be taken and participants will have many tests to determine the size and extent of their tumor and the treatment s impact.

Timeline

Start
2017-04-06
Primary completion
2029-01-01
Completion
2030-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Anti-hCD70 CAR transduced PBL Cell therapy Intravenous
Background Cyclophosphamide Other / unclassified 15 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 30 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background aldesleukin Protein / enzyme biologic 720000 iu/kg Intravenous