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.
Additional locations may be listed on ClinicalTrials.gov for NCT02830724.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Active
Contact: NCI/Surgery Branch Recruitment Cente
Phone: 866-820-4505
Background:
- We generated a chimeric antigen receptor (CAR) that engages CD70 using its natural
ligand CD27, as the binding moiety. Transducing peripheral blood lymphocytes (PBL)
with this CAR conveys major histocompatibility complex (MHC)-independent recognition
of CD70-expressing target cells, which include renal cell carcinoma and other
cancers.
- In co-cultures with CD70+ target cells, anti-hCD70 CAR transduced T cells secrete
significant amounts of IFN-gamma with high specificity.
Objectives:
Primary objectives:
- Phase I: Determine the safety of administering PBL transduced with anti-hCD70 CAR in
concert with preparative lymphodepletion and high dose interleukin-2 (IL-2;
aldesleukin).
- Phase II: Determine if anti-hCD70 CAR-transduced PBL can mediate the regression of
CD70 expressing tumors.
Eligibility:
- Patients must be/have:
- Age >= 18 years and <= 72 years
- Metastatic or unresectable CD70-expressing cancer which has progressed after
standard therapy
- Patients may not have:
- Allergies or hypersensitivities to high-dose aldesleukin, cyclophosphamide, or
fludarabine.
Design:
- This is a phase I/II, single center study of PBL transduced with anti-hCD70 CAR in
patients with measurable, unresectable cancer expressing CD70.
- PBMC obtained by leukapheresis will be cultured in the presence of anti-CD3 (OKT3)
and aldesleukin in order to stimulate T-cell growth.
- Transduction is initiated by exposure of these cells to retroviral vector
supernatant containing replication-incompetent virus encoding the anti-hCD70 CAR.
- All patients will receive a non-myeloablative, lymphodepleting preparative regimen
of cyclophosphamide and fludarabine.
- On day 0, patients will receive PBL transduced with the anti-hCD70 CAR and will then
begin high-dose aldesleukin.
- A complete evaluation of lesions will be conducted approximately 6 weeks (plus or
minus two weeks) after treatment.
- The study will be conducted using a Phase I/II optimal design, with two separate
cohorts for the Phase II component:Cohort 2a, patients with CD70-expressing clear
cell renal cell carcinoma (RCC), and Cohort 2b, patients with a CD70-expressing
non-RCC malignancy (solid tumors only).
- A total of up to 124 patients may be required; approximately 38 patients in the
Phase I portion of the study and 43 (41, plus an allowance of up to 2 non-evaluable)
patients in each cohort of the Phase II portion of the study.
Lead OrganizationNational Cancer Institute
Principal InvestigatorJames Chung-Yin Yang