Background:
Small cell lung cancer (SCLC) is the deadliest form of lung cancer. Extrapulmonary neuroendocrine cancer (EPNEC) is a similar type of cancer that develops anywhere other than the lungs. EPNEC is also deadly. B7-H3 is a protein often found in SCLC and EPNEC tumor cells. Researchers can modify a person s own T cells, or immune cells, to target B7-H3. When these modified T cells are returned to the body-a treatment called B7-H3 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells.
Objective:
To test B7-H3 CAR T cell therapy in people with SCLC or EPNEC.
Eligibility:
People aged 18 years and older with SCLC or EPNEC that either did not respond or returned after treatment.
Design:
Participants will be screened. They will have blood tests and tests of their heart function. They will have imaging scans.
Participants will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be altered to make them attack cells with B7-H3.
Participants will be in the hospital for at least 15 days. They will receive chemotherapy drugs to prepare their body for the treatment. These drugs will be given through a tube attached to a needle inserted into a vein.
The modified T cells will be infused through a vein. Participants will remain in the hospital until they are well enough to go home.
Follow-up visits will continue for 15 years....
Age >=18 years old.
Histologically confirmed small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancers (EP-NEC) that has recurred following or is refractory to first-line therapy. Note: small cell cancers of non-lung primary sites are also eligible.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.
Pulse oximetry >= 90 percent on room air.
History of anaphylactic reactions attributed to anti-B7-H3 antibodies or compounds of similar chemical or biologic composition to autologous B7-H3 CAR T cells, cyclophosphamide, fludarabine, or other agents used in this study.
Positive serology for HIV.
Active HBV infection as demonstrated by test for hepatitis B surface antigen (HBsAg).
Positive serology for HCV.
National Cancer Institute (NCI)
Lead sponsor