B7-H3 CAR T Cells for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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....
Who Is on the Research Team?
Anish Thomas, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Apheresis
Participants undergo apheresis for T cell selection and modification
Chemotherapy
Participants receive chemotherapy drugs to prepare their body for the CAR T cell infusion
CAR T Cell Infusion
Modified T cells are infused through a vein, and participants remain in the hospital for monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Autologous B7-H3 CAR T
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Maximum tolerated dose (MTD) or maximum administered dose (MAD) of autologous B7-H3 CAR T cells.
Escalating doses of autologous B7-H3 CAR T cells.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
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