Clinical Trial Of Autologous, Genetically-modified Tumor-infiltrating Lymphocytes (Tils) To Treat Solid Cancers
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer
Doctors at the NIH Clinical Center seek patients with solid cancer of one of the following, with metastasis
- gastrointestinal and genitourinary cancers
- breast, ovarian, and other solid cancers
- non-small cell lung cancer (NSCLC) or
Study participants will receive an investigatory treatment that removes white blood cells, genetically alters them to attack the patients’ own cancer, then stay in the hospital 1 to 3 weeks for return of those cells and a recovery period. Chemotherapy will be provided before the white blood cells are returned. After these treatments, the participant will undergo screening tests every few months and then at less frequent intervals, looking for evidence that the treatment shrinks tumors. Preparation may include a biopsy or surgery to obtain tumor cell samples.
- Have one of the specific type of cancers investigated with metastasis
- Be between the ages of 18 to 70 years
- Not be pregnant
- Using birth control from the time of enrollment on this study and for four months after treatment.
THE STUDY INVOLVES:
- Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm. An IV catheter will be placed in the chest.
- Care at home over 6-12 weeks.
- Stopping therapy for 4-6 weeks while their cells are changed in a lab.
- Hospital stay for 1 week to get chemotherapy by IV.
- Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer.
- Recover in the hospital for 1-2 weeks. Participants will get drugs and have blood and urine tests.
- Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined.
The NIH Clinical Center is America’s Research Hospital is located in Bethesda, Maryland, on the Metro red line (Medical Center stop). <link to directions>
NIH Clinical Center contact NCI/Surgery Branch Recruitment Center | Ellen Bodurian
1-866-820-4505 [email protected] (refer to study NCT03412877)
TTY for the deaf or hard of hearing: 1-866-411-1010
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