NCT07672483
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
레지스트리 요약
- 진행 상태
- 모집 전 (NOT_YET_RECRUITING)
- 질환/조건
- Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
- 시험 유형
- 중재 연구 (INTERVENTIONAL)
- 단계
- Phase 1
- 목적
- 치료
- 중재 유형
- 생물학적 제제, 약물
- 개입·치료
- IL-12 GEMys, Cyclophosphamide, Fludarabine, Cetuximab
- Lead Sponsor
- National Cancer Institute (NCI) (NIH)
캐시 시각: 2026-10-03 08:59:59
요약
Background:
Myeloid cells are a type of immune cell found in most tumors. Interleukin 12 (IL-12) is a protein that helps the immune system kill tumor cells. Researchers want to know if myeloid cells that have been genetically engineered to produce IL-12 (IL-12 GEMys) can activate the immune system to attack cancer cells in solid tumors.
Objective:
To test IL-12 GEMys in people with cancer.
Eligibility
People aged 18 years and older with cancer that returned or failed to respond to treatment.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans of their tumors. A sample of tumor tissue may be taken.
Participants will have daily injections for few days to prepare them to undergo leukapheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out stem cells. The remaining blood will be returned to the body through a different needle. The collected stem cells will be modified in a lab to create IL-12 GEMys.
Participants will check in to the hospital. They will receive drugs for 5 days to prepare their body for the treatment. Then they will have their own IL-12 GEMys infused through a needle inserted into a vein. They will stay in the hospital until they are well enough to go home. This may be 7 to 14 days or longer.
Some participants may receive a second treatment with IL-12 GEMys within 2 years after the first.
Participants will have follow-up visits for about 5 years. These will include imaging scans and blood tests.
Myeloid cells are a type of immune cell found in most tumors. Interleukin 12 (IL-12) is a protein that helps the immune system kill tumor cells. Researchers want to know if myeloid cells that have been genetically engineered to produce IL-12 (IL-12 GEMys) can activate the immune system to attack cancer cells in solid tumors.
Objective:
To test IL-12 GEMys in people with cancer.
Eligibility
People aged 18 years and older with cancer that returned or failed to respond to treatment.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans of their tumors. A sample of tumor tissue may be taken.
Participants will have daily injections for few days to prepare them to undergo leukapheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out stem cells. The remaining blood will be returned to the body through a different needle. The collected stem cells will be modified in a lab to create IL-12 GEMys.
Participants will check in to the hospital. They will receive drugs for 5 days to prepare their body for the treatment. Then they will have their own IL-12 GEMys infused through a needle inserted into a vein. They will stay in the hospital until they are well enough to go home. This may be 7 to 14 days or longer.
Some participants may receive a second treatment with IL-12 GEMys within 2 years after the first.
Participants will have follow-up visits for about 5 years. These will include imaging scans and blood tests.
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