IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)
About this trial
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.
Eligibility criteria
Qualifiers
Relapsed or refractory solid tumor malignancies for whom standard measures do not exist or are no longer effective. Must have histologic confirmation of original diagnosis or relapse.
Participants must have evaluable (measurable or not measurable) disease.
be willing to undergo mandatory pre- and post-treatment tumor biopsies. Tumor tissue should either be taken from non-target lesions or from target lesions where sampling can be done without impacting lesion measurement
Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy and close monitoring for over 3 months shows no active progression.
Disqualifiers
Participants with history of primary CNS tumors or leptomeningeal disease.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, fludarabine, IL-12, or other agents used in the study.
Concurrent untreated opportunistic infections as evidenced by history, blood test or imaging at screening.
Active systemic infections requiring anti-infective treatment.
Trial design
Treatments tested in this trial
- IL-12 GEMys
- Cyclophosphamide
- Fludarabine
- Cetuximab
Treatment groups
95 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov