Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07672483
PHASE1

IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Background: Myeloid cells are a type of immune cell found in most tumors. Interleukin 12 (IL-12) is a protein the immune system makes that can help kill tumor cells. Researchers want to know if myeloid cells that have been genetically engineered to produce IL-12 (IL-12 GEMys) can 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 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.

Official title: Phase I Trial of IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

95

Start Date

2026-07-05

Completion Date

2029-01-15

Last Updated

2026-06-30

Healthy Volunteers

No

Interventions

BIOLOGICAL

IL-12 GEMys

Cell therapy generated from autologous CD34+ cells. Administered on Day 0 as an IV infusion not to exceed 20ml/kg or 40ml/kg depending on DMSO levels.

DRUG

Cyclophosphamide

Lymphodepletive chemotherapy administered as 30 mg/kg IV infusion over 1 hour daily on days -6 and -5.

DRUG

Fludarabine

Lymphodeleptive chemotherapy administered as 25 mg/m\^2 IV infusion over 30 minutes on days -6 through -2.

DRUG

Cetuximab

Administered as IV infusion at 500 mg/m\^2, if needed.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States