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

NCT07672483 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-08-11

No results posted yet for this study

Summary

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.

Conditions

  • Relapsed Solid Tumor Malignancies
  • Refractory Solid Tumor Malignancies

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Rosandra N Kaplan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-16
Primary Completion
2028-01-15
Completion
2029-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07672483 on ClinicalTrials.gov