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

Conditions

• Refractory Solid Tumor Malignancies
• Relapsed Solid Tumor Malignancies

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• IL-12 GEMys — BIOLOGICAL
  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.
• Cyclophosphamide — DRUG
  Lymphodepletive chemotherapy administered as 30 mg/kg IV infusion over 1 hour daily on days -6 and -5.
• Fludarabine — DRUG
  Lymphodeleptive chemotherapy administered as 25 mg/m\^2 IV infusion over 30 minutes on days -6 through -2.
• Cetuximab — DRUG
  Administered as IV infusion at 500 mg/m\^2, if needed.

Study Details

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.

Key Dates

Start date

Jul 2, 2026

Status verified

Jun 2026

Primary completion

Jan 15, 2028

Completion

Jan 15, 2029

Study Design

Enrollment

95 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  Escalating/de-escalating doses of IL-12 GEMys with or without conditioning (cyclophosphamide and fludarabine)
• Experimental: Arm 2
  RP2D of IL-12 GEMys with or without conditioning (cyclophosphamide and fludarabine)

Primary Outcome Measure

Part A (Escalation): Determine the recommended phase 2 dose (RP2D) of IL-12 [ Time Frame: 0-28 Days ]

Central Contacts

• NCI POB Solid Tumor Referral Team
  (240) 858-7012
  [email protected]
• Rosandra N Kaplan, M.D.
  (240) 760-6198
  [email protected]

Locations (1)

Find similar trials in Bethesda, MD