IL-12 Genetically Engineered Myeloid Cells for Relapsed, Refractory Solid Tumors
This study is testing a new cell therapy called IL-12 GEMys for people with solid tumors that have returned or not responded to previous treatments. IL-12 GEMys are your own immune cells (myeloid cells) that have been specially modified to produce a protein called IL-12, which helps your immune system fight cancer. You would also receive chemotherapy drugs, Cyclophosphamide and Fludarabine, before the cell therapy. The main goals are to find the safest and most effective dose of IL-12 GEMys and to see if this treatment increases IL-12 or IFNy levels in your tumors. You may be eligible if you are 18 or older and have a solid tumor that has relapsed (returned) or is refractory (not responding to treatment).
- Study design
- This is an interventional study with a planned enrollment of 95 participants. It has two parts: Part A to find the right dose, and Part B to further evaluate the treatment.
- What's involved
- You will undergo screening, including a physical exam, blood tests, heart and lung function tests, and imaging scans. If in Part B, you must be willing to have tumor biopsies before and after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure the recommended dose within 28 days and assess changes in tumor markers at 1 week after treatment.
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NCT07672483
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~95 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:IL-12 GEMysCyclophosphamideFludarabineCetuximab
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A (Escalation): Determine the recommended phase 2 dose (RP2D) of IL-12
Measured over 0-28 Days
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Rosandra N Kaplan, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Part B only: Participants must:
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
have disease amenable to biopsy to allow to perform pre- and post-tumor biopsies.
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.
At least one prior cancer treatment when upfront standard therapy exists. Note: There is no limit to the number or type of prior treatment regimens.
The indicated time must have elapsed since any systemic anti-cancer therapy prior to leukapheresis.
Age \>= 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
Participants must have adequate organ and marrow function as defined below:
Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3
Platelet count \>= 100,000/mm\^3
Hemoglobin (Hgb) \>= 8 g/dL (transfusion independent)
Prothrombin time (PT) \<= 1.5 X institutional upper limit of normal (ULN) (Part B only, participants undergoing biopsy)
Creatinine clearance \>= 60 mL/minute/1.73m\^2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
Aspartate Aminotransferase (AST) \<= 3 X institutional ULN
Alanine Aminotransferase (ALT) \<= 3 X institutional ULN
Total bilirubin \<= 1.5 institutional ULN. Note: In the case of Gilbert's syndrome total bilirubin \<= 3 X ULN
Serum albumin \>= 2.7 g/dL
Ejection fraction of \>= 45% and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram (ECHO).
QTc interval \< 480 msec
Oxygen saturation \>92% on room air at rest
Participants with a clinical history of prolonged smoking (\>= 10 pack-years), lung disease, or current or recent history of respiratory symptoms must have a forced expiratory volume in the first second (FEV1) \> 50%.
Participants seropositive for human immunodeficiency virus (HIV) must have an undetectable HIV viral load.
Participants seropositive for Hepatitis C virus (HCV) must have an undetectable HCV viral load
Participants positive for Hepatitis B surface antigen (HbsAg) must have an undetectable Hepatitis B virus (HBV) viral load.
Women of childbearing potential (WOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \[IUD\], abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy.
Nursing participants must be willing to discontinue nursing from study treatment initiation through 12 months after the last dose of the study drug(s).
Ability and willingness of participant to enroll on protocol 15-C-0028, Follow-Up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials after 5 years.
Ability of the participant to understand and the willingness to sign a written informed consent document.
Exclusion
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.
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease) or secondary/acquired immunodeficiency requiring steroids or other non-steroid immunosuppressive agents.
History of clonal hematopoiesis of indeterminate potential (CHIP) or myelodysplasia/myelodysplastic syndrome (MDS) or monoclonal gammopathy of undetermined significance (MGUS).
Participants with symptomatic pleural effusions requiring intervention or with recent history (within 3 months) of pleural effusions that required intervention.
Participants with ischemic symptoms (may include chest pain/pressure, shortness of breath, nausea, vomiting, sweating, and/or pain in the neck, shoulder, jaw or arm) confirmed by stress test OR a history of coronary revascularization (unless the participant has a normal cardiac stress test after revascularization and within 12 months prior to leukapheresis).
Any form of diagnosed autoimmune disease requiring immune suppression as well as participants with active autoimmune skin diseases such as psoriasis or any history of active systemic autoimmune disease (e.g., Crohn's, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression/systemic disease-modifying agents within the last 2 years. Exceptions will be allowed for vitiligo and hypothyroidism that has been stable on thyroid replacement medications for \> 6 weeks prior to leukapheresis.
Any participant who developed autoimmunity (\>= grade 3 per CTCAE v. 6.0) with checkpoint inhibitor use. Note: Exceptions will be allowed for vitiligo and hypothyroidism that has been stable on thyroid replacement medications for \> 6 weeks prior to leukapheresis.
Participants who have a major surgical procedure, other than for diagnosis, within 4 weeks prior to leukapheresis or anticipated to need a major surgical procedure during the study.
History of prior solid organ transplantation.
Participants that require urgent therapy due to tumor mass effects or spinal cord compression within 2 weeks prior to leukapheresis.
Any investigational therapy within 2 weeks prior to leukapheresis.
Pregnancy confirmed with Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in WOCBP at screening. Note: In case of a suspected false-positive serum or urine test result, additional evaluation must be done to rule out pregnancy.
Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history, physical exam, or situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study.
What this trial measures
- Part A (Escalation): Determine the recommended phase 2 dose (RP2D) of IL-120-28 Days
Maximum dosage of GEMys IL-12 with which no more than 1 participant experience dose limiting toxicity as assessed by grade of adverse event
- Part B (Expansion): Assess whether IL-12 or IFNy levels, or both increase in tumors post treatment at the RP2D1 week
Increased IL-12 and/or IFNy levels and IL-12 production as measured by ELISA, using a paired t-test or Wilcoxon signed rank test