Is NCT07672483 recruiting in Bethesda, MD?

Yes, NCT07672483 is currently recruiting participants at its Bethesda, MD location. This relapsed solid tumor malignancies clinical trial is actively enrolling qualified participants.

Is participation in this Bethesda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Relapsed Solid Tumor Malignancies Clinical Trial in Bethesda, MD

Q: How do I join the relapsed solid tumor malignancies clinical trial in Bethesda?

To join this clinical trial in Bethesda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Relapsed Solid Tumor Malignancies Study in Bethesda

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.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

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 and --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. Note: Participants who are unable to walk because of paralysis, but who are able to maintain supine position independently in a wheelchair, will be considered ambulatory for the purpose of performance status.

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. Note: WOCBP is defined as any woman who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. Men able to father a child must agree to use a highly effective method of contraception (surgical sterilization, abstinence or man may request that partner uses the highly effective form of contraception to fulfill this requirement) at the study entry and up to 7 months after the last dose of study drugs. Men able to father a child must not freeze or donate sperm within the same period.

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 Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT07672483) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Relapsed Solid Tumor Malignancies Treatment Options in Bethesda, MD

If you're searching for relapsed solid tumor malignancies treatment options in Bethesda, MD, this clinical trial (NCT07672483) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced relapsed solid tumor malignancies specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all relapsed solid tumor malignancies clinical trials near you to find additional studies recruiting in your area.

Relapsed Solid Tumor Malignancies Clinical Trial in Bethesda, MD

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