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New treatment option for Melanoma
Official title Clinical Trial of CD40L-augmented TIL for Patients With Advanced Melanoma
ClinicalTrials.gov ID: NCT06961357
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase I/II clinical trial of a single dose of CD40L-augmented TIL administered in patients with advanced melanoma (Cohort 1: Cutaneous acral melanoma, cutaneous non-acral melanoma, (n=26); Cohort 2: Mucosal melanoma, uveal melanoma, (n=10)). Patients will undergo an excision of a readily accessible tumor for preparation of TIL.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically confirmed, unresectable (Stage III/IV) or metastatic melanoma as follows: Cutaneous, non-acral, melanoma...
- Participants must have failed, be refractory to, or unable to tolerate at least one line of standard of care in the opinion of the Investigator. For...
- Any systemic therapy, including anti-cancer monoclonal antibodies, must have been completed at least 4 weeks from the start of lymphodepleting...
- Participants must be ages ≥18. Additionally, participants who are ≥ 65 years of age may need to undergo a cardiology evaluation including a cardiac...
- ECOG performance status of 0 or 1.
You likely can't join if
- Participants, regardless of age, who have a current or past medical history of ischemic heart disease, or clinically significant atrial or...
- Participants with either a primary immunodeficiency disorder (i.e., severe combined immunodeficiency syndrome) or acquired immunodeficiency disorders...
- Pregnant women are excluded from this study because the agents used in this study have teratogenic or abortifacient effects. Because there is an...
- Participants taking systemic steroid therapy (other than replacement therapy or prednisone equivalent of ≤10mg daily) or therapy with any...
- Participants who have a history of severe immediate hypersensitivity reaction to the study agents including cyclophosphamide, fludarabine, or IL-2 or...
- Participants with a left ventricular ejection fraction (LVEF) ≤ 45% or New York Heart Association (NYHA) functional classification \> 1.
See the full eligibility criteria
Who can join
- Participants must have histologically confirmed, unresectable (Stage III/IV) or metastatic melanoma as follows: Cutaneous, non-acral, melanoma (including melanoma of unknown primary); Cutaneous acral melanoma; Mucosal...
- Participants must have failed, be refractory to, or unable to tolerate at least one line of standard of care in the opinion of the Investigator. For participants with cutaneous non-acral melanoma, standard of care...
- Any systemic therapy, including anti-cancer monoclonal antibodies, must have been completed at least 4 weeks from the start of lymphodepleting therapy, and any prior therapy-related AEs must have resolved to Grade ≤ 1...
- Participants must be ages ≥18. Additionally, participants who are ≥ 65 years of age may need to undergo a cardiology evaluation including a cardiac stress test or coronary computed tomography after which they must be...
- ECOG performance status of 0 or 1.
- Participants must have adequate organ and marrow function as defined within the protocol.
- Seronegative for Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C (HCV) antibody (if HCV antibody positive, must be tested for HCV RNA, which must be negative to be eligible).
- Participants with brain metastases are eligible provided that the brain metastases have been successfully treated with stereotactic radiosurgery or resection and clinically stable for at least 4 weeks (±14 days). Note...
- Women of child-bearing potential must have a negative pregnancy test.
- The effects of CD40L-augmented TIL on the developing human fetus are unknown. For this reason and because TIL agents, as well as other therapeutic agents used in this trial including IL-2 are known to be teratogenic...
- Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
- Participants should have at least one surgically accessible lesion for tumor harvest for preparation of TIL, and at least one RECIST v1.1 measurable lesion after tumor harvest to follow for response assessment. Note...
What rules you out
- Participants, regardless of age, who have a current or past medical history of ischemic heart disease, or clinically significant atrial or ventricular rhythm abnormality are excluded unless they undergo a cardiac stress...
- Participants with either a primary immunodeficiency disorder (i.e., severe combined immunodeficiency syndrome) or acquired immunodeficiency disorders (such as HIV/AIDS).
- Pregnant women are excluded from this study because the agents used in this study have teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary...
- Participants taking systemic steroid therapy (other than replacement therapy or prednisone equivalent of ≤10mg daily) or therapy with any immunosuppressive medications such as mycophenolate mofetil (MMF). Participants...
- Participants who have a history of severe immediate hypersensitivity reaction to the study agents including cyclophosphamide, fludarabine, or IL-2 or any of their constituents.
- Participants with a left ventricular ejection fraction (LVEF) ≤ 45% or New York Heart Association (NYHA) functional classification \> 1.
- Forced expiratory volume (FEV1) ≤ 60% of predicted value and DLCO (corrected) \< 60% of predicted value. Participants who underwent pulmonary function testing within 6 months of screening may omit PFTs if they...
- Participants who, in the opinion of the Investigator, have a medical condition that would subject the patient to prohibitive risk by participation in this study, or who may be unable to safely complete tumor harvest...
- Participants with active infections requiring antibiotics.
- Participants with active autoimmune diseases currently requiring systemic treatment with immunosuppressive doses of corticosteroids (\>10 mg of prednisone-equivalent daily dosing), immunosuppressive biologic agents, or...
- Patients who received prior live cell therapy are excluded, unless express written permission is provided by the clinical PI.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.