Adoptive Cell Therapy Using Cancer Specific CD8+ Tumor Infiltrating Lymphocytes in Adult Patients… (NCT05902520) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Adoptive Cell Therapy Using Cancer Specific CD8+ Tumor Infiltrating Lymphocytes in Adult Patients With Solid Tumors
United States18 participantsStarted 2023-06-19
Plain-language summary
The subject of this study is the adoptive transfer of selected autologous tumor infiltrating lymphocytes (TIL) after in vitro expansion for the treatment of solid tumor malignancies. The TIL selection process is based on evidence showing that CD8+ TIL which co-express both CD39 and CD103 harbor the bulk of tumor-reactivity and that the remaining CD8 TIL is mainly composed of non-tumor reactive bystander cells. All of the expanded TIL that are produced (1-40 billion are expected) will be delivered in the form of a cell suspension to the participants by intravenous infusion. It is proposed that these selected TIL will produce a more potent and efficacious treatment of late-stage cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Participants must have signed and dated a current IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. Patients must have the ability to understand a written informed consent document, and the willingness to sign it.
* Consent must be obtained before the performance of any protocol related procedures that are not part of normal patient care.
* Patients must have histologically confirmed advanced solid tumor that is metastatic or unresectable and who have progression of disease on standard therapy. Historical pathology reports will suffice to meet this criterion, repeat biopsy confirmation is not needed.
* Age \>18 years
* At least one tumor nodule greater than or equal to 1 cm in long axis diameter amenable to surgical harvest as an out-patient procedure for DP CD8 TIL production.
* Patients must meet the laboratory criteria below within 28 days prior to the first dose of study treatment:
* Adequate Bone Marrow Function: WBC \>3,000/mcL; Absolute neutrophil count \>1,500/mcL; Hemoglobin \> 8 gm/dL; Platelets \>100,000/mcL
* Adequate hepatic function: total bilirubin; ≤ 2.0 mg/dL except in patients with Gilbert's Syndrome who must have a total bilirubin ≤ 3.0 mg/dL; AST(SGOT) \< 2.5 X institutional upper limit of normal; ALT(SGPT) \< 2.5 X institutional upper limit of normal
* Adequate renal function: Serum creatinine \< 1.5 x ULN, unless creatinine clearance ≥ 40 mL/min (measured or calculated …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of DP CD8 TIL
Timeframe: 12 weeks after cell infusion, then per PI discretion