Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors (NCT05238792) | Clinical Trial Compass
RecruitingPhase 1
Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors
United States24 participantsStarted 2021-11-17
Plain-language summary
This is an open-label phase I dose-escalation study to evaluate the safety of partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation for pediatric and adult patients with high-risk solid tumors due to the presence of refractory, relapsed and/or minimal residual detectable disease following conventional therapy (e.g., chemotherapy, surgery, radiation, autologous stem cell transplant, or targeted therapy).
Who can participate
Age range
1 Year – 70 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:
* Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.
* HLA type and match through at least one allele with antigen-specific activity.
* Following conventional therapy: refractory disease, residual detectable disease, or relapsed disease.
* Age \>= 1 year and \<70 years
* Patient or parent/guardian capable of providing informed consent.
* No systemic corticosteroid exposure within 1 week of initiating protocol treatment.
* Karnofsky/Lansky score of ≥50%.
* For participant with history of total body irradiation (TBI), radiation to thorax, or treatment with cardiotoxic chemotherapy (anthracycline or equivalent): Left ventricular ejection fraction (LVEF) \>50% OR left ventricular fractional shortening (FS) \>27% (may be performed within the last 12 months, and after completion of such treatment/s)
* Hemoglobin \>7.0 g/dL (level can be achieved with transfusion).
* Direct bilirubin ≤2.5 mg/dL or 3x ULN (whichever is higher).
* Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤5 x the upper limit of normal for age.
* Serum creatinine \<1.0 mg/dL or 2x the upper limit of normal for age (whichever is higher).
* Pulse oximetry of \>90% on room air.
* Respiratory rate:
* \<30 breaths per minute for patients aged \<18 years
* \<25 breaths per minute for patients aged ≥18 years
* Respira…
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
To determine the safety of administering partially HLA-matched TAA-T cells