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 States36 participantsStarted 2021-11-17
Plain-language summary
This is a 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 for patients with high-risk solid tumors due to the presence of refractory, relapsed and/or minimal residual detectable disease following conventional therapy. Conventional therapy may include chemotherapy, surgery, radiation, autologous stem cell transplant, or targeted therapy.
Who can participate
Age range6 Years – 70 Years
SexALL
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Inclusion Criteria:
PARTICIPANT INCLUSION CRITERIA
RECIPIENT SCREENING 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* Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.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.
* Refractory disease, residual detectable disease following conventional therapy or relapsed disease.
* Arm A: age ≥18 years and \<70 years
* Arm B: age ≥6 years to \<18 years
* Patient or parent/guardian capable of providing informed consent.
RECIPIENT INCLUSION CRITERIA FOR INITIAL TAA-T ADMINISTRATION AND FOR SUBSEQUENT INFUSION
* No systemic steroid exposure within 1 week of TAA-T infusion.
* Karnofsky/Lansky score of ≥50% (see Appendix 4).
* Left ventricular ejection fraction (LVEF) \>50% or left ventricular systolic dysfunction (LVSD) \>27% if history of total body irradiation (TBI) (may be performed within the last 6 months).
* Hemoglobin \>7.0 g/dL (level can be achieved with transfusion).
* Bilirubin ≤2.5 mg/dL.
* 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.
* Negative pregnancy test in female patient of childbearing age.
* Agree to use contraceptive measures during study protocol particip…