Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6-70
SponsorChildren's National Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.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

Disqualifiers

Patients with known human immunodeficiency virus (HIV) infection.

Pregnant or lactating females.

Patients who have undergone previous allogeneic stem cell transplant.

Patients who have undergone previous autologous stem cell transplant within the past 60 days.

Trial design

Treatments tested in this trial

  • Tumor-associated antigen-specific T cell (TAA-T)

Treatment groups

36 Participants
are divided into 2 treatment groups