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NCT02789228

PHASE1

Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors

Sponsor: Children's National Research Institute

View on ClinicalTrials.gov

Summary

Patients with high-risk solid tumors, those that are refractory to standard up front therapy or relapse after completion of therapy, have a very poor prognosis despite attempts to induce remission with salvage regimen. Novel therapies are critical for this patient population with high-risk cancer. The ability of tumors to be recognized and lysed by the immune system offers a unique opportunity to aid in tumor eradication by expanding and activating these anti-tumor cells. Through this ability to harness sophisticated and specific immunotherapy, residual or relapsed disease that is resistant to chemotherapy and/or radiotherapy could be eradicated. Prior studies have suggested both safety of expanded specific T cells and efficacy in the setting of melanoma, lymphoma or viral eradication. While this therapy has previously been limited by the versatility of the tumor to down-regulate antigens and evade a single immune-target, the use of multi-antigen specific T cells may permit better and more durable anti-tumor immunity. Thus, the investigators propose to infuse these specific multi-antigen anti-tumor T lymphocytes into patients with high risk solid tumors. This trial will be conducted to demonstrate safety of these cells and generate efficacy and biology data that may be important for future studies that may enhance tumor immunotherapy.

Key Details

Gender

All

Age Range

6 Months - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2016-10-12

Completion Date

2027-12

Last Updated

2026-03-19

Healthy Volunteers

Conditions

Solid Tumors

Interventions

BIOLOGICAL

Tumor associated antigen lymphocytes (TAA-CTL)

This protocol is designed as a phase I dose-escalation study. In each treatment group (A and B), patients will be enrolled to one of the following TAA-T dose levels: Dose Level One: 1 x 107 cells/m2 Dose Level Two: 2 x 107 cells/m2 Dose Level Three: 4 x 107 cells/m2

Inclusion Criteria: Recipient procurement inclusion criteria * Diagnosis of high-risk solid tumors: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcomas, osteosarcoma, adenocarcinoma, and esophageal carcinoma and renal cell carcinoma. * Refractory disease, residual detectable disease following conventional therapy or relapsed disease. * 6 months to 60 years of age at enrollment.\* * Karnofsky/Lansky score of ≥ 50%.\* * Absolute neutrophil count (ANC) greater than 500/µL. \* * Absolute lymphocyte count (ALC) greater than 1000/µL.\* * Bilirubin ≤ 2.5 mg/dL. \* * Aspartate aminotransferase (AST)/ Alanine transaminase (ALT) ≤ 5x the upper limit of normal for age. \* * Serum creatinine \< 1.0 mg/dL or 2 x the upper limit of normal for age (whichever is higher).\* * Pulse oximetry of \> 90% on room air.\* * Agree to use contraceptive measures during study protocol participation (when age appropriate).\* * LVEF \> 50% or LVSF \> 27 % if history of total body irradiation (TBI). * Patient or parent/guardian capable of providing informed consent. Exclusion Criteria: Recipient Procurement exclusion criteria * Patients with uncontrolled infections * Patients with active HIV * Current evidence of GVHD \> grade 2 or chronic GVHD manifestations: bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis. * Pregnant or lactating females * Prior immunotherapy with an investigational agent within the last 28 days prior to procurement Recipient Inclusion to administer cells: * Steroids less than 0.5 mg/kg/day prednisone (or equivalent). * Karnofsky/Lansky score of ≥ 50% %. * Bilirubin ≤ 2.5 mg/dL. * AST/ALT ≤ 5x 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. * Patients receiving lymphodepleting chemotherapy must have: ANC \>750 /uL Platelet count \>75,000 /uL Recipient Exclusion to administer cells: * Patients with uncontrolled infections * Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal antibodies within 28 days prior to TAA-T cell infusion * Acute GVHD \> grade 2 or chronic GVHD manifestations: bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis * Pregnant or lactating females

Locations (1)

Children's National Medical Center

Washington D.C., District of Columbia, United States