Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT02789228
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
60 Years
Study:
NCT02789228
Study Brief:
Protocol Section:
NCT02789228