NCT02789228Active, not recruitingPhase 1
Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 24 May 2016
- Start date
- 12 Oct 2016
- Primary completion date
- 18 Apr 2022
- Lead sponsor
- Children's National Research Institute
- Diseases
- Childhood cancers
- NCT number
- NCT02789228
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 36
- From 12 Oct 2016 to the primary completion date, 18 Apr 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal antibodies within 28 days prior to TAA-T cell infusion
Other illness
- 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.
- Patients with uncontrolled infections
- Acute GVHD \> grade 2 or chronic GVHD manifestations: bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis
Lab values
- 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).
- Patients receiving lymphodepleting chemotherapy must have:
- ANC \>750 /uL Platelet count \>75,000 /uL
- Recipient Exclusion to administer cells:
Other
- Recipient Procurement exclusion criteria
- Pregnant or lactating females
- Karnofsky/Lansky score of ≥ 50% %.
- Pulse oximetry of \> 90% on room air.
- Pregnant or lactating females
Who the study is looking for
- 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.
Age in the registry: 6 months to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.