RECRUITING

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

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Conditions

Solid Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase I Research Study Utilizing Allogeneic Multi Tumor-Associated Antigen-Specific T Lymphocytes to Advance the Care of Patients With High-Risk Solid Tumors

Quick Facts

Study Start:2021-11-17
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05238792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.
  2. * HLA type and match through at least one allele with antigen-specific activity.
  3. * Refractory disease, residual detectable disease following conventional therapy or relapsed disease.
  4. * Arm A: age ≥18 years and \<70 years
  5. * Arm B: age ≥6 years to \<18 years
  6. * Patient or parent/guardian capable of providing informed consent.
  7. * No systemic steroid exposure within 1 week of TAA-T infusion.
  8. * Karnofsky/Lansky score of ≥50% (see Appendix 4).
  9. * 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).
  10. * Hemoglobin \>7.0 g/dL (level can be achieved with transfusion).
  11. * Bilirubin ≤2.5 mg/dL.
  12. * Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤5 x the upper limit of normal for age.
  13. * Serum creatinine \<1.0 mg/dL or 2x the upper limit of normal for age (whichever is higher).
  14. * Pulse oximetry of \>90% on room air.
  15. * Negative pregnancy test in female patient of childbearing age.
  16. * Agree to use contraceptive measures during study protocol participation (when age appropriate).
  17. * Patients receiving lymphodepleting chemotherapy must have:
  18. * Absolute neutrophil count (ANC) \>1000 /ul.
  19. * Platelet count \>75,000 /ul.
  1. * Patients with known human immunodeficiency virus (HIV) infection.
  2. * Pregnant or lactating females.
  3. * Patients who have undergone previous allogeneic stem cell transplant.
  4. * Patients who have undergone previous autologous stem cell transplant within the past 60 days.
  5. * Patients with uncontrolled infections. Uncontrolled infections are defined as bacterial, fungal, or viral infections with either clinical signs of worsening despite standard therapy. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
  6. * For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to TAA-T infusion.
  7. * For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to TAA-T infusion.
  8. * Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days prior to TAA-T infusion.
  9. * For patients receiving lymphodepleting chemotherapy: exposure to chemotherapy or immunomodulatory medications within the last 2 weeks prior to treatment.
  10. * Pregnant or lactating females.

Contacts and Locations

Study Contact

Amy Hont, MD
CONTACT
202-476-3887
ahoughte@childrensnational.org
Fahmida Hoq, MBBS
CONTACT
202-476-3634
fhoq@childrensnational.org

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-17
Study Completion Date2027-10

Study Record Updates

Study Start Date2021-11-17
Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumor