Status:
RECRUITING
Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients with High Risk Solid Tumors
Lead Sponsor:
Children's National Research Institute
Conditions:
Solid Tumor
Eligibility:
All Genders
6-70 years
Phase:
PHASE1
Brief Summary
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-...
Detailed Description
In this dose escalation trial, three dose levels, with two arms dependent on age, will be tested for safety. Arm A will enroll patients age ≥18 years and \<70 years and Arm B will enroll patients age ...
Eligibility Criteria
Inclusion
- PARTICIPANT INCLUSION CRITERIA
- RECIPIENT SCREENING INCLUSION CRITERIA
- Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical reference: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcoma, and osteosarcoma.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
- Arm B: age ≥6 years to \<18 years
- Patient or parent/guardian capable of providing informed consent.
- RECIPIENT INCLUSION CRITERIA FOR INITIAL TAA-T ADMINISTRATION AND FOR SUBSEQUENT INFUSION
- No systemic steroid exposure within 1 week of TAA-T infusion.
- Karnofsky/Lansky score of ≥50% (see Appendix 4).
- 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).
- Hemoglobin \>7.0 g/dL (level can be achieved with transfusion).
- Bilirubin ≤2.5 mg/dL.
- Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤5 x 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.
- Negative pregnancy test in female patient of childbearing age.
- Agree to use contraceptive measures during study protocol participation (when age appropriate).
- Patients receiving lymphodepleting chemotherapy must have:
- Absolute neutrophil count (ANC) \>1000 /ul.
- Platelet count \>75,000 /ul.
Exclusion
- PARTICIPANT EXCLUSION CRITERIA RECIPIENT SCREENING EXCLUSION CRITERIA
- 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.
- RECIPIENT EXCLUSION CRITERIA FOR INITIAL AND SUBSEQUENT TAA-T INFUSION
- 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.
- For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to TAA-T infusion.
- 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.
- Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days prior to TAA-T infusion.
- For patients receiving lymphodepleting chemotherapy: exposure to chemotherapy or immunomodulatory medications within the last 2 weeks prior to treatment.
- Pregnant or lactating females.
Key Trial Info
Start Date :
November 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05238792
Start Date
November 17 2021
End Date
October 1 2027
Last Update
December 31 2024
Active Locations (1)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010