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New treatment option for Solid Tumor
Official title Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors
ClinicalTrials.gov ID: NCT05238792
What this study is testing
What is Tumor-associated antigen-specific T cell (TAA-T)?
Tumor-associated antigen-specific T cell (TAA-T) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 70
You may be able to join if
- PARTICIPANT RECIPIENT SCREENING Diagnosis of high-risk solid tumors known to express at least 2 targeted antigens by either histology or historical...
- 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
You likely can't join if
- 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...
- Patients with uncontrolled infections. Uncontrolled infections are defined as bacterial, fungal, or viral infections with either clinical signs of...
See the full eligibility criteria
- PARTICIPANT RECIPIENT SCREENING 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...
- 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 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.