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CAR T-cell Therapy
TAA-T Cell Therapy for Solid Cancers
Phase 1
Recruiting
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤5 x the upper limit of normal for age
Negative pregnancy test in female patient of childbearing age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that uses the patient's own T cells to target and kill cancer cells.
Who is the study for?
This trial is for patients with high-risk solid tumors like Ewing sarcoma or neuroblastoma, who have not responded well to standard treatments. Participants must be in stable condition without recent steroid use or infections and agree to contraception if applicable. They should match at least one HLA allele with the TAA-T therapy and meet specific health criteria such as adequate organ function.Check my eligibility
What is being tested?
The study tests a new cancer treatment using T cells that target tumor-associated antigens (TAA-T). It's for those whose tumors express certain antigens and haven't improved after conventional therapies. The trial will gradually increase doses to find the safest amount of TAA-T cells that can be given.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune response, such as fever or fatigue, issues from cell infusions like chills or shortness of breath, and complications due to weakened immunity leading to increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver enzymes are within a normal range for my age.
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I am not pregnant.
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My hemoglobin level is above 7.0 g/dL, possibly after a transfusion.
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My kidney function, measured by creatinine, is within the normal range.
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I haven't taken any steroids in the week before my TAA-T infusion.
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My cancer is one of the listed types and tests show it has at least 2 targeted antigens.
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My HLA type matches at least one allele with specific antigen activity.
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I need assistance but can take care of most of my personal needs.
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My disease did not respond to standard treatment, or it came back.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The rate of toxicities after TAA-T infusion
Secondary outcome measures
Anti-tumor activity based on tumor response
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B for patients age ≥6 years and <18 yearsExperimental Treatment1 Intervention
Arm B will enroll patients age ≥6 years and <18 years. TAA-T product will first be administered to patients as monotherapy at dose level 1 to determine safety. Following demonstration of safety in dose level 1, lymphodepleting chemotherapy will be administered prior to the first dose of TAA-Ts on the dose escalation phase (dose levels 2 and 3). The TAA-T product will be assessed for safety and anti-tumor activity.
Group II: Arm A for patients age ≥18 years and <70 yearsExperimental Treatment1 Intervention
Arm A will enroll patients age ≥18 years and <70 years. TAA-T product will first be administered to patients as monotherapy at dose level 1 to determine safety. Following demonstration of safety in dose level 1, lymphodepleting chemotherapy will be administered prior to the first dose of TAA-Ts on the dose escalation phase (dose levels 2 and 3). The TAA-T product will be assessed for safety and anti-tumor activity.
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Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
211 Previous Clinical Trials
208,121 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't received specific immune system treatments in the last 28 days.My blood tests show enough neutrophils and platelets while on chemotherapy.My liver enzymes are within a normal range for my age.I am not pregnant.My hemoglobin level is above 7.0 g/dL, possibly after a transfusion.My kidney function, measured by creatinine, is within the normal range.I had a stem cell transplant using my own cells within the last 60 days.I am on anti-fungal treatment and my fungal infection hasn't worsened in the last 7 days.My heart's pumping ability is good, with an LVEF over 50% or LVSD over 27% if I had total body irradiation.I (or my guardian) can understand and agree to the study's terms.I haven't taken any steroids in the week before my TAA-T infusion.I haven't had chemotherapy or immune system medications in the last 2 weeks.My cancer is one of the listed types and tests show it has at least 2 targeted antigens.My HLA type matches at least one allele with specific antigen activity.I am between 18 and 70 years old for Arm A, or between 6 and 18 years old for Arm B.I need assistance but can take care of most of my personal needs.My disease did not respond to standard treatment, or it came back.I have had a stem cell transplant from a donor.I am on a final treatment for a bacterial infection and have not worsened in the last 7 days.I do not have any infections that are getting worse despite treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A for patients age ≥18 years and <70 years
- Group 2: Arm B for patients age ≥6 years and <18 years
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree is Tumor-associated antigen-specific T cell (TAA-T) hazardous to humans?
"Our team has assigned Tumor-associated antigen-specific T cell (TAA-T) a status of 1, as this is still in its earliest phase and the evidence on efficacy and safety is limited."
Answered by AI
Would I be able to join this experiment?
"Potential participants must possess a solid tumor, be between 6 and 70 years of age, in order to qualify for the trial. As of now, 36 individuals are being recruited."
Answered by AI
How many individuals are being granted access to this trial?
"Affirmative, the information on clinicaltrials.gov shows that this research is currently recruiting participants. This experiment was first published on November 17th 2021 and has been updated as of October 24th 2022. Aspiring enrollees must visit one of the single trial sites to be considered for participation in this study which requires 36 individuals total."
Answered by AI
Is this investigation open to individuals aged 50 and above?
"This research is looking for human subjects aged 6 to 70 years old."
Answered by AI
Are individuals being sought for participation in this trial presently?
"Clinicaltrials.gov states that this clinical trial is actively recruiting patients, with the original post on November 17th 2021 and an update occurring October 24th 2022."
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