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CAR T-cell Therapy
Afamitresgene Autoleucel for Pediatric Cancer
Phase 1 & 2
Recruiting
Led By Fiorella Iglesias Cardenas, MD
Research Sponsored by Adaptimmune
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights
Study Summary
This trial studies safety and effectiveness of an experimental cancer treatment in children 2-21 with advanced cancers.
Who is the study for?
This trial is for children and young adults aged 2-21 with certain advanced cancers like Osteosarcoma or Neuroblastoma. They must have had chemotherapy before, weigh at least 10 kg, and their cancer should be measurable by medical scans. Participants need to have a specific immune system marker (HLA-A*02) and a protein on their tumor cells (MAGE-A4).Check my eligibility
What is being tested?
The study tests afamitresgene autoleucel's safety and effectiveness in treating pediatric patients with advanced cancers that express MAGE-A4. It's for those who are HLA-A*02 positive, focusing on how well they respond to this therapy.See study design
What are the potential side effects?
While the exact side effects of afamitresgene autoleucel aren't listed here, similar treatments can cause immune reactions, infusion-related discomforts, fatigue, nausea, potential infections due to weakened immunity, as well as possible allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence, duration, and severity of Treatment Emergent Adverse Events as assessed by Investigator Evaluation.
Secondary outcome measures
Best overall response (BOR)
Development and validation of an invitro diagnostic (IVD) assay for the screening of tumor antigen expression for regulatory approval.
Duration of Response (DoR)
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Afamitresgene autoleucelExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
AdaptimmuneLead Sponsor
17 Previous Clinical Trials
10,599 Total Patients Enrolled
Fiorella Iglesias Cardenas, MDPrincipal InvestigatorMemorial Sloan Kettering Kids
Tara O'Donohue, MDPrincipal InvestigatorMemorial Sloan Kettering Kids
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 2 and 21 years old.I weigh at least 10 kilograms.My cancer has spread to my brain.I have another cancer that is not fully in remission.I have undergone chemotherapy before.I have been diagnosed with either Synovial Sarcoma, MPNST, Neuroblastoma, or Osteosarcoma.I have a serious heart condition.My genetic test shows I have the HLA-A*02:05 gene.I am HLA-A*02 positive.My tumor tests positive for MAGE-A4.I am fully active or able to carry out light work.I do not have an active infection with HIV, hepatitis B, hepatitis C, or HTLV.
Research Study Groups:
This trial has the following groups:- Group 1: Afamitresgene autoleucel
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.
Are seniors eligible to participate in this clinical investigation?
"The qualifications for this trial restrict patient age to between 2 and 21 years old."
Answered by AI
Who can partake in the experiment to qualify for participation?
"This trial is limited to 20 participants between the ages of 2 and 21 that have been diagnosed with synovial sarcoma."
Answered by AI
Are there any remaining vacancies for participants in this clinical research?
"Clinicaltrials.gov reveals that this medical trial is not seeking patients at present; it was first posted on May 1st 2023 and the last update occured December 6th 2022. Despite this, there are currently 278 other studies recruiting participants."
Answered by AI
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