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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
No Placebo-Only Group
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).
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence, duration, and severity of Treatment Emergent Adverse Events as assessed by Investigator Evaluation.
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Afamitresgene autoleucelExperimental Treatment1 Intervention
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Who is running the clinical trial?
AdaptimmuneLead Sponsor
22 Previous Clinical Trials
10,868 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
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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.
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