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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 weeks
Treatment ~ Varies
Follow Up ~3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

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 more

Awards & 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

Find a Location

Who is running the clinical trial?

AdaptimmuneLead Sponsor
20 Previous Clinical Trials
10,856 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

Afamitresgene autoleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05642455 — Phase 1 & 2
Osteosarcoma Research Study Groups: Afamitresgene autoleucel
Osteosarcoma Clinical Trial 2023: Afamitresgene autoleucel Highlights & Side Effects. Trial Name: NCT05642455 — Phase 1 & 2
Afamitresgene autoleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05642455 — Phase 1 & 2
~12 spots leftby Oct 2026
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