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CAR T-cell Therapy

ADP-A2M4CD8 T-Cell Therapy for Esophageal Cancer

Phase 2
Waitlist Available
Research Sponsored by Adaptimmune
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1 year post t-cell infusion
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a new cancer treatment, ADP-A2M4CD8 T-cell therapy, is effective against esophageal and EGJ cancer expressing the MAGE-A4 protein.

Who is the study for?
This trial is for adults aged 18-75 with esophageal or esophagogastric junction cancers that express MAGE-A4 and are HLA-A*02 positive. Participants must have had prior treatment, measurable disease, good performance status (ECOG 0 or1), and a heart ejection fraction of at least 50%. Exclusions include uncontrolled illness, pregnancy, certain cardiovascular diseases, previous allergic reactions to study drugs, other active malignancies not in remission, CNS metastases, and active infections.
What is being tested?
The trial tests ADP-A2M4CD8 T-cell therapy in patients with specific genetic markers whose cancer cells express the MAGE-A4 protein. It aims to evaluate the effectiveness of these genetically modified cells in targeting and fighting cancer.
What are the potential side effects?
Potential side effects may include immune system reactions due to cell therapy such as fever or fatigue; possible organ inflammation; infusion-related responses; complications from underlying conditions being exacerbated; and typical risks associated with cellular therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1 year post t-cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 1 year post t-cell infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate (ORR) by Independent Radiological Assessment Committee (IRAC)
Secondary study objectives
Best Overall Response (BOR) by IRAC
Best Overall Response (BOR) by Investigator Assessment
Concordance of the MAGE A-4 Clinical Trial Assay and in Vitro Diagnostic (IVD) Kit.
+13 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: Autologous genetically modified ADP-A2M4CD8 cellsExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

AdaptimmuneLead Sponsor
22 Previous Clinical Trials
10,885 Total Patients Enrolled
ICON plcIndustry Sponsor
85 Previous Clinical Trials
28,473 Total Patients Enrolled

Media Library

ADP-A2M4CD8 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04752358 — Phase 2
Esophageal Cancer Research Study Groups: Autologous genetically modified ADP-A2M4CD8 cells
Esophageal Cancer Clinical Trial 2023: ADP-A2M4CD8 Highlights & Side Effects. Trial Name: NCT04752358 — Phase 2
ADP-A2M4CD8 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752358 — Phase 2
~1 spots leftby Dec 2025
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