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Autologous genetically modified ADP-A2M4CD8 cells for Esophageal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Esophageal Cancer+1 MoreAutologous genetically modified ADP-A2M4CD8 cells - Genetic
Eligibility
18 - 75
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Esophageal Cancer
  • Esophagogastric Junction Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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Autologous genetically modified ADP-A2M4CD8 cells

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 2.5 years

15 years
Overall Survival (OS)
2.5 Years
Efficacy: Best overall response (BOR)
Efficacy: Overall Response Rate (ORR)
2.5 years
Duration of Response (DoR)
Invitro diagnostic (IVD) assay for screening
Number of subjects with treatment -related adverse events (AEs), including serious adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Progression Free Survival (PFS)
Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs
Time to response (TTR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
ABSK021
1
Cohort 1
1
Autologous genetically modified ADP-A2M4CD8 cells

Trial Design

1 Treatment Group

Autologous genetically modified ADP-A2M4CD8 cells
1 of 1

Experimental Treatment

45 Total Participants · 1 Treatment Group

Primary Treatment: Autologous genetically modified ADP-A2M4CD8 cells · No Placebo Group · Phase 2

Autologous genetically modified ADP-A2M4CD8 cells
Genetic
Experimental Group · 1 Intervention: Autologous genetically modified ADP-A2M4CD8 cells · Intervention Types: Genetic

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2.5 years

Who is running the clinical trial?

AdaptimmuneLead Sponsor
15 Previous Clinical Trials
10,424 Total Patients Enrolled
ICON plcIndustry Sponsor
63 Previous Clinical Trials
18,756 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have the HLA-A*02 gene.
You have a tumor that shows MAGE-A4 expression confirmed by central laboratory.
You have a left ventricular ejection fraction (LVEF) of 50% or more.
References

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