Autologous genetically modified ADP-A2M4CD8 cells for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Melanoma+18 More
Autologous genetically modified ADP-A2M4CD8 cells - Genetic
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study ADP-A2M4CD8 T-cell therapy, given to people with certain HLA types and tumors that express the MAGE-A4 antigen. Tumor types include endometrial, esophageal, EGJ, gastric, head and neck, melanoma, NSCLC, ovarian, and urothelial cancer.

Eligible Conditions
  • Melanoma
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Malignant Neoplasm of Stomach
  • Transitional Cell, Carcinoma
  • Esophagogastric Junction Disorder
  • Head and Neck
  • Ovarian Cancer
  • Urothelial Cancer
  • Esophagogastric Junction
  • Endometrial Cancer
  • Esophageal Neoplasms Malignant
  • Malignant Neoplasms
  • Head and Neck Cancer
  • Non-small Cell Lung (NSCLC)

Treatment Effectiveness

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: 2.5 years

15 years
Evaluate safety of ADP-A2M4CD8 through measurement of Replication -competent Retrovirus in genetically engineered T-cells
Overall Survival (OS)
2.5 years
Anti-tumor activity: Best overall response (BOR)
Anti-tumour activity: Overall Response Rate (ORR)
Duration of Response (DOR)
Duration of stable disease (DoSD)
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 to response (TTR)
Nivolumab
Up to 15 years
To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with nivolumab

Trial Safety

Trial Design

1 Treatment Group

Autologous genetically modified ADP-A2M4CD8 cells
1 of 1

Experimental Treatment

90 Total Participants · 1 Treatment Group

Primary Treatment: Autologous genetically modified ADP-A2M4CD8 cells · No Placebo Group · Phase 1

Autologous genetically modified ADP-A2M4CD8 cellsExperimental Group · 2 Interventions: Autologous genetically modified ADP-A2M4CD8 cells, Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks · Intervention Types: Genetic, Genetic

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

AdaptimmuneLead Sponsor
14 Previous Clinical Trials
10,359 Total Patients Enrolled
3 Trials studying Melanoma
66 Patients Enrolled for Melanoma
ICON plcIndustry Sponsor
62 Previous Clinical Trials
18,633 Total Patients Enrolled
3 Trials studying Melanoma
464 Patients Enrolled for Melanoma
David Hong, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
160 Total Patients Enrolled
3 Trials studying Melanoma
131 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically or cytogenetically confirmed diagnosis of urothelial cancer, esophageal, EGJ cancer, gastric cancer, NSCLC, head and neck or ovarian cancer, endometrial cancer, melanoma.
You have measurable disease according to RECIST v1.
You have a tumor that shows MAGE-A4 expression as confirmed by central laboratory.
You have a left ventricular ejection fraction (LVEF) of 50% or less.
You have no signs or symptoms of cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: November 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.