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CAR T-cell Therapy

ADP-A2M4CD8 + Immunotherapy for Advanced Cancers

Phase 1

Recruiting

Led By David Hong, MD

Research Sponsored by Adaptimmune

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is positive for at least 1 HLA-A*02 inclusion allele

ECOG Performance Status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2.5 years

Awards & highlights

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.

Who is the study for?

This trial is for adults aged 18-75 with certain cancers (like esophageal, stomach, lung, bladder, melanoma) that are HLA-A2+ and MAGE-A4+. They should have a good performance status and normal heart function. Excluded are those with uncontrolled illnesses, pregnant or breastfeeding women, history of severe allergies to study drugs, active autoimmune diseases, brain metastases or another cancer not in remission.Check my eligibility

What is being tested?

The trial tests ADP-A2M4CD8 T-cell therapy alone or combined with nivolumab every four weeks or pembrolizumab every six weeks. It aims to assess the safety and effectiveness of these treatments in patients whose tumors express a specific protein (MAGE-A4) and have a particular human leukocyte antigen (HLA).See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in different body parts. There may also be risks associated with infusion reactions from the T-cell therapy or the checkpoint inhibitors nivolumab/pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least one HLA-A*02 gene variant.

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I am fully active or can carry out light work.

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My tumor tests positive for MAGE-A4.

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My cancer can be measured by scans before specific treatments.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab

To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab

Secondary outcome measures

Anti-tumor activity: Best overall response (BOR)

Anti-tumour activity: Overall Response Rate (ORR)

Duration of Response (DOR)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Autologous genetically modified ADP-A2M4CD8 cellsExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

ICON plcIndustry Sponsor

80 Previous Clinical Trials

25,026 Total Patients Enrolled

AdaptimmuneLead Sponsor

16 Previous Clinical Trials

10,438 Total Patients Enrolled

David Hong, MDPrincipal InvestigatorM.D. Anderson Cancer Center

6 Previous Clinical Trials

229 Total Patients Enrolled

Media Library

ADP-A2M4CD8 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04044859 — Phase 1

Head and Neck Cancers Research Study Groups: Autologous genetically modified ADP-A2M4CD8 cells

Head and Neck Cancers Clinical Trial 2023: ADP-A2M4CD8 Highlights & Side Effects. Trial Name: NCT04044859 — Phase 1

ADP-A2M4CD8 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04044859 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor include persons aged eighty or above?

"Patients aged 18 to 75 are eligible for enrollment in this medical research."

Answered by AI

What criteria must be fulfilled to qualify for this medical experiment?

"This clinical trial is seeking 90 adults, between 18 and 75 years old, with a melanoma diagnosis. Furthermore, to be eligible for the trial they must meet additional criteria such as having at least one HLA-A*02 inclusion allele present in their system, measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletion., MAGE-A4 expression confirmed by central laboratory testing, LVEF ≥50% or institutional lower limit of normal range (whichever is lower), and ECOG Performance Status of 0 or 1."

Answered by AI

How many venues are carrying out the research project?

"The 12 sites participating in the trial are comprised of The University of Oklahoma Health Sciences Center (Oklahoma City), Massachusetts General Hospital (Boston) and OU Health Stephenson Cancer Centre (Houston). Additionally, there are 9 other medical centres running this study."

Answered by AI

Are there vacancies in this clinical trial for participation?

"According to the information posted on clinicaltrials.gov, this medical trial is still open for recruitment. The study was first uploaded in August 20th 2019 and its details were most recently updated three years later."

Answered by AI

Is there any risk associated with Autologous genetically modified ADP-A2M4CD8 cell treatment?

"Our team assessed the safety of Autologous genetically modified ADP-A2M4CD8 cells to be a 1 due to it being in Phase 1. Thus, there is limited evidence for its efficacy and safety."

Answered by AI

What is the aggregate tally of participants in this clinical experiment?

"A total of 90 eligible participants are needed to commence this clinical trial. Recruited patients can be found at the University of Oklahoma Health Sciences Center (Oklahoma City, OK) and Massachusetts General Hospital (Boston, MA)."

Answered by AI

What aims is this clinical trial attempting to achieve?

"This trial seeks to evaluate the number of patients experiencing treatment-related adverse events, including serious adverse reactions, over two and a half years. The secondary goals include assessing duration of stable disease, anti-tumour activity via overall response rate, and time taken to achieve a partial or complete response."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)

2019. "ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04044859.

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