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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 2.5 years
Awards & highlights

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.

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.Check my eligibility
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.See study design
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 ~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
Efficacy: Overall Response Rate (ORR)
Secondary outcome measures
Duration of Response (DoR)
Efficacy: Best overall response (BOR)
Invitro diagnostic (IVD) assay for screening
+5 more

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
16 Previous Clinical Trials
10,513 Total Patients Enrolled
ICON plcIndustry Sponsor
80 Previous Clinical Trials
25,101 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

Frequently Asked Questions

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

Are there any safety risks associated with Autologous genetically modified ADP-A2M4CD8 cells use?

"Our team at Power has rated Autologous genetically modified ADP-A2M4CD8 cells as a 2 on the safety scale, since there is evidence of its security but no proof that it can be effective."

Answered by AI

Does this research project allow participants aged sixty or older to take part?

"The parameters state that only individuals aged between 18 and 75 are eligible to be part of this trial. There is a separate set of 10 trials available for those below the age of majority, as well as 378 distinct studies tailored towards seniors over 65 years old."

Answered by AI

Is there presently an opportunity for individuals to join this research project?

"The information on clinicaltrials.gov reveals that this trial is still actively seeking participants and has been since September 15th 2021. It was most recently updated on August 23rd 2022."

Answered by AI

Is it possible for me to join this research project?

"This clinical trial is recruiting 45 persons with esophageal cancer under the age of 75 and over 18. Eligibility for this study includes HLA-A*02 positivity, MAGE-A4 expression as determined by a central laboratory, RECIST v1.1 measurable disease criteria, ECOG Performance Status 0 or 1, and LVEF ≥50%. Other protocol specific qualifications may also be applicable."

Answered by AI

What is the size of the sample group for this research?

"To adequately assess the efficacy of this medical intervention, 45 suitable candidates are required for enrolment. These patients will be accepted from Froedtert Hospital and Medical College of Wisconsin in Milwaukee, Wisconsin or Providence Cancer Institute Franz Clinic in Portland, Oregon."

Answered by AI

Can you enumerate the amount of locations participating in this research within the city?

"The present clinical trial is being administered in 25 different hospitals, including Milwaukee, Portland and Toronto. Participants should select the site closest to them for minimal travel requirements."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
2021. "ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04752358.
~13 spots leftby Apr 2025
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