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CAR T-cell Therapy

MAGE-A4ᶜ¹º³²T Therapy for Cancer

Phase 1

Waitlist Available

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's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001).

Subject is HLA-A*02 positive. (This determination will be made under screening protocol ADP-0000-001).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years

Awards & highlights

Study Summary

This trial will study the safety of using T cells to attack cancer in patients who express the MAGE-A4 protein in their tumors. A subset of patients will also receive low-dose radiation therapy.

Who is the study for?

This trial is for adults aged 18-75 with certain cancers (like sarcoma, melanoma, and lung cancer) that express the MAGE-A4 protein and are HLA-A*02 positive. They should have measurable disease, adequate organ function, a life expectancy over 6 months, and no active infections like HIV or hepatitis.Check my eligibility

What is being tested?

The study tests MAGE-A4ᶜ¹º³²T cell therapy where patients' T cells are modified to attack tumors expressing MAGE-A4. A subgroup will also receive these T cells plus low-dose radiation to assess safety and effectiveness of this combination.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to modified T cells attacking normal tissue, infusion-related reactions from the treatment administration process, fatigue from energy depletion in body's fight against cancer.

Eligibility Criteria

Inclusion Criteria

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

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My tumor tests positive for MAGE-A4.

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I am HLA-A*02 positive.

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I am between 18 and 75 years old.

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My cancer can be measured by scans before starting treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 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

Determining dose limiting toxicities (DLT) and optimally tolerated dose range

Evaluation of persistence of genetically modified T cells.

T-Lymphocyte

+1 more

Secondary outcome measures

Interval between the date of first T cell infusion and date of death due to any cause.

Interval between the date of first T cell infusion and the earliest date of disease, progression or death due to any cause

Interval between the date of first T cell infusion dose and first documented evidence of CR or PR.

+4 more

Other outcome measures

MAGE-A4c1032T cell trafficking in tumor lesion(s).

Trial Design

2Treatment groups

Experimental Treatment

Group I: Radiation Sub-Study: Autologous genetically modified MAGE-A4c1Experimental Treatment1 Intervention

Group II: Autologous genetically modified MAGE-A4ᶜ¹º³²T cellsExperimental Treatment1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AdaptimmuneLead Sponsor

16 Previous Clinical Trials

10,487 Total Patients Enrolled

David Hong, MDPrincipal InvestigatorM.D. Anderson Cancer Center

6 Previous Clinical Trials

278 Total Patients Enrolled

Media Library

MAGE-A4ᶜ¹º³²T (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03132922 — Phase 1

Head and Neck Cancers Research Study Groups: Radiation Sub-Study: Autologous genetically modified MAGE-A4c1, Autologous genetically modified MAGE-A4ᶜ¹º³²T cells

Head and Neck Cancers Clinical Trial 2023: MAGE-A4ᶜ¹º³²T Highlights & Side Effects. Trial Name: NCT03132922 — Phase 1

MAGE-A4ᶜ¹º³²T (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03132922 — Phase 1

Frequently Asked Questions

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

What key findings are investigators hoping to make through this investigation?

"As reported by the study's primary sponsor, Adaptimmune, their main objective is to measure results over a 3.5 year period. This trial will also be evaluating secondary outcomes such as the proportion of subjects with complete or partial response (according to RECIST v1.1), duration of stable disease and overall survival rate since first T-cell infusion until death from any cause."

Answered by AI

Could you please discuss the safety of Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation for human subjects?

"Taking into consideration the limited evidence base underlying safety and efficacy of autologous genetically modified MAGE-A4c1032T cells used in conjunction with low dose radiation, Power assigned this protocol a score of 1."

Answered by AI

Is it possible to participate in this medical study if one is younger than 25 years old?

"Upon reviewing the inclusion criteria, we find that this trial is accepting individuals from 18 to 75 years old. Further research reveals 247 trials for underage patients and 3120 clinical studies for seniors above 65."

Answered by AI

Is eligibility for this research study open to all applicants?

"This clinical trial is open to 52 participants, aged 18-75 years old, who have been clinically diagnosed with melanoma. Additionally, subjects must be HLA-A*02 positive and express MAGE-A4 RNA or protein. They also need to prove they are in good health through organ function tests outlined by the study protocol as well their tumor meeting RECIST v1.1 criteria before lymphodepletion occurs. Finally, it should be expected that these patients will live longer than 6 months prior to leukapheresis and more than 3 months post lymphodepletion."

Answered by AI

Is the recruitment of participants currently open for this clinical trial?

"Clinicaltrials.gov states that this particular medical trial is currently closed and no longer actively recruiting patients. Initially posted on May 15th 2017, the last amendment was made on August 9th 2022. However, 3220 other clinical studies are presently seeking participants for their respective trials."

Answered by AI

Recent research and studies

OncoImmunologyJournal

Preclinical Evaluation of an Affinity-enhanced Mage-a4-specific T-cell Receptor for Adoptive T-cell Therapy

Sanderson, Joseph P, Darragh J Crowley, Guy E Wiedermann, Laura L Quinn, Katherine L Crossland, Helen M Tunbridge, Terri V Cornforth, et al.. 2019. “Preclinical Evaluation of an Affinity-enhanced Mage-a4-specific T-cell Receptor for Adoptive T-cell Therapy”. Oncoimmunology. Informa UK Limited. doi:10.1080/2162402x.2019.1682381.

clinicaltrials.govStudy

MAGE-A4ᶜ¹º³²T for Multi-Tumor

2017. "MAGE-A4ᶜ¹º³²T for Multi-Tumor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03132922.

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