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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).
Must not have
Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness.
Subject has symptomatic CNS metastases.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have no other active cancers and no uncontrolled illnesses.
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I have symptoms from cancer spreading to my brain.
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I have an active infection with HIV, HBV, HCV, or HTLV.
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My cancer has spread to my spine and may be affecting my spinal cord.
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My genotype does not match the required HLA-A type.
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I do not have a tumor that can be treated with radiation.
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I have not had radiation therapy in the last 6 months.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determining dose limiting toxicities (DLT) and optimally tolerated dose range
Evaluation of persistence of genetically modified T cells.
T-Lymphocyte
+1 more
Secondary study objectives
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 study objectives
MAGE-A4c1032T cell trafficking in tumor lesion(s).

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

AdaptimmuneLead Sponsor
20 Previous Clinical Trials
10,805 Total Patients Enrolled
4 Trials studying Melanoma
144 Patients Enrolled for Melanoma
David Hong, MDPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
2,926 Total Patients Enrolled
3 Trials studying Melanoma
199 Patients Enrolled for Melanoma

Media Library

MAGE-A4ᶜ¹º³²T (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03132922 — Phase 1
Melanoma Research Study Groups: Radiation Sub-Study: Autologous genetically modified MAGE-A4c1, Autologous genetically modified MAGE-A4ᶜ¹º³²T cells
Melanoma 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
~8 spots leftby Nov 2025
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