MAGE-A4ᶜ¹º³²T Therapy for Cancer

Recruiting in Palo Alto (17 mi)

+10 other locations

David S Hong | MD Anderson Cancer Center

Overseen byDavid Hong, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Adaptimmune

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid/round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors. This study has a substudy component that will investigate the safety and tolerability of MAGE-A4c1032T cell therapy in combination with low dose radiation in up to 10 subjects.

Research Team

David Hong, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

You are expected to live for at least 6 months before a certain procedure and 3 months before another procedure.

My tumor tests positive for MAGE-A4.

I am HLA-A*02 positive.

See 5 more

Exclusion Criteria

Subject is pregnant or breastfeeding.

I have no other active cancers and no uncontrolled illnesses.

I have symptoms from cancer spreading to my brain.

See 7 more

Treatment Details

Interventions

Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation (CAR T-cell Therapy)
MAGE-A4ᶜ¹º³²T (CAR T-cell Therapy)

Trial OverviewThe 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.

Participant Groups

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