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Metastatic Cancer Expressing The Mage-a3 Molecule - Healing Genes
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Metastatic Cancer Expressing The Mage-a3 Molecule

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T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive

Phase I/II Study of the Treatment of Metastatic Cancer That Expresses MAGE-A3 Using Lymphodepleting Conditioning Followed by Infusion of HLA-DP0401/0402 Restricted Anti-MAGE-A3 TCR-Gene Engineered Lymphocytes and Aldesleukin


Phase 1

DESCRIPTION:
A trial for an investigatory gene therapy to treat metastatic cancers that produce the MAGE-A3 molecule is recruiting patients at the National Institutes of Health Clinical Center. Patients with such cancers may be eligible for this therapy that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these cells with a type of virus that imparts a gene to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer.

The treatment requires leukapheresis to obtain the immune cells which are then gene-modified to add the anti-MAGE-A3 abilities, then after chemotherapy in the hospital, the modified cells are re-infused to the patient. After 4 weeks recovery, follow up will continue for every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking.


PATIENT MUST:

  • Be 18 Years to 70 years of age
  • Have metastatic or locally advanced refractory/recurrent cancer that expresses MAGE-A3, confirmed clinically with NIH lab
  • Have previously received prior first line standard therapy

THE STUDY INVOLVES:

  1. Screening before the treatment (including lab tests, MRIs, physical assessments, and nerve biopsies).
  2. Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed
  3. Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-MAGE-A3-DP0401/0402 cells. {Leukapheresis is a procedure which removes only the white blood cells from the patient.}
  4. Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-MAGE-A3-DP0401/0402 cells and aldesleukin. They will stay in the hospital for approximately 4 weeks for the treatment.
  5. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking.

LOCATIONS AND CONTACTS:
Trials will take place at the National Institutes of Health Clinical Center in Bethesda, MD. Map.
Contact:
Margaret Shovlin, R.N.  |  (866) 820-4505  |  [email protected]
 
SPONSOR INFORMATION:
National Cancer Institute (NCI)
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02111850

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