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Hepatocellular carcinoma - Healing Genes
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Hepatocellular carcinoma

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Glypican 3-specific Chimeric Antigen Receptor Expressing T Cells for Hepatocellular Carcinoma (GLYCAR)


Phase 1

DESCRIPTION:

Doctors at the Baylor College of Medicine and Houston Methodist Hospital are recruiting participants for an investigation of a new liver cancer treatment combining antibodies and T-cells, the body’s natural defenses. Through gene editing outside the body, the T-cells will be programmed to attack cells found in most hepatocellular carcinomas. Participants must have had hepatocellular carcinoma that returned after standard treatment or did not respond to standard treatment, including patients with metastasis or an inability to receive standard treatment.

Genetic engineering through use of a virus to insert a gene into the patient’s T-cells will prepare the cells to target their cancer. The investigational therapy is not yet FDA approved and researchers seek to find its safest dose, duration in the body, and impact on hepatocellular carcinoma.


PATIENT MUST:

  • Be 18 years of age or older
  • Not have received a liver transplant
  • Not be HIV-positive
  • Not be pregnant or breastfeeding

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Blood will be drawn from the patient and genetically engineered in the lab.
  3. A course of chemotherapy is administered to reduce the patient’s existing bone marrow, giving room for the new cells to grow.
  4. A single infusion of the engineered cells will be given, and the patient’s reaction observed.
  5. After treatment, blood lab tests and follow up will be required 3 to 4 days after the infusion (this time point is optional ) at 1 week, 2 weeks, 4 weeks and 8 weeks after the injection, every 3 months for 1 year, every 6 months for 4 years and then every year for the next 10 years. Total follow up time may last 15 years.

LOCATIONS AND CONTACTS:

The study site is at Houston Methodist Hospital in Houston, TX. Map.

Contacts:

Andras A Heczey, M.D. | [email protected] | 832-824-4233

Jackye Castello | [email protected] | 832-824-4391

SPONSOR INFORMATION:

Baylor College of Medicine Center for Cell and Gene Therapy

The Methodist Hospital System

Or go online:

https://clinicaltrials.gov/ct2/show/NCT02905188

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