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Acute Lymphoid Leukemia - Healing Genes
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Acute Lymphoid Leukemia

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Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL

Phase 2 Study of Humanized CD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19) for Very High-Risk Subsets of B Cell Acute Lymphoblastic Leukemia (B-ALL)


Phase 1

DESCRIPTION:

Doctors at the Children’s Hospital of Philadelphia seek to enroll patients in a clinical trial to treat newly diagnosed B-ALL patients predicted to have an exceedingly poor outcome with conventional chemotherapy, in high-risk first relapse, or and in second or greater relapse that tests positive for CD19+ antigens.

The investigatory treatment, a gene-modified immunotherapy, withdraws immune T-cells from the patient and, utilizing gene editing, the white blood cells will be trained to target their cancer cells. Then the modified T-cells will be infused to the patient after a course of chemotherapy. Follow up lasts at least 1 year.


PATIENT MUST:

  • Be 1 to 29 years of age
  • Be diagnosed with one of the eligible cancers, with DNA tests to confirm subtype required
  • Be HIV negative

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Have blood drawn, immune cells separated and blood cells returned (leukapheresis)
  3. After lab modification time, the patient will be admitted to the hospital and receive chemotherapy over 3 to 5 days.
  4. The gene-edited immune cells will be infused.
  5. Recovery in the hospital.
  6. Follow up continues for at least 1 year.

LOCATIONS AND CONTACTS:
The study site is at the Children’s Hospital of Pennsylvania in Philadelphia, PA. Map.

Contact:
Mia Benson-Smith  |  267-426-0762  |  [email protected]
Claire White  |  [email protected]
 
SPONSOR INFORMATION:
University of Pennsylvania
The Children’s Hospital of Philadelphia
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT03792633

 

 

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