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B-Cell Malignancies - Healing Genes
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B-Cell Malignancies

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CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR)

Allogeneic Natural Killer T-Cells Expressing CD19 Specific Chimeric Antigen Receptor and Interleukin-15 in Relapsed or Refractory B-Cell Malignancies


Phase 1

DESCRIPTION:

Researchers at Houston Methodist Hospital and Texas Children’s Hospital seek patients with B-cell lymphoma or leukemia that tests positive for CD19 antigens to trial an investigatory treatment that gene-modifies their own immune natural killer T cells (NKT) to add 3 genes:

  • A gene to produce molecules on their surface that recognize lymphoma
  • A gene to make the NKT cells live longer
  • A gene to produce Interleukin 15 (IL-15) which stimulates immune response to tumors

After leukapheresis to collect the T-cells, they are gene-modified in the lab, then returned to the patient following chemotherapy. On the day patients receive the cells, blood will be taken before the cells are given and a few hours afterwards. Other blood will be drawn one week after the infusion, 2 weeks, 3 weeks (optional), 4 weeks, and 6 weeks after the infusion, at 3 months, at 6 months, at 9 months, at 1 year, twice a year for 4 years, then yearly for the next 10 years – for a total of 15 years.


PATIENT MUST:

  • Be 18 to 75 years of age
  • Have relapsed or refractory CD19-positive B-cell lymphoma or leukemia (ALL or CLL)
  • Life expectancy of at least 12 weeks
  • Be willing to use birth control during the study

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Leukapheresis to isolate T-cells which are then modified in the lab.
  3. Admission to the hospital with chemotherapy to prepare the immune system.
  4. The gene-modified T cells will be administered through an IV line following a day of rest.
  5. On the day patients receive the cells, blood will be taken before the cells are given and a few hours afterwards. Other blood will be drawn one week after the infusion, 2 weeks, 3 weeks (optional), 4 weeks, and 6 weeks after the infusion, at 3 months, at 6 months, at 9 months, at 1 year, twice a year for 4 years, then yearly for the next 10 years – for a total of 15 years.

LOCATIONS & CONTACTS:
The study sites are at Houston Methodist Hospital (Map) and at Texas Children’s Hospital in Houston, TX (Map).

Contacts:
Carlos Ramos, MD  |  (832) 824-4817  |  [email protected]
 
SPONSORS
Baylor College of Medicine
Center for Cell and Gene Therapy, Baylor College of Medicine
Texas Children’s Hospital
The Methodist Hospital System
 
Or go online:
https://clinicaltrials.gov/show/NCT03774654

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