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B-cell Non-Hodgkin Lymphoma with BCL2 Gene Rearrangement - Healing Genes
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B-cell Non-Hodgkin Lymphoma with BCL2 Gene Rearrangement

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JCAR014 and Durvalumab in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

A Phase 1b Study of JCAR014, Autologous T Cells Engineered to Express a CD19-Specific Chimeric Antigen Receptor, in Combination With Durvalumab (MEDI4736) for Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma


Phase 1

DESCRIPTION:

Doctors at the Fred Hutchinson University of Washington Cancer Consortium seek patients to trial a treatment of B-cell non-Hodgkin lymphomas. This treatment uses the patient’s own immune T-cells to gene-modify them in the laboratory, programming them with a gene to help them kill lymphoma cells. It will be delivered back to the patients along with an antibody medicine that may help immune cells attack cancer cells.

The trial will require leukapheresis to collect the immune cells from the bloodstream, then after they are gene-modified, chemotherapy will prepare the immune system for the self-transplant. The modified T-cells are re-infused, followed by the antibody therapy, and follow up will continue for up to 15 years and include lab, physical, and imaging assessments.


PATIENT MUST:

  • Be 18 years of age or older
  • Have a diagnosis meeting specific clinical criteria that includes:
    • Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; primary mediastinal B-cell lymphoma (PMBCL); or DLBCL transformed from indolent histology
      • Relapsed after or refractory to prior treatment with at least two regimens or lines of treatment
      • Prior failure of at least one regimen or line of treatment or after autologous stem cell transplant

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Leukapheresis collection of T-cells and no treatment while they are modified in the lab.
  3. The modified T-cells are re-infused after a round of chemotherapy.
  4. Antibody treatment (Durvalumab) given by IV.
  5. Recovery period and follow up for 12 months requiring regular lab assessments.
  6. Patients are followed for up to 15 years.

LOCATIONS & CONTACTS:
Trials will take place at the Fred Hutchinson/University of Washington Cancer Consortium in Seattle, WA. Map.

Contact:
Immunotherapy Trials Intake, SCCA  |  206-606-4668  |  [email protected]
 
SPONSORS
Fred Hutchinson Cancer Research Center
AstraZeneca
Juno Therapeutics, Inc.
MedImmune LLC
National Cancer Institute (NCI)
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02706405

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