Disease: B Cell Malignancies, B Cell Leukemia, B Cell Lymphoma, NHL, (NCT03398967)

Disease info:

B-cell lymphoma refers to types of non-Hodgkin lymphoma that are characterised by abnormalities of the "B-cells" (a type of white blood cell that makes antibodies to help fight infection). The condition may grow and spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms.

Frequency:
In 2016, there were an estimated 694,704 people living with non-Hodgkin lymphoma in the United States.
Official title:
Phase I/II Study to Evaluate Treatment of Relapsed or Refractory Leukemia and Lymphoma With Universal CRISPR-Cas9 Gene-Editing CAR-T Cells Targeting CD19 and CD20 or CD22
Who:

Principal Investigator: Weidong Han, Dr.       

Principal Investigator: Daihong Liu, Dr. 

Partners:
Locations:

China, Beijing

Study start:
Jan. 2, 2018
Enrollment:
80 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out and gene knock-in
Gene:
anti-CD19/CD20 CAR or anti-CD19/CD22 CAR
Delivery method:
Viral - Ex-vivo
IndicatorIndicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies. However, a subset of patients relapse due to the loss of CD19 in tumour cells. Dual specificity CD19 and CD20 or CD22 CAR-T cells can recognise and kill the CD19 negative malignant cells through recognition of CD20 or CD22. This is a phase 1/2 study designed to determine the safety of the allogenic gene-edited dual specificity CD19 and CD20 or CD22 CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory hematological malignancies.

The primary objectives of this trial are :

  • To evaluate the feasibility and safety of universal dual specificity CD19 and CD20 or CD22 CAR-T cells in patients with relapsed or refractory leukaemia and lymphoma.
  • To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells. Real Time polymerase chain receptor (RT-PCR) and Flow cytometry (FCM) analysis of PB, BM and lymph node will be used to detect and quantify survival of universal dual specificity CD19 and CD20 or CD22 CAR-T cells over time.

The secondary objectives of the trial are:

  • For patients with detectable disease, measure anti-tumour response due to universal dual specificity CD19 and CD20 or CD22 CAR-T cell infusions.
  • Determine if cellular or humoral host immunity develops against the murine anti-CD19, and assess correlation with loss of detectable universal dual specificity CD19 and CD20 or CD22 CAR-T cells (loss of engraftment).

The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using a "split dose" approach to dosing: 10% on day 0, 30% on day 1 and 60% on day 2.

Last updated: Apr. 5, 2021
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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