Clinical Trial

Disease: Relapsed or Refractory Non-Hodgkin Lymphoma, NHL, (NCT03939026)

Disease info:

Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. NHL is a term that's used for many different types of lymphoma that all share some of the same characteristics. NHL usually starts in lymph nodes or other lymph tissue, but it can sometimes affect the skin. 

Non-Hodgkin lymphoma is one of the most common cancers in the United States, accounting for about 4% of all cancers. 

Relapsed refers to when a patient has received active treatment, went off treatment and then the disease came back, whereas refractory refers to disease that is progressing despite active treatment.

Frequency:
NHL accounts for about 4% of all cancers in the U.S. The American Cancer Society estimates 80,550 people will be diagnosed with NHL in 2023.
Official title:
A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma
Who:
Sponsor:

Allogene Therapeutics

Partners:
Locations:

United States, Arizona

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

 

United States, California

University of California, Los Angeles, Los Angeles, California, United States, 90095

Stanford University, Stanford, California, United States, 94305

 

United States, Colorado

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

 

United States, Florida

Moffitt Cancer Center, Tampa, Florida, United States, 33612

 

United States, Kentucky

Norton Cancer Institute, Louisville, Kentucky, United States, 40207

 

United States, Texas

St. Davids South Austin Medical Center, Austin, Texas, United States, 78704

MD Anderson, Houston, Texas, United States, 77030

Study start:
May. 1, 2019
Enrollment:
74 participants
Gene editing method:
TALENs
Type of edit:
Gene knock-out
Gene:
T Cell Receptor alpha locus (TCRα), CD52 molecule
Delivery method:
Electroporation and Lentivirus (LV) - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT03939026
Safety updates:

(15-06-2023) Allogene Therapeutics Provides Additional ALLO-501/501A Phase 1 Data in an Oral Presentation at the International Conference on Malignant Lymphoma (ICML) Lugano

(03-06-2023) Allogene Therapeutics Presents Updated ALLO-501/501A Phase 1 Data in Large B Cell Lymphoma at the American Society of Clinical Oncology (ASCO) Annual Meeting

(13-12-2021) Allogene Therapeutics Reports Positive Phase 1 Data from the ALPHA Trials in Non-Hodgkin’s Lymphoma at the 63rd Annual Meeting of the American Society of Hematology

(07-10-2021) Allogene Therapeutics Reports FDA Clinical Hold of AlloCAR T Trials Based on a Single Patient Case in ALPHA2 Trial

(29-05-2020) Allogene Therapeutics, with Collaborator Servier, Reports Positive Results from its Phase 1 ALPHA Study of ALLO-501 in Relapsed/Refractory Non-Hodgkin Lymphoma at the American Society of Clinical Oncology Annual Meeting

Other links:

LinkNon-Hodgkin's Lymphoma- B cell malignancies InformationLinkNon-Hodgkin’s Lymphoma FrequencyLinkAllogene: AlloCAR T TherapyLinkAllogene: Scientific publicationsLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem Qasim

Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active not recruiting

Description

The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

ALLO-501 is an investigational off-the-shelf CAR-T therapy using T-cells harvested from healthy donors.

These cells are isolated in a manufacturing facility, engineered to express synthetic T cell receptors, CARs (chimeric antigen receptors) to recognize and destroy cancer cells, and modified via gene editing to limit autoimmune response when given to a patient.

The harvested T-cells are edited using TALENs (Cellectis' technology) to knockout two genes.

T cell receptor gene is knocked out to minimize risk of GvHD​ (Graft versus Host Disease).

The CD52 gene is knocked out to render the CAR T product resistant to anti-CD52 antibody treatment. ALLO-647, anti-CD52 monoclonal antibody, is designed to suppress the host immune system and allow the AlloCAR-T TM therapy to stay engrafted in order to achieve full therapeutic impact.

ALLO-501 recognize CD19, a cell-surface protein expressed on B-cells, including cancerous B-cells.

Last updated: Dec. 28, 2023
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