Clinical Trial

Disease: Multiple myeloma, MM (NCT05000450)

Disease info:

Multiple myeloma is a cancer that develops in the bone marrow, the spongy tissue found in the centre of most bones. Multiple myeloma is characterized by abnormalities in plasma cells, a type of white blood cell. These abnormal cells multiply out of control, increasing from about one percent of cells in the bone marrow to the majority of bone marrow cells. The abnormal cells form tumours within the bone, causing bone pain and an increased risk of fractures.

Frequency:
Multiple myeloma occurs in approximately 4 per 100,000 people per year; there are currently about 100,000 affected individuals in the United States.
Official title:
A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Who:

Allogene Therapeutics, 415-650-0034, clinicaltrials@allogene.com

Sponsor:

Allogene Therapeutics, Inc.

Partners:

No

Locations:

United States, Colorado

United States, Texas

Study start:
Jun. 6, 2021
Enrollment:
136
Gene editing method:
TALEN
Type of edit:
Gene knock-out, gene knock-in
Gene:
CD52 molecule, T-Cell Receptor Alpha Constant (TRAC), B-Cell Maturation Antigen (anti-BCMA CAR)
Delivery method:
Lentivirus (LV), electroporation - Ex-vivo
Trial link:
https://www.allogene.com/pipeline
Safety updates:

(27-04-2022) Allogene Therapeutics Receives FDA Orphan-Drug Designation for ALLO-605, its First TurboCAR™ T Cell Product Candidate, for the Treatment of Multiple Myeloma

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

(30-06-2021) Allogene Therapeutics Granted FDA Fast Track Designation for ALLO-605, the First TurboCAR™ T Cell Therapy, for the Treatment of Relapsed/Refractory Multiple Myeloma

(19-04-2021) Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-605, the First TurboCAR™ Candidate, for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma

(07-12-2020) Allogene Therapeutics Presents Preclinical Findings Supporting ALLO-605, the First Anti-BCMA TurboCAR™ T Cell Therapy, at the 62nd Meeting of the American Society of Hematology

Other links:

LinkMultiple Myeloma Disease Information and FrequencyLinkPreclinical Evaluation of ALLO-605, an Allogeneic BCMA Turbocar TTM Cell Therapy for the Treatment of Multiple MyelomaLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem QasimLinkGene-Editing IND and Pre-clinical Update

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

Status: Active recruiting

Description

Allogene developed the TurboCAR technology to further enhance the potency of cell therapies. This technology allows ligand independent, cytokine signaling to be engineered selectively into CAR T cells. TurboCARs have the potential to enhance AlloCAR T cell proliferation and overcome T cell exhaustion

ALLO-605: B-Cell Maturation Antigen (BCMA) CAR T cells were generated from healthy donor T cells by lentiviral transduction with a CAR construct followed by genetic inactivation of the T-Cell Receptor Alpha Constant (TRAC) and CD52 loci using TALEN gene editing. Allogeneic BCMA TurboCAR T cells, engineered for stoichiometric expression of the CAR and a Constitutively Active Chimeric Cytokine Receptor (CACCR) via a self-cleaving peptide, were produced similarly.

Last updated: May. 11, 2022
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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