Clinical Trial

Disease: Relapsed or Refractory 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 characterised by abnormalities in plasma cells, a type of white blood cell. In myeloma, these abnormal cells multiply uncontrollably, 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.

Relapsed myeloma refers to when a patient had active treatment that their disease responded to, went off treatment and then the disease came back. 

Refractory myeloma is a disease that is progressing despite active treatment.

 

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:

Contact

Allogene Therapeutics

Phone: 415-650-0034

Email: clinicaltrials@allogene.com

Sponsor:

Allogene Therapeutics, Inc.

Partners:
Locations:

United States, Colorado

Sarah Cannon/Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

 

United States, Texas

St. David's South Austin Medical Center, Austin, Texas, United States, 78704

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Texas Transplant InstituteRecruitingSan Antonio, Texas, United States, 78229

Study start:
Jun. 6, 2021
Enrollment:
136 participants
Gene editing method:
TALENs
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:

(30-05-2023) ALLO-605 by Allogene Therapeutics for Relapsed Multiple Myeloma: Likelihood of Approval

(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: Apr. 20, 2024
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