Clinical Trial

Disease: Relapsed or Refractory Multiple Myeloma, MM, (NCT04093596)

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 Study of the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy With or Without Nirogacestat in Subjects With Relapsed/Refractory Multiple Myeloma
Who:

Contact

Allogene Therapeutics

Phone: 415-604-5696

Email: clinicaltrials@allogene.com

Sponsor:

Allogene Therapeutics

Partners:
Locations:

United States, Arizona

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

 

United States, California

City of Hope, Duarte, California, United States, 91010

Stanford Cancer Institute, Palo Alto, California, United States, 94305

 

United States, Colorado

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

 

United States, Massachusetts

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States, 02144

 

United States, Minnesota

Mayo Clinic, Rochester, Minnesota, United States, 55905

 

United States, New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

 

United States, Ohio

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States, 44195

 

United States, Tennessee

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States, 37203

 

United States, Texas

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

Texas Transplant Institute, San Antonio, Texas, United States, 78229

 

United States, Wisconsin

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Study start:
Sep. 23, 2019
Enrollment:
132 participants
Gene editing method:
TALENs
Type of edit:
Gene disruption
Gene:
T-cell receptor alpha constant (TRAC) and the CD52
Delivery method:
Electroporation and Lentivirus (LV) - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT04093596
Safety updates:

(15-11-2022) Universal Updated Phase 1 Data Highlights Role of Allogeneic Anti-BCMA ALLO-715 Therapy for Relapsed/Refractory Multiple Myeloma

(13-12-2021) Allogene Therapeutics Reports Positive Results from Phase 1 UNIVERSAL Study of Single Dose ALLO-715 AlloCAR T™ Cell Therapy in Relapsed/Refractory Multiple Myeloma at the 63rd American Society of Hematology Annual Meeting

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

(12-08-2021) Allogene Therapeutics Receives FDA Orphan Drug Designation (ODD) for ALLO-715 for the Treatment of Multiple Myeloma (MM)

(21-04-2021) Allogene Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to ALLO-715, an AlloCAR T™ Cell Therapy in Development for Relapsed/Refractory Multiple Myeloma. 

(05-12-2020) Allogene Therapeutics Reports Positive Initial Results from Phase 1 UNIVERSAL Study of ALLO-715 AlloCAR T™ Cell Therapy in Relapsed/Refractory Multiple Myeloma at the 62nd American Society of Hematology Annual Meeting

Other links:

LinkMultiple Myeloma Disease Information and FrequencyLinkAllogene: Scientific publicationsLinkPreclinical Evaluation of Allogeneic CAR T Cells Targeting BCMA for the Treatment of Multiple Myeloma.LinkThe 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 recruiting

Description

The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone.

  • Genetic: ALLO-715

    ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA

  • Biological: ALLO-647

    ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

ALLO-715 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-715 recognize BCMA, a cell-surface protein universally expressed on malignant plasma cells.

The safety profile of allogeneic BCMA CAR Ts was further enhanced by incorporating a CD20 mimotope-based intra-CAR off-switch allowing investigators to destroy genetically-modified T-cells in the presence of Rituxan (rituximab), if needed.

Last updated: Dec. 28, 2023
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