Clinical Trial

Disease: Relapsed or Refractory Multiple Myeloma, MM, (NCT05182073)

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 Phase I Study of FT576 as Monotherapy and in Combination With Daratumumab in Subjects With Relapsed/Refractory Multiple Myeloma
Who:

Contact

Who: Fate Trial Disclosure

Phone: 866-875-1800

Email: FateTrialDisclosure@fatetherapeutics.com

Sponsor:

Fate Therapeutics Inc.

Partners:
Locations:

United States, Alabama

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35249

United States, California

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

United States, Colorado

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

United States, Delaware

Medical Oncology Hematology Consultants, PA, Newark, Delaware, United States, 19713

United States, Indiana

Indiana University Melvin and Bern Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States, 46202

United States, Ohio

Oncology Hematology Care, Inc:, Cincinnati, Ohio, United States, 45242

United States, Tennessee

Tennessee Oncology - Nashville, Nashville, Tennessee, United States, 37203

United States, Texas

Texas Oncology-Medical City Dallas, Dallas, Texas, United States, 75230

United States, Virginia

Virginia Oncology Associates, Norfolk, Virginia, United States, 23502

United States, Wisconsin

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

Study start:
Nov. 24, 2021
Enrollment:
168 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out, gene knock-in
Gene:
B-cell Maturation Antigen (BCMA) CD38
Delivery method:
- Ex-vivo
Trial link:
https://fatetherapeutics.com/pipeline/immuno-oncology-candidates/ft576/
Safety updates:

(10-12-2022) Fate Therapeutics Highlights iPSC-derived, Off-the-shelf CAR NK Cell Programs for Multiple Myeloma at 2022 ASH Annual Meeting

(06-12-2020) Fate Therapeutics Presents Patient Case Study Demonstrating Clinical Activity of FT596 in Refractory Diffuse Large B-cell Lymphoma Screen reader support enabled.

 

 

 

 

Other links:

LinkMultiple Myeloma Disease Information and FrequencyLinkFT576: A Novel Multiplexed Engineered Off-the-Shelf Natural Killer Cell Immunotherapy for the Dual-Targeting of CD38 and Bcma for the Treatment of Multiple MyelomaLinkExplainer: The Clinical Development Path

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

Status: Active recruiting

Description

This is a Phase I dose-finding study of FT576 as monotherapy and in combination with the monoclonal antibody daratumumab in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage.

FT576 incorporates four functional modifications: a proprietary CAR that targets BCMA; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to augment ADCC; an IL-15 receptor fusion (IL-15RF) that promotes enhanced NK cell activity; and the elimination of CD38 expression to mitigate the potential for NK cell fratricide. Together, these features are intended to enable multi-antigen targeting of myeloma cells, augment ADCC, enhance cell persistence and prevent anti-CD38 monoclonal antibody-induced fratricide.

Last updated: Dec. 28, 2023
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