Clinical Trial

Disease: Multiple myeloma, MM (NCT05069935)

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 a type of white blood cells known as the plasma cells. 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 Phase I, Open-Label, Multicenter Study of FT538 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
Who:

Study Directors: DeShaun Noakes, Karen Albers

Sponsor:

Fate Therapeutics 

Partners:
Locations:

Not yet disclosed. 

Study start:
Feb. 28, 2022
Enrollment:
189
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
Cluster of differentiation 38 (CD38)
Delivery method:
- Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/NCT05069935
Safety updates:

(20-05-2020) Fate Therapeutics Announces FDA Clearance of IND Application for FT538, First CRISPR-edited, iPSC-derived Cell Therapy

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

Status: Not yet recruiting

Description

This is a Phase 1 dose-finding study of FT538 given in combination with a monoclonal antibody following lymphodepletion in subjects with advanced solid tumours. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts. FT538 is an allogeneic gene-edited natural killer (NK)-cell immunotherapy.

Last updated: Apr. 10, 2022
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