Disease: Allogeneic CAR-T for multiple myeloma

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 cell 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:
Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-BCMA-ALLO1 in Subjects With Relapsed / Refractory Multiple Myeloma (MM)
Who:

Study Director:Matthew Spear, M.D.Sponsor Chief Medical Officer

Sponsor:

Poseida Therapeutics, Inc.

Partners:

None

Locations:

None yet disclosed. 

Study start:
Oct. 1, 2021
Enrollment:
40
Gene editing method:
Cas-CLOVER
Type of edit:
Gene knock-out
Gene:
T cell receptor
Delivery method:
Electroporation - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting

Description

Phase 1 study follows a 3+3 design of dose-escalating cohorts. After a subject enrolls, allogeneic CAR-T cells will be administered as a single dose, following a standard chemotherapy based conditioning regimen. Treated subjects will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.

Last updated: Sep. 8, 2021
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