Clinical Trial

Disease: Relapsed or Refractory Multiple Myeloma, MM, (NCT04960579)

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

Contact:

Angie Schinke

Phone: l858-779-3103 

Email: clinicaltrials@poseida.com

Rajesh Belani, M.D.Vice President, Clinical Development

Sponsor:

Poseida Therapeutics, Inc.

Partners:
Locations:

United States, California

University of California San Diego, San Diego, California, United States, 92093

University of California San Francisco, San Francisco, California, United States, 94143

 

United States, Illinois

Advocate Aurora Health, Park Ridge, Illinois, United States, 66068

 

United States, Iowa
University of Iowa, Iowa City, Iowa, United States, 52242



United States, Kansas
University of Kansas Medical Center, Kansas City, Kansas, United States, 66160

 

United States, Maryland

University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States, 21201

 

United States, Michigan

Wayne State - Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

 

United States, New York
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States, 14263



United States, Ohio 
University of Cincinnati, Cincinnati, Ohio, United States, 45221

 

United States, Oklahoma

University of Oklahoma, Health Sciences Center, Oklahoma City, Oklahoma, United States, 73104

 

United States, Tennessee

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

 

United States, Texas

Sarah Cannon Research Institute - St. David's South Austin Medical Center, Austin, Texas, United States, 78704

Houston Methodist Research Institute, Houston, Texas, United States, 77030

Sarah Cannon Research Institute - Methodist Healthcare, San Antonio, Texas, United States, 78229

Study start:
May. 5, 2022
Enrollment:
135 participants
Gene editing method:
Cas-CLOVER
Type of edit:
Gene knock-out
Gene:
T cell receptor
Delivery method:
Electroporation - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/NCT04960579
Safety updates:

(09-12-2024) Poseida Therapeutics Highlights Positive Interim Phase 1 Results for P-BCMA-ALLO1 and Preclinical Data for Dual CAR-T P-CD19CD20-ALLO1 at the 66th American Society of Hematology (ASH) Annual Meeting

(27-09-2024) Poseida Therapeutics Reports Positive Interim Phase 1 Results for Allogeneic CAR-T Therapy P-BCMA-ALLO1 with High Overall Response Rates in Heavily Pretreated Relapsed/Refractory Multiple Myeloma Patients

(16-09-2024) Poseida Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for P-BCMA-ALLO1 to Treat Relapsed/Refractory Multiple Myeloma

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

Status: Active 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: Dec. 15, 2024
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