Safety and Preliminary Efficacy Study of the Antibody PAT-SM6 in Patients With Relapsed or Refractory Multiple Myeloma

Phase 1 Completed 12 enrolled Patrys Ltd.

NaSingle-groupOpen-labelTreatment

Summary

Primary \- To evaluate the safety and tolerability of escalating doses of an intravenous (i.v.) infusion of PAT-SM6 in subjects with relapsed or refractory multiple myeloma. Secondary * To evaluate the efficacy and pharmacodynamics by analysis of serum and urine M protein, serum free light chains (FLC) κFLC and λFLC, total immunoglobulins, β2-microglobulin, C-reactive protein (CRP), exploratory biomarkers and anti-PAT-SM6 antibodies. * To evaluate the duration of response and the progression free survival.

Timeline

Start: 2012-10
Primary completion: 2014-04
Completion: 2014-04

Outcome

Met primary endpoint

release “PAT-SM6 Multiple Myeloma Phase I/IIa clinical trial hits primary endpoint” patrys.com ↗

Publications

Rasche L, Duell J, Castro IC, Dubljevic V, Chatterjee M, Knop S, Hensel F, Rosenwald A, Einsele H, Topp MS, Brandlein S. GRP78-directed immunotherapy in relapsed or refractory multiple myeloma - results from a phase 1 trial with the monoclonal immunoglobulin M antibody PAT-SM6. Haematologica. 2015 Mar;100(3):377-84. doi: 10.3324/haematol.2014.117945. Epub 2015 Jan 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PAT-SM6	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	PAT-SM6	Monoclonal antibody	1 mg/kg	Intravenous
Subject	PAT-SM6	Monoclonal antibody	3 mg/kg	Intravenous
Subject	PAT-SM6	Monoclonal antibody	6 mg/kg	Intravenous

Indications

No indication recorded.