Investigation of Isatuximab Potential Interference with Single Antigen Bead (SAB) assays and FlowPRA assays for TED16414 Study

Project: Research project

Project Details

Description

Sanofi TED16414 Study - SAB assays

Scope Of Work (SOW)

The Northwestern University - Transplant Immunology Laboratory (NU-TIL) will perform the following

1. Investigation of isatuximab potential interference with Single Antigen Bead (SAB) assays and FlowPRA assays: need to determine details – either we spike sera from 5 patients, or we get sera from Sanofi – before treatment and shortly after first dose (such that there is no antibody reduction expected).
2. NU-TIL will receive patients’ serum samples from Sanofi central lab. Samples will arrive labeled with subject ID and blood collection date, pre-aliquoted, frozen (shipped on dry ice), in batches.
3. Batches will be organized to include specific milestones (to optimize testing schedule):
a. BL (C1D1) samples, 10-12 patients (one sample per patient) per shipment
b. 3 samples at end of treatment period per patient including C2D1/C3D1/FUPweek1, 5-6 patients per shipment
c. 6 follow up samples per patient, including FUP Weeks 5,9,13,17,21,25, 5-6 patients per shipment
4. Tests to be performed include
a. BL (C1D1): SAB 7 tests (neat + 6 titers), for Class I and Class II + Flow PRA.
i. Tests will be analyzed and highest titer for class I and class II antibodies will be entered into data collection file to guide further testing algorithm (personalized per patient).
b. C2D1/C3D1/FUPweek1:3 tests (1 neat + 2 titers) each, Class I and Class II
c. FUPweek1: FlowPRA
d. FUPweeks 5,9,13,17,21,25:3 tests (1 neat + 2 titers) each, Class I and Class II
e. FUPweeks 13,25 – FlowPRA
5. NU-TIL will work with Sanofi to determine format and datapoints to be included in database as well as data transfer specifications (discussions to take place ASAP)
6. Data analysis will be performed within 6-8 weeks from receipt of each batched shipment, with the goal of providing information for data transfer to Sponsor for tentative Early look/interim analyses schedule): Tentative, at least, Nov 2020, February 2021, May 2021, Sept 2021, and end of study (~December 2021).
StatusActive
Effective start/end date8/7/208/7/23

Funding

  • Sanofi-Aventis Recherche et Développement S.A. (Agmt 08/07/20)

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