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Transregional Collaborative Research Centre TR36 ”Principles and Applications of Adoptive T Cell Therapy“ Platform for clinical application of genetically engineered T cells with defined specificity Lutz Uharek / Martin Hildebrandt Z3
description
Transcript of Vortrag sfb tr36 z3 02 14 v100
Transregional Collaborative Research Centre TR36”Principles and Applications of Adoptive T Cell Therapy“
Platform for clinical application of genetically engineered T cells with
defined specificity
Lutz Uharek / Martin Hildebrandt
Z3
Z3
Aim: Translation into Clinic
Industry
legal andregulatory aspects
Z3
GCP
GMP
Introduction
GLP
§
Z3
Road Map
GMP Manufacturing
Risk Assessment
Efficacy Testing
TCR/CAR Selection
Clinical Setting
Safety
Manufacturing License
Laboratory Protocols
Protocol/Ethical Vote
Funding Application Clinical Study
SOP / Validation
GCP Phase I StudyGMP Process
Introduction
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Accomplishments (Berlin – Munich)
Milestone 1 Teams and collaboration tools01-2012
Milestone 2 Definition of target product profiles (TPP) 03-2012
Milestone 3 Project evaluation and priorization06-2012 HMMR
Milestone 4 Description of manufacturing process08-2012
Milestone 5 Phase I Study protocol12-2012
Milestone 6 PEI Advice (positive)02-2013
Milestone 7 Master Cell Banks08-2013
Recent work
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Collaboration in process development
Exchange of documentsContract management
Risk assessmentQuality controls
Vendor qualificationJoint scientific advice
Shared auditsValidation
Joint appointments
HBV-CARagainst HCC
MAGE-A1 TCRagainst MM
Work program
Successful translation
Multiple MyelomaMAGE-A1+
TCR against MAGE-A1
Production ofTCR transduced
T cells
Application ofTCR transduced
T cells
TCR ProductionDisease
not curable with conventional
therapies
tumor susceptible towards T cell
mediated immunity
no expression of MAGE-A1 on healthy
tissues
high effectiveness in vitro and in mouse
model
ATMP (GTMP)production
autologous cells(HLA identical)
Therapy
Phase I
12 patientsrefractory or high risk
disease
Example: Trial I – TCR transduced T cells
Procedural advisory board: Dolores Schendel (preclinical), Hans-Jochem Kolb (clinical)
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Process development (Berlin – Munich)
Milestone 1
Ethic vote, EudraCT Number
06-2013 Definition of TPP and QC
Milestone 2
Clinical trial authorization
06-2014
Milestone 5
Start of clinial trial
09-2015
Phase I protocol and safety board
Milestone 6 10-2015
TCR CAR
11-2013
07-2014
01-2016
02-2016
Work program
Milestone 3 09-2014Validation of GMP Process (EUFETS, SCF, TUMCells)08-2014
IMPD, Manufacturing licenseMilestone 4 05-2015 09-2015
Collaboration within the SFB TR36
A3, A4, A11, B8, B9Development of production
processesDevelopment of clinical protocols
A2Development of TCRs for
clinical use:MAGE-1, NY-ESO
Novel epitopes
A13, A14Pre-clinical safety testing
GMP upscalingRegulatory support
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