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Numeric Expansion of CD-19 Specific T cells in Magnetic 3D Culture

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI136225-01
Agency Tracking Number: R41AI136225
Amount: $175,849.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-02-01
Award End Date (Contract End Date): 2020-01-31
Small Business Information
6611 MORNINGSIDE DR
Houston, TX 77030-1905
United States
DUNS: 827741336
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 HUBERT TSENG
 (760) 448-1168
 htseng5@gmail.com
Business Contact
 GLAUCO SOUZA
Phone: (713) 790-1833
Email: gsouza@n3dbio.com
Research Institution
 UNIVERSITY OF TX MD ANDERSON CAN CTR
 
1515 HOLCOMBE BLVD
HOUSTON, TX 77030-4009
United States

 Nonprofit College or University
Abstract

Project Summary
Adoptive immunotherapy trials using genetically modified natural killerNKand T cells with redirected specificity
against B cell malignancies have demonstrated therapeutic efficacyTwo early phase clinical trials have been
initiated at The University of Texas MDAnderson Cancer Center to evaluate the safety and efficacy of adoptive
transfer of autologous and allogeneic T cells expressing a CDspecific chimeric antigen receptorCARinto
patients with advanced B cell malignanciesThese CDspecific CART cells are selectively propagated in
vitro in the presence of irradiated artificial antigen presenting cellsaAPCexpressing co stimulatory molecules
that sustain their proliferation to clinically sufficient numbers in compliance with current good manufacturing
practicecGMPfor Phase I II trialsThis conventional culturing process requiresdays to generate the
required andgtCART cells for each infusionReduction of the time required to generate clinically sufficient
numbers in tissue culture will reduce manufacturing costs significantly and will yield a clinical product
in which the CART cells have increased replicative potential and are less differentiatedTo enhance the
production processwe propose to develop novel co culture protocol that utilizes magnetic co levitation to
increase the contact interface between CARNK or T cells and the stimulating aAPCs to significantly improve
the kinetics of numeric expansion of CARlymphocytes with desired specificity and preservation of memory
phenotypeOur long term goal is to develop a cGMP compliant protocol based on three dimensionalDmagnetic levitation co cultures for the rapid and specific production of CART and NK cells to support ongoing
immunotherapy trialsOur novel expansion method is based on the central hypothesis that increasing the
number and duration of contact points between CART or NK cells and aAPCs will accelerate the proliferation
of the targeting cellsyielding clinically sufficient number of cells in less timeIn this Phase I SBIR proposalwe
aim to develop and optimizeD cell magnetic levitation co culture conditions to improve the propagation of CART cells by magnetic nanoparticle labeling of aAPCsNKand T cells and co culturing inD to maximize expansion
of the genetically modified CDspecific NK and T cellsDevelopment of this expansion methodology will
significantly impact the treatmentmanagementand cost of adoptive cell therapies of B cell malignancies Narrative
Adoptive T cell therapy offers a promising approach for treating B cell malignanciesThe
process of preparing these targeting T cells for transplantation involves isolation of
antigen specific cells and expansion in vitro in the presence of target antigenThe
process of preparing these cells is lengthytaking up todaysIt is recognized that
reducing the preparation time in culture will save manufacturing costs will yield less
differentiated T cells that have increased targeting potentialThe proposed work will
implement and optimize T cell expansion methods that are based on magnetically
levitated cell cultures to produce clinically sufficient number of T cells in one third of the
time required to manufacture by conventional methods

* Information listed above is at the time of submission. *

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