Cancer Research Translational Initiative (CRTI)

The Cancer Experimental Therapeutics Initiative (CETI) was established in 2008 by Masonic Cancer Center leadership to support translational research and to promote investigator-initiated first-in-human experimental therapeutic trials through investment and specialized infrastructure. CETI has helped MCC researchers translate their work from bench to bedside by offering a comprehensive infrastructure and coordinated integration of services from Masonic Cancer Center shared resources to quickly develop and implement highly complex Phase I clinical trials. 

Shared resources:
Clinical Trials Office (CTO)Clinical Informatics Shared Services (CISS)Translational Therapy Lab (TTL)Molecular and Cellular Therapeutics facility (MCT)Clinical Pharmacology, and Biostatistics.  

CRTI Data Palooza 2021: Data Resources for Population-Based Cancer Research

CRTI Support and Process

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About Us

CETI’s growing portfolio led to the recruitment of a CETI Program Manager, hired in January 2017, to facilitate greater collaboration/partnership between Masonic Cancer Center investigators and pharmaceutical/biotechnology companies for faster development of new therapies for patients. Additionally, in May 2017 CETI Director, Dr. Sarah Cooley, accepted a new Masonic Cancer Center role as Director of Investigator-Initiated Research. This position is designed to provide standardized support for effective translation of both therapeutic and non-therapeutic clinical research.   

In August of 2017, the Data Solutions Group (DSG) was established to provide dedicated expertise to ensure quality in the collection, analysis, integration, and reporting of data for all investigator-initiated clinical trials and studies in the Masonic Cancer Center portfolio. CETI’s success over the last 5 years is exemplified by our support of Phase I therapeutic trials, contributions to enumerable publications, six patents undergoing commercialization and 3 IP licenses to biotech partners arising from CETI-supported MCC work.

CETI funded work has produced a 5X return on investment (total direct awards). CETI has supported clinical trials from two NCI Program Project Grants in the TBT Program (Wagner, Miller) and the successful award of an NCI R35 Outstanding Investigator Award (Miller) focused on solid tumor NK cell immunotherapy. In addition, corporate partners investing into CETI-supported immunotherapy at the University of Minnesota include Fate Therapeutics, Inc., Oxis Biotech, Inc., GT Biopharma, Altor BioScience, Corp., Miltenyi Biotec, Inc. These partnerships provide much-needed support (funding for preclinical development, translation and scale-up, and drugs and cell selection devices for clinical trials) to augment NCI funding.

Building on the successful model of CETI, Masonic Cancer Center established Cancer Research Translational Initiative (CRTI) in Nov/2017 to support investigator-initiated studies from the areas of Cancer Prevention and Control, Population Research, and Biomarker Discovery. CRTI will include both therapeutic and non-therapeutic research and thus, will support all investigator-initiated translational research in the Masonic Cancer Center.

CRTI Support

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CRTI Translation Process

Masonic Cancer Center Tranlastion Process infographics

CRTI Research

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CRTI Supported Clinical Trials

MT2010-07R A Phase II Trial of GnRH agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)
MT2003-15 Use of Cyclophosphamide/Fludarabine to Promote in vivo Expansion of Donor Lymphocyte Infusions (DLI) to Enhance Efficacy after Allogeneic Transplant
MT2006-24 Total Marrow Irradiation and Myeloablative Chemotherapy Followed by Double Umbilical Cord Blood Transplantation in Patients with Refractory Acute Leukemia
MT2006-01 Phase I Study of Infusion of Umbilical Cord Blood (UCB) Derived CD25+ CD4+ T-Regulatory (Treg) Cells After Non-Myeloablative Cord Blood Transplantation
A Phase I/II Trial of Short Course Pre Operative Ritonavir To Determine Akt Inhibition in Breast Cancer
MT2009-15 Lymphodepleting Chemotherapy with Rituximab and Allogeneic Natural Killer Cells for Patients with Refractory Lymphoid Malignancies
Pilot Study of Imiquimod and Tumor Lysate Vaccine Immunotherapy for Diffuse Intrinsic Pontine Glioma in Children and young Adults
MT2010-06 KIR Genotyping for Unrelated Donor (URD) Selection Prior to Hematopoietic Cell Transplantation (HCT) for AML: Selecting a Favorable KIR Donor
HM2010-05 Phase I Open Label, Single Arm, Dose Escalation Trial to Evaluate the Biodistribution and Safety of AHN-12 In Patients with Advanced Leukemia
MT2010-10 Haploidentical Donor Natural Killer (NK) Cell Infusion with Intravenous Recombinant Human IL-15 (rhIL-15) in Adults with Refractory or Relapsed Acute Myelogenous Leukemia (AML)
MT2012-06 Dose Escalation Study with Extension of Inducible Regulatory T Cells (iTregs) in Adult Patients Undergoing Non-Myeloablative HLA-Identical Sibling Donor Peripheral Blood Stem Cell Transplantation
MT2011-05: Multi-Center Phase II Trial of NK Cell Based Non-Myeloablative Haploidentical Transplantation for Patients with High-Risk Acute Myeloid Diseases
A Randomized, Double-Blind Phase II Study of Sipuleucel-T (Provenge®) Followed by Indoximod or Placebo in the Treatment of Patients with Asymptomatic or Minimally Symptomatic Metastatic Castration Resistant Prostate Cancer
MT2012-04 Decitabine and Vorinostat with CD3/CD19 Depleted Haploidentical Donor Natural Killer (NK) Cells for the Treatment of High Risk Myelodysplastic Syndromes (MDS)
HM2012-05: A Phase II Trial Investigating Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia
HM2013-12: IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic Stem Cell Transplantation
HM2013-16 A Phase 1 Study of DT2219ARL: A Bispecific SIngle Chain Immunotoxin for the Treatment of CD19+, CD22+ B-lineage Leukemia or Lymphoma
MT2013-11: Indoleamine-2,3-dioxygenase (IDO) Inhibition with INCB024360 and Intraperitoneal Delivery of Allogeneic Natural Killer Cells for Women with Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer
MT2014-23R: Prevention of Bone Loss after Pediatric Hematopoietic Cell Transplantation
HM2013-24: Study of the ADAM17 Inhibitor INCB7839 Combined With Rituximab After Autologous Hematopoietic Cell Transplantation (HCT) For Patients With Diffuse Large B Cell Non-Hodgkin Lymphoma (DLBCL)
MT2014-12:Phase I/II Study of Human Chorionic Gonadotropin and Epidermal Growth Factor Supplementation (Pregnyl®) to Support Tolerance and Repair As Adjunct Therapy in High-Risk or Refractory Acute Graft-Versus-Host Disease
MT2014-25: A Phase 2 Study of Subcutaneous Recombinant Human IL-15 (rhIL-15) and Haploidentical Donor Natural Killer (NK) Cell Infusion in Adults with Refractory or Relapsed Acute Myelogenous Leukemia
HM2014-26 DT2219 immunotoxin for the treatment of relapsed or refractory CD19 (+) and/or CD 22 (+) B-lineage leukemia or lymphoma
Investigation of kava effects on the metabolism of the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in humans
MT2015-20: Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Cell Transplantation and Serial Donor Mesenchymal Cell Infusions
Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women with Advanced Non-Small Cell Lung Cancer
MT2015-36 : Study of Epidermal Grafting Using the CelluTome Epidermal Harvesting System for the Treatment of Individual Lesions in persons with Epidermolysis Bullosa
Phase 2 Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors
MT2016-05 :Haploidentical Donor Natural Killer (NK) Cell Infusion with Subcutaneous ALT-803 in Adults with Refractory or Relapsed Acute Myelogenous Leukemia
MT2016-07 : Relapse Prophylaxis with IL-15 Super Agonist ALT-803 in Patients with Acute Myelogenous Leukemia and Myelodysplastic Syndrome Following Allogeneic Stem Cell Transplantation
MT2016-17 Adoptive Transfer of T Regulatory Cell with IL-2 Support for Suppression of Acute Graft-vs- Host-Disease after a Double Umbilical Cord Blood Transplant for Hematologic Malignancies
MT2016-27 Open Label Dose Escalation Trial of an Adaptive Natural Killer (NK) Cell Infusion (FATE-NK100) with Subcutaneous IL-2 in Adults with Refractory or Relapsed Acute Myelogenous Leukemia (AML)

Grants awarded to CETI Funded Projects

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Receptor Targeting Agents      
STATUS - Issued January 7, 2016
Patent Number: 9,155,798    
Inventors: Vallera,Daniel A. (Richfield MN)
Commercialization Status: Oxis Biotech Inc. Plans to commercialize

Methods and Compositions for Bi-specific Targeting of CD19/CD22-
STATUS: Issued, 2016
Inventors: Vallera, Daniel A. (Richfield MN, MN); Jeff Lion (Fresno, CA)
Commercialization Status: Patent has been Licensed by Oxis and Oxis is the new clinical trial sponsor

Single-Chain Variable Fragment anti-CD133 Antibodies and Uses Thereof
Patent Number: 20130224202
Inventors:Ohlfest; John R.; (Minneapolis, MN) ; Panyam; Jayanth; (Plymouth, MN) ; Swaminathan; Suresh Kumar; (Minneapolis, MN) ; Vallera; Daniel A.; (St. Louis Park, MN)
Commercialization Status: Oxis Plans to commercialize

Deimmunized Therapeutic Compositions and Methods
STATUS: Provisional Patent Filed
Patent Number: 62236568
Inventors: Vallera, Daniel A. (Richfield MN)
Commercialization Status: Oxis Plans to commercialize

Therapeutic Compounds and Methods
STATUS: Provisional Patent Filed
Patent Number: 62237835
Inventors: Vallera, Daniel A. (Richfield MN); Jeffrey S. Miller
Commercialization Status: Oxis Plans to commercialize



1. Schmohl JU, Felices M, Oh F, Lenvik AJ, Lebeau AM, Panyam J, Miller JS, Vallera DA. Engineering of Anti-CD133 Tri-Specific Molecule Capable of Inducing NK Expansion and Driving Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC). Cancer Res Treat. 2017 Feb 20. PMID: 28231426

2. Borgatti A, Koopmeiners JS, Sarver AL, Winter AL, Stuebner K, Todhunter D, Rizzardi AE, Henriksen JC, Schmechel S, Forster CL, Kim JH, Froelich J, Walz J, Henson MS, Breen M, Lindblad-Toh K, Oh F, Pilbeam K, Modiano JF, Vallera DA. Safe and Effective Sarcoma Therapy through Bispecific Targeting of EGFR and uPAR. Mol Cancer Ther. 2017 May;16(5):956-965. PMID: 28193671

3. Rashidi A, Ali AM, Vij KR, Shanley R, Romee R, Cooley SA, Westervelt P, DiPersio JF, Miller JS, Weisdorf DJ, Ustun C. Allogeneic hematopoietic cell transplantation in morphologic leukemia-free aplastic state. Am J Hematol. 2017 Sep;92(9):E549-E552. PMID: 28568483

4. Ustun C, Williams S, Skendzel S, Kodal B, Arock M, Gotlib J, Vallera DA, Cooley S, Felices M, Weisdorf D, Miller J. Allogeneic NK cells eradicate myeloblasts but not neoplastic mast cells in systemic mastocytosis associated with acute myeloid leukemia.Am J Hematol. 2017 May;92(5):E66-E68. PMID: 28187525.

5. Fair C, Shanley R, Rogosheske J, Lazaryan A, McClune B, Brunstein CG, Bachanova V. BEAM conditioning is well-tolerated and yields similar survival in obese and non-obese patients with lymphoma: no requirement for weight-based dose modifications. Bone Marrow Transplant. 2017 Mar;52(3):491-493. PMID: 28067889.

6. Touma W, Brunstein CG, Cao Q, Miller JS, Curtsinger J, Verneris MR, Bachanova V. Dendritic Cell Recovery Impacts Outcomes after Umbilical Cord Blood and Sibling Donor Transplantation for Hematologic Malignancies. Biol Blood Marrow Transplant. 2017 Jul 17. pii: S1083-8791(17)30578-5. PMID: 28729150.

7. Hui S, Brunstein C, Takahashi Y, DeFor T, Holtan SG, Bachanova V, Wilke C, Zuro , Ustun C2, Weisdorf D, Dusenbery K, Verneris MR. Dose Escalation of Total Marrow Irradiation in High-Risk Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2017 Jul;23(7):1110-1116. PMID: 28396164.

8. Hegerova L, Cao Q, Lazaryan A, McClune BL, Weisdorf DJ, Brunstein CG, Bachanova V. Improving outcomes after allogeneic hematopoietic cell transplantation for Hodgkin lymphoma in the brentuximab vedotin era. Bone Marrow Transplant. 2017 May;52(5):697-703. PMID: 28134921.

9. Hippen KL, O'Connor RS, Lemire AM, Saha A, Hanse EA, Tennis NC,  Blazar BR. (2017). In Vitro Induction of Human Regulatory T Cells Using Conditions of Low Tryptophan Plus Kynurenines. American Journal of Transplantation. DOI: 10.1111/ajt.14338. PMID: 28470889

10. He F, Verneris MR, Cooley S, Blazar BR, MacMillan ML, Newell LF,  Holtan SG. (2017). Low day +100 serum epidermal growth factor levels are associated with acute GvHD after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation. 52(2), 301-303. DOI: 10.1038/bmt.2016.261. PMID: 27869812.

11. Davis, Z. B., Vallera, D. A., Miller, J. S., & Felices, M. (2017). Natural killer cells unleashed: Checkpoint receptor blockade and BiKE/TriKE utilization in NK-mediated anti-tumor immunotherapy. Seminars in Immunology. DOI: 10.1016/j.smim.2017.07.011. PMID: 28882429.

12. Hoff, G. A., Fischer, J. C., Hsu, K., Cooley, S., Miller, J. S., Wang, T., ... Verneris, M. R. (2017). Recipient HLA-C Haplotypes and microRNA 148a/b Binding Sites Have No Impact on Allogeneic Hematopoietic Cell Transplantation Outcomes. Biology of Blood and Marrow Transplantation, 23(1), 153-160. DOI: 10.1016/j.bbmt.2016.09.028. PMID: 27746218.

13. Merryman, R. W., Kim, H. T., Zinzani, P. L., Carlo-Stella, C., Ansell, S. M., Perales, M. A., Armand, P. (2017). Safety and efficacy of allogeneic hematopoietic stem cell transplant after PD-1 blockade in relapsed/refractory lymphoma. Blood, 129(10), 1380-1388. DOI: 10.1182/blood-2016-09-738385. PMID: 28073785.

14. Boland, P. J., Hegerova, L. T., Williams, S. J., McKenna, R. W., Bachanova, V., & Eckfeldt, C. E. (2017). Successful treatment of two cases of classical Hodgkin lymphoma-associated hemophagocytic lymphohistiocyosis with R-CEPP. Leukemia and Lymphoma, 58(2), 478-481. DOI: 10.1080/10428194.2016.1193857. PMID: 27339158.


1. Schmohl JU, Felices M, Todhunter D, Taras E, Miller JS, Vallera DA. Tetraspecific scFv construct provides NK cell mediated ADCC and self-sustaining stimuli via insertion of IL-15 as a cross-linker. Oncotarget. 2016 Nov 8;7(45):73830-73844. PMID: 27650544

2. Schmohl JU, Vallera DA. CD133, Selectively Targeting the Root of Cancer. Toxins (Basel). 2016 May 28;8(6). pii: E165. Review. PMID: 27240402

3. Felices M, Lenvik TR, Davis ZB, Miller JS, Vallera DA. Generation of BiKEs and TriKEs to Improve NK Cell-Mediated Targeting of Tumor Cells. Methods Mol Biol. 2016;1441:333-46. PMID: 27177679

4. Schmohl JU, Felices M, Taras E, Miller JS, Vallera DA. Enhanced ADCC and NK Cell Activation of an Anticarcinoma Bispecific Antibody by Genetic Insertion of a Modified IL-15 Cross-linker. Mol Ther. 2016 Aug;24(7):1312-22. PMID: 27157665

5. Vallera DA, Felices M, McElmurry R, McCullar V, Zhou X, Schmohl JU, Zhang B, Lenvik AJ, Panoskaltsis-Mortari A, Verneris MR, Tolar J, Cooley S, Weisdorf DJ, Blazar BR, Miller JS. IL15 Trispecific Killer Engagers (TriKE) Make Natural Killer Cells Specific to CD33+ Targets While Also Inducing Persistence, In Vivo Expansion, and Enhanced Function. Clin Cancer Res. 2016 Jul 15;22(14):3440-50. PMID: 26847056

6. He F, Warlick E, Miller JS, MacMillan M, Verneris MR, Cao Q, Weisdorf D (2016). Lymphodepleting chemotherapy with donor lymphocyte infusion post-allogeneic HCT for hematological malignancies is associated with severe, but therapy-responsive aGVHD. Bone Marrow Transplantation. 51(8):1107-12. PMID: 27064686.

7. Brunstein CG, Miller JS, McKenna DH, Hippen KL, DeFor TE, Sumstad D, Curtsinger J, Verneris MR, MacMillan ML, Levine BL, Riley JL, June CH, Le C, Weisdorf DJ, McGlave PB, Blazar BR, Wagner JE (2016). Umbilical cord blood-derived T regulatory cells to prevent GVHD: kinetics, toxicity profile, and clinical effect. Blood127(8):1044-51 PMID: 26563133.

8. Schmohl JU, Felices M, Todhunter D, Taras E, Miller JS, Vallera DA (2016). Tetraspecific scFv construct provides NK cell mediated ADCC and self-sustaining stimuli via insertion of IL-15 as a cross-linker. Oncotarget. PMID: 27650544.

9. Schmohl JU, Felices M, Taras E, Miller JS, Vallera DA (2016). Enhanced ADCC and NK Cell Activation of an Anticarcinoma Bispecific Antibody by Genetic Insertion of a Modified IL-15 Cross-linker. Mol Ther. 24(7):1312-22. PMID: 27157665.


1. Bachanova V, Frankel AE, Cao Q, Lewis D, Grzywacz B, Verneris MR, Ustun C, Lazaryan A, McClune B, Warlick ED1, Kantarjian H, Weisdorf DJ, Miller JS, Vallera DA (2015). Phase I Study of a Bispecific Ligand-Directed Toxin Targeting CD22 and CD19 (DT2219) for Refractory B-cell Malignancies. Clin Cancer Res.; 21(6):1267-72. PMID: 25770294.

2. Cichocki F, Cooley S, Davis Z, DeFor TE, Schlums H, Zhang B, Brunstein CG, Blazar BR,   Wagner J, Diamond DJ, Verneris MR, Bryceson YT, Weisdorf DJ, Miller JS (2015). CD56dimCD57+NKG2C+ NK cell expansion is associated with reduced leukemia relapse after reduced intensity HCT. Leukemia. Sep 29.10.1038/leu.2015.260. PMID: 26416461.

3. Schmohl JU, Gleason MK, Dougherty PR, Miller JS, Vallera DA (2015). Heterodimeric Bispecific Single Chain Variable Fragments (scFv) Killer Engagers (BiKEs) Enhance NK-cell Activity Against CD133+ Colorectal Cancer Cells. Schmohl J, Gleason M,  Dougherty P, Miller JS, Vallera D. Target Oncol. PMID: 26566946.


1. Gleason MK, Ross J, Warlick E, Lund T, Verneris MR, Wiernik A, Spellman S, Haagenson MD, Lenvik, A, Litzow M, Blazar B, Burnette PK, Weiner L, Weisdorf D, Vallera DA, Miller JS  (2014).  CD16xCD33 bispecific killer cell engager (BiKE) activates NK cells from MDS patients against primary MDS and MDSC CD33+ target. Blood. 123(19):3016-26. PMID: 24652987.

2. Bachanova V, Cooley S, Defor T, Verneris MR, Zhang B, McKenna D, Curtsinger J, Panoskaltsis-Mortari A, Lewis D, Hippen K, McGlave P, Weisdorf  D, Blazar B, Miller JS (2014). Clearance of acute myeloid leukemia by haploidentical natural killer cells is improved using IL-2 diphtheria toxin fusion protein. Blood. 123(25):3855-63. PMID: 24719405.

3. Burke M, Lamba J, Pounds S, Cao X, Puranaik YG, Lindgren B, Weigel B, Verneris M, Miller JS (2014). A Therapeutic Trial of Decitabine and Vorinostat in Combination with Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia. Am J Hematol. 89(9):889-95. PMID: 24891274.


1. Karras NA, Weeres M, Sessions W, Xu X, Defor T, Young JA, Stefanski H, Brunstein C, Cooley S, Miller JS, Blazar BR, Waner JE, Verneris MR (2013).  A randomized trial of one versus two doses of influenza vaccine after allogeneic transplantation. Biol Blood Marrow Transplant. 19(1):109-116. PMID: 22940056.

2. Koepsell SA, Kadidlo DM, Fautsch S, McCullough J, Klingemann H, Wagner JE, Miller JS, McKenna DH Jr. (2013).  Successful “in-flight” activation of natural killer cells during long-distance shipping. Transfusion. 53(2):398-403. PMID: 22574659.

3. Romee R, Foley B, Lenvik T, Wang Y, Zhang B, Ankarlo D, Luo X, Cooleye S, Verneris M, Walcheck, Miller JS (2013). NK cell CD16 surface expression and function is regulated by a disintegrin and metalloprotease-17 (ADAM 17). Blood. 121(18): 3599-608. PMID: 23487023.

4. Sawitzki B, Brunstein C, Meisel C, Schumann J, Vogt K, Appelt C, Curtsinger JM, Verneris MR, Miller JS, Wagner JE, Blazar B (2013). Prevention of GVHD by adoptive T regulatory therapy is associated with active repression of peripheral blood toll-like receptor-5 mRNA expression. Biol Blood Marrow Transplant. (2):173-82, 2013. PMID: 24184334.

5. Geller MA, Knorr DA, Hermanson DA, Pribyl L, Bendzick L, McCullar V, Miller JS, Kaufman DS (2013). Intraperitoneal delivery of human natural killer cells for treatment of ovarian cancer in a mouse xenograft model. Cytotherapy. (10):1297-306. PMID: 23993303.

6. Brunstein CG, Blazar BR, Miller JS, Cao Q, Hippen KL, McKenna DH, Curtsinger J, McGlave PB, Wagner JE (2013). Adoptive transfer of umbilical cord blood-derived regulatory T cells and early viral reactivation. Biol Blood Marrow Transplant. (8):1271-3.  PMID:23806771.

7. Wiernik A, Foley B, Zhang B, Verneris MR, Warlick E, Gleason MK, Ross JA, Luo X, Weisdorf DJ, Walcheck B, Vallera DA, Miller JS (2013). Targeting natural killer cells to acute myeloid leukemia in vitro with a CD16 x 33 bispecific killer cell engager and ADAM17 inhibition. Clin Cancer Res. (14):3844-55. PMID: 23690482.

8. Vallera DA, Zhang B, Gleason MK, Oh S, Weiner LM, Kaufman DS, McCullar V, Miller JS, Verneris MR (2013). Heterodimeric Bispecific Single-Chain Variable-Fragment Antibodies Against EpCAM and CD16 Induce Effective Antibody-Dependent Cellular Cytotoxicity Against Human Carcinoma Cells. Cancer Biother Radiopharm. (4):274-82, 2013. PMID: 23611188.