GMP Facilities at Karmanos Cancer Institute

Some of our clinical trials at Karmanos Cancer Institute require the manufacturing of a certain type of white blood cell, called a T cell in a clean laboratory environment. These cells are grown and multiplied many times then infused back into the patient. Any product that is manufactured at Karmanos is in accordance with a set of standards determined by the Food and Drug Administration (FDA) called “good manufacturing processes.” Good manufacturing processes ensure that every product administered by Karmanos Cancer Institute will meet quality standards so that the product is safe.

General information on current Good Manufacturing Processes (cGMPs) can be found on the FDA’s website.

General information on immunotherapy treatment 

• U.S. National Institutes of Health’s National Cancer Institute website
• The American Cancer Society
• Multiple Myeloma Research Foundation
• Leukemia & Lymphoma Society
• Leukemia Research Foundation

Scientific publications supporting antibody-targeted cellular immunotherapy treatment options at Karmanos Cancer Institute

1. Lum, L.G., Ramesh, M., Thakur, A., Mitra, S., Deol, A., Uberti, J.P., Pellett, P.E.: Targeting Cytomegalovirus Infected Cells using T-cells Armed with Anti-CD3 x Anti-CMV Bispecific Antibody. Biology of Blood and Marrow Transplantation 18:1012-1022, 2012. PMID: 22313635
2. Yankelevich, M., Kondadasula, S.V., Thakur, A., Buck, S., Cheung, N.V., Lum, L.G.: Anti-CD3 x Anti-GD2 Bispecific Antibody Redirects T-Cell Cytolytic Activity to Neuroblastoma Targets. Pediatr. Blood Cancer, 2012 Jun 15. doi: 10.1002/pbc.24237. [Epub ahead of print]. PMID: 22707078
3. Lum, L.G., Sen, M.: Activated T-cell and bispecific antibody immunotherapy for high-risk breast cancer: Bench to bedside. Acta Haematologica 105:130-136, 2001. PMID: 11463985
4. Sen, M., Wankowski, D.M., Garlie, N.K., Siebenlist, R.E., and Van Epps, D., LeFever, A.V., and Lum, L.G.: Use of anti-CD3 x anti-HER2/neu bispecific antibody for redirecting cytotoxicity of activated T cells toward HER2/neu Tumors, J Hematother Stem Cell Res 10:247-260, 2001. PMID: 11359672 
5.  Ren-Heidenreich, L., Lum, L.G.: Life or death of T cells with antigen-specific receptors – using T cells for cancer adaptive immunotherapy/ gene therapy. Review. Current Gene Therapy 1: 253-255, 2001. PMID: 12109140
6. Lum, L.G., Rathore, R., Cumming, F., Colvin, G.A., Radie-Keane, K, Maizel, A., Quesenberry, P.J., Elfenbein, G. J.: Phase I/II Study of treatment of stage IV breast cancer with OKT3 x Trastuzumab- armed activated T cell. Clinical Breast Cancer 4: 212-217, 2003. PMID: 14499016
7. Lum, L.G., Davol, P.A.: Retargeting T cells and immune effector cells with bispecific antibodies. Book Chapter in: Cancer Chemotherapy & Biological Response Modifiers Annual 22. Giaccone, Schilsky and Sondel (Eds.). UK: Elsevier Limited, 2005, pp 273-291. PMID: 16110617
8. Davol, P.A, Lum, L.G.: How important is HER2/neu amplification and expression when selecting patients for HER2/neu-targeted therapies? Clinical Breast Cancer 5: 70-71, 2004. PMID: 15140288
9. Davol, P.A., Smith, J.A., Kouttab, N., Elfenbein, G.J., Lum, L.G.: Anti-CD3 x anti-HER2 bispecific antibody effectively redirects armed T cells to inhibit tumor development and growth in hormone-refractory prostate cancer-bearing SCID-beige mice. Clinical Prostate Cancer 3(2):112-121, 2004. PMID: 15479495
10. Gall, J.M., Davol, P.A., Grabert, R.C., Deaver, J., Lum, L.G.: T cells armed with anti-CD3 x anti D20 bispecific antibody enhance killing of CD20+ malignant B-cells and bypass complement-mediated rituximab-resistance in vito. Experimental Hematology 33: 452-459, 2005. PMID: 15781336
11. Lum, H.E., Miller, M., Davol, P.A., Grabert, R.C., Davis, J.B., Lum, L.G.: Preclinical studies comparing different bispecific antibodies for redirecting T cell cytotoxicity to extracellular antigens on prostate carcinomas. Anticancer Research 25(1a): 43-52, 2005. PMID: 15816517
12. Lum, L.G., Davol, P.A., Lee, R.J.: The New Face of Bispecific Antibodies: Targeting Cancer and Much More. Experimental Hematology 34:1-6, 2006. PMID: 16413384
13. Reusch, U., Sundarum, M., Davol, P.A., Olson, S.D., Davis, J.B., Demel, K., Nissim, J., Rathore, R., Liu, P.Y., Lum, L.G.: Anti-CD3 x anti-EGFR Bispecific Antibody Redirects T Cell Cytolytic Activity to EGFR-Positive Cancers In Vitro and in an Animal Model. Clinical Cancer Research 12: 183-190, 2006. PMID: 16397041
14. Grabert, R.C., Cousens, L.P., Smith, J.A., Olson, S., Gall, J., Young, W.B., Davol, P.A., Lum, L.G.: Human T Cells Armed with Her2/neu Bispecific Antibodies Divide, Are Cytotoxic, and Secrete Cytokines with Repeated Stimulation. Clinical Cancer Research 12: 569-576, 2006. PMID: 16428502
15. Thakur, A., Lum, L.G.: Cancer therapy with bispecific antibodies. Current Opinion and Molecular Therapeutics (In press).