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1. Long-term follow-up for the development of subsequent malignancies in patients treated with genetically modified IECs

Author

Steffin, David H.M., Muhsen, Ibrahim N., Hill, LaQuisa C., Ramos, Carlos A., Ahmed, Nabil, Hegde, Meenakshi, Wang, Tao, Wu, Mengfen, Gottschalk, Stephen, Whittle, Sarah B., Lulla, Premal D., Mamonkin, Maksim, Omer, Bilal, Rouce, Rayne H., Heczey, Andras, Metelitsa, Leonid S., Grilley, Bambi J., Robertson, Catherine, Torrano, Virginia, Lapteva, Natalia, Gee, Adrian P., Rooney, Cliona M., Brenner, Malcolm K., and Heslop, Helen E.

Published
2022
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3. Donor-derived multiple leukemia antigen–specific T-cell therapy to prevent relapse after transplant in patients with ALL

Author

Naik, Swati, primary, Vasileiou, Spyridoula, additional, Tzannou, Ifigeneia, additional, Kuvalekar, Manik, additional, Watanabe, Ayumi, additional, Robertson, Catherine, additional, Lapteva, Natalia, additional, Tao, Wang, additional, Wu, Mengfen, additional, Grilley, Bambi, additional, Carrum, George, additional, Kamble, Rammurti T., additional, Hill, LaQuisa, additional, Krance, Robert A., additional, Martinez, Caridad, additional, Tewari, Priti, additional, Omer, Bilal, additional, Gottschalk, Stephen, additional, Heslop, Helen E., additional, Brenner, Malcom K., additional, Rooney, Cliona M., additional, Vera, Juan F., additional, Leen, Ann M., additional, and Lulla, Premal D., additional

Published
2022
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4. Donor-Derived Adoptive T-Cell Therapy Targeting Multiple Tumor Associated Antigens to Prevent Post-Transplant Relapse in Patients with ALL

Author

Naik, Swati, primary, Vasileiou, Spyridoula, additional, Tzannou, Ifigeneia, additional, Kuvalekar, Manik, additional, Watanabe, Ayumi, additional, Robertson, Catherine, additional, Gee, Adrian P., additional, Grilley, Bambi J., additional, Carrum, George, additional, Kamble, Rammurti, additional, Hill, LaQuisa C., additional, Krance, Robert A., additional, Martinez, Caridad A., additional, Omer, Bilal, additional, Gottschalk, Stephen, additional, Heslop, Helen E., additional, Rooney, Cliona M., additional, Vera, Juan, additional, Leen, Ann, additional, and Lulla, Premal D., additional

Published
2021
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5. CD70-specific CAR T cells have potent activity against acute myeloid leukemia without HSC toxicity

Author

Sauer, Tim, primary, Parikh, Kathan, additional, Sharma, Sandhya, additional, Omer, Bilal, additional, Sedloev, David, additional, Chen, Qian, additional, Angenendt, Linus, additional, Schliemann, Christoph, additional, Schmitt, Michael, additional, Müller-Tidow, Carsten, additional, Gottschalk, Stephen, additional, and Rooney, Cliona M., additional

Published
2021
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6. Treatment of Severe, Drug-Refractory Viral Infections with Allogeneic, Off-the-Shelf Multi-Virus Specific T Cells in Patients Following HSCT: Results from a Phase 2 Study

Author

Tzannou, Ifigeneia, primary, Watanabe, Ayumi, additional, Papadopoulou, Anastasia, additional, Kuvalekar, Manik, additional, Naik, Swati, additional, Lulla, Premal, additional, Krance, Robert A., additional, Ramos, Carlos A., additional, Heslop, Helen E., additional, Leen, Ann M., additional, and Omer, Bilal, additional

Published
2020
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9. Long Term Follow-up for the Development of Subsequent Malignancies in Patients Treated with Genetically Modified IEs

Author

Steffin, David H.M., Muhsen, Ibrahim N., Hill, LaQuisa C, Ramos, Carlos A., Ahmed, Nabil, Hegde, Meena, Wang, Tao, Wu, Mengfen, Gottschalk, Stephen, Whittle, Sarah B., Lulla, Premal D., Mamonkin, Maksim, Omer, Bilal, Rouce, Rayne H, Heczey, Andras, Metelitsa, Leonid S., Grilley, Bambi J, Robertson, Catherine, Torrano, Virginia, Lapteva, Natasha, Gee, Adrian P, Rooney, Cliona M., Brenner, Malcolm K., and Heslop, Helen E.

Abstract

Subsequent malignancies are well-documented complications in long-term follow-up of cancer patients. Recently, genetically modified immune effector cells (IECs) have showed benefit in hematologic malignancies and are being evaluated in clinical trials for solid tumors. While the short-term complications of IECs are well described, there is limited literature summarizing long-term follow-up, including subsequent malignancies. We retrospectively reviewed data from 340 patients treated across 27 investigator-initiated pediatric and adult clinical trials at our center. All patients received IECs genetically modified with gamma-retroviral vectors to treat relapsed and/or refractory hematologic or solid malignancies. In a cumulative 1,027 years of long-term follow-up, 13 patients (3.8%) developed another cancer with a total of 16 events (four hematologic malignancies and 12 solid tumors). The 5-year cumulative incidence of a first subsequent malignancy in the recipients of genetically modified IECs was 3.6% (95% CI: 1.8%-6.4%). For 11 of the 16 subsequent tumors, biopsies were available, and no sample was transgene positive by PCR. Replication competent retrovirus testing of peripheral blood mononuclear cells was negative in the 13 patients with subsequent malignancies tested. Rates of subsequent malignancy were low and comparable to standard chemotherapy. These results suggest that the administration of IECs genetically modified with gamma retroviral vectors does not increase the risk for subsequent malignancy.

Published
2024
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10. Safety and Preliminary Efficacy of "Ready to Administer" Cytomegalovirus (CMV)-Specific T Cells for the Treatment of Patients with Refractory CMV Infection

Author

Tzannou, Ifigeneia, primary, Leung, Kathryn S., additional, Martinez, Caridad, additional, Naik, Swati, additional, Gottschalk, Stephen, additional, Gee, Adrian P., additional, Grilley, Bambi, additional, Watanabe, Ayumi, additional, Leen, Ann M., additional, Kakarla, Sunitha, additional, and Omer, Bilal, additional

Published
2016
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11. Administration of Most Closely HLA-Matched Multivirus-Specific T Cells for the Treatment of EBV, CMV, AdV, HHV6, and BKV Post Allogeneic Hematopoietic Stem Cell Transplant

Author

Tzannou, Ifigeneia, primary, Papadopoulou, Anastasia, additional, Watanabe, Ayumi, additional, Kuvalekar, Manik, additional, Gee, Adrian P., additional, Naik, Swati, additional, Martinez, Caridad, additional, Leung, Kathryn S., additional, Sasa, Ghadir S., additional, Krance, Robert A., additional, Carrum, George, additional, Ramos, Carlos A., additional, Grilley, Bambi, additional, Brenner, Malcolm K., additional, Rooney, Cliona M., additional, Heslop, Helen E, additional, Leen, Ann M., additional, and Omer, Bilal, additional

Published
2016
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12. Administration of Most Closely HLA-Matched Multivirus-Specific T Cells for the Treatment of EBV, CMV, AdV, HHV6, and BKV Post Allogeneic Hematopoietic Stem Cell Transplant

Author

Omer, Bilal, primary, Papadopoulou, Anastasia, additional, Koottiyaniyil, Nikita, additional, Gee, Adrian P., additional, Naik, Swati, additional, Marinez, Caridad, additional, Kathryn, Leung, additional, Sasa, Ghadir S., additional, Krance, Robert A., additional, Grilley, Bambi, additional, Brenner, Malcolm K., additional, Rooney, Cliona M., additional, Heslop, Helen E., additional, Leen, Ann M., additional, and Tzannou, Ifigeneia, additional

Published
2015
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13. Adoptively-Transferred EBV-Specific T Cells to Prevent or Treat EBV-Related Lymphoproliferative Disease in Allogeneic HSCT Recipients - a Single Center Experience Spanning 22 Years

Author

Tzannou, Ifigeneia, primary, Omer, Bilal, additional, Papadopoulou, Anastasia, additional, Gerdemann, Ulrike, additional, Smith, Colton, additional, Gee, Adrian P., additional, Grilley, Bambi J, additional, Brenner, Malcolm K., additional, Bollard, Catherine M., additional, Leen, Ann M., additional, Rooney, Cliona M., additional, and Heslop, Helen E., additional

Published
2015
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14. Donor-Derived Multiple Leukemia Antigen Specific T-cell Therapy to Prevent Relapse Post-Transplant in Patients with ALL

Author

Naik, Swati, Vasileiou, Spyridoula, Tzannou, Ifigeneia, Kuvalekar, Manik, Watanabe, Ayumi, Robertson, Catherine, Lapteva, Natalia, Tao, Wang, Wu, Mengfen, Grilley, Bambi, Carrum, George, Kamble, Rammurti T., Hill, LaQuisa, Krance, Robert A., Martinez, Caridad, Tewari, Priti, Omer, Bilal, Gottschalk, Stephen, Heslop, Helen E., Brenner, Malcom K., Rooney, Cliona M., Vera, Juan F., Leen, Ann M., and Lulla, Premal D.

Abstract

Hematopoietic stem cell transplant (HSCT) is a curative option for patients with high-risk acute lymphoblastic leukemia (ALL) but relapse remains a major cause of treatment failure. To prevent disease relapse, we prepared and infused donor-derived multiple leukemia-antigen specific T-cells (mLSTs) targeting PRAME, WT1, and Survivin,leukemia-associated antigens that are frequently expressed in B- and T-ALL. Our goal was to maximize graft-versus-leukemia (GvL) effect while minimizing the risk of graft-versus-host disease (GVHD). We administered mLSTs (doses range: 0.5-2x107/m2)to 11 ALL patients (8 pediatric, 3 adult), and observed no dose-limiting toxicity, acute GVHD, cytokine release syndrome or other adverse events. Six of 8 evaluable patients remain in long-term complete remission (median: 46.5 [range: 9-51] months). In these individuals we detected an increased frequency of tumor-reactive T cells shortly after infusion, with activity against both targeted and non-targeted known tumor-associated antigens indicative of in vivoantigen spreading. By contrast,this in vivoamplification was absent in the two patients who relapsed. In summary, infusion of donor-derived mLSTs post allogeneic HSCT is feasible, safe and may contribute to disease control as evidenced by in vivotumor-directed T cell expansion. Thus, this approach represents a promising strategy to prevent relapse in ALL patients.

Published
2022
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15. CD70-specific CAR T-cells have potent activity against Acute Myeloid Leukemia (AML) without HSC toxicity

Author

Sauer, Tim, Parikh, Kathan, Sharma, Sandhya, Omer, Bilal, Sedloev, David, Chen, Qian, Angenendt, Linus, Schliemann, Christoph, Schmitt, Michael, Müller-Tidow, Carsten, Gottschalk, Stephen, and Rooney, Cliona M.

Abstract

The prognosis of patients with acute myeloid leukemia (AML) remains dismal highlighting the need for novel innovative treatment strategies. The application of chimeric antigen receptor (CAR) T-cell therapy to AML patients has been limited in particular by the lack of a tumor-specific target antigen. CD70 is a promising antigen to target AML as it is expressed on the majority of leukemic blasts, whereas little or no expression is detectable in normal bone marrow samples. To target CD70 on AML cells, we generated a panel of CD70-CARs that contained a common single chain variable fragment (scFv) for antigen detection but differed in size and flexibility of the extracellular spacer, and in the transmembrane and the co-stimulatory domains. These CD70scFv CARs were compared with a CAR construct that contained the human CD27, the ligand of CD70 fused to the CD3ζ chain (CD27z). The structural composition of the CAR strongly influenced expression levels, viability, expansion and cytotoxic capacities of CD70scFv CAR T-cells, but the CD27z-CAR T-cells demonstrated superior proliferation and anti-tumor activity in vitroand in vivo, compared to all CD70scFv-CARs. While CD70-CAR T-cells recognized activated virus-specific T-cells (VSTs) that expressed CD70, they did not prevent colony formation by normal hematopoietic stem cells (HSCs). Thus, CD70-targeted immunotherapy is a promising new treatment strategy for patients with CD70-positive AML that does not affect normal hematopoiesis but will require monitoring of virus-specific T-cell responses.

Published
2021
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16. Adoptive Immunotherapy with Rapidly-Generated Multivirus-Specific T Cells Against AdV, EBV, CMV, HHV6 and BK after Allogeneic Hematopoietic Stem Cell Transplant

Author

Tzannou, Ifigeneia, Papadopoulou, Anastasia, Watanabe, Ayumi, Kuvalekar, Manik, Gee, Adrian P., Naik, Swati, Martinez, Caridad A., Leung, Kathryn, Sasa, Ghadir, Lulla, Premal, Krance, Robert A., Carrum, George, Ramos, Carlos A., Vera, Juan F., Grilley, Bambi J., Brenner, Malcolm K., Rooney, Cliona M., Heslop, Helen E., Leen, Ann M., and Omer, Bilal

Abstract

Viral infections remain a significant cause of morbidity and mortality after allogeneic stem cell transplantation (HSCT). We now report on the outcomes of 67 patients infused with either donor-derived (n=21) or third party “off the shelf” (n=46) virus-specific T cells (VSTs) with activity against 5 common post-transplant viruses (EBV, CMV, Adv, BK, HHV6).

Published
2017
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