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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01264 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2014-0279 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.
PRIMARY OBJECTIVE:
I. To assess the efficacy, feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched BK specific cytotoxic T lymphocyte (CTL) lines (BK-CTLs) generated by ex vivo expansion to mediate antiviral activity in patients with any type of malignancies, and/or human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDs), and/or history of solid organ transplant with BK and JC infections.
SECONDARY OBJECTIVE:
I. To assess the persistence of the administered BK-CTLs generated by ex vivo expansion in patients with any type of malignancies, and/or HIV/AIDs, and/or history of solid organ transplant with BK and JC infections.
OUTLINE:
Patients receive allogeneic BK-specific cytotoxic T-lymphocytes intravenously (IV) over 30 minutes. Patients achieving partial response, stable disease, or progressive disease are eligible for 7 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy.
After completion of study treatment, patients are followed up periodically for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (BK-specific cytotoxic T lymphocytes) | Experimental | Patients receive allogeneic BK-specific cytotoxic T-lymphocytes IV over 30 minutes. Patients achieving partial response, stable disease, or progressive disease are eligible for 19 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic BK-specific Cytotoxic T-lymphocytes | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response, defined as response (R) = (best response [R1] or second best response [R2]) | The method of Thall et al will be used to monitor the probabilities of response. | Up to 56 days |
| Incidence of acute graft-versus-host disease (GVHD) | The method of Thall et al will be used to monitor the probabilities of grade 3 or 4 GVHD. | Within 28 days of the last dose of cytotoxic T lymphocytes (CTLs) |
| Incidence of adverse events | Will be continuously monitored. | Up to day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Each outcome will be evaluated by tabulation and by fitting a Bayesian statistical regression model for binary outcomes as a function of covar. Unadjusted event time distributions will be estimated using the Kaplan-Meier method. | Up to 12 months |
| Glomerular filtration rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Chen, MD | Contact | 713-792-3630 | GLChen1@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| George Chen, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42402341 | Derived | Olson A, Li Y, Marin D, Thall PF, Bassett RL, Barnett M, Basar R, Banerjee PP, Kleiman TA, Chen M, Rexer J, Wintermark M, Choi J, Learned K, Kaur I, Sylejmani M, Abueg G, Chemaly RF, Mulanovich V, Shrestha R, Uprety N, Castro KM, Daher M, Galvan IM, Washington D, Champlin RE, Shpall EJ, Rezvani K. Treatment of Progressive Multifocal Leukoencephalopathy with Third-Party Allogeneic BK Virus T Cells. Clin Infect Dis. 2026 Jul 6:ciag404. doi: 10.1093/cid/ciag404. Online ahead of print. | |
| 33929874 |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
Each outcome will be evaluated by tabulation and by fitting a Bayesian statistical regression model for binary outcomes as a function of covar. Unadjusted event time distributions will be estimated using the Kaplan-Meier method. |
| Up to 12 months |
| Derived |
| Olson A, Lin R, Marin D, Rafei H, Bdaiwi MH, Thall PF, Basar R, Abudayyeh A, Banerjee P, Aung FM, Kaur I, Abueg G, Rao S, Chemaly R, Mulanovich V, Al-Atrash G, Alousi AM, Andersson BS, Anderlini P, Bashir Q, Castro KM, Daher M, Galvan IM, Hosing C, Im JS, Jones RB, Kebriaei P, Khouri I, Mehta R, Molldrem J, Nieto Y, Oran B, Popat U, Qazilbash M, Rondon G, Saini N, Spencer B, Srour S, Washington D, Barnett M, Champlin RE, Shpall EJ, Rezvani K. Third-Party BK Virus-Specific Cytotoxic T Lymphocyte Therapy for Hemorrhagic Cystitis Following Allotransplantation. J Clin Oncol. 2021 Aug 20;39(24):2710-2719. doi: 10.1200/JCO.20.02608. Epub 2021 Apr 30. |
| 30304652 | Derived | Muftuoglu M, Olson A, Marin D, Ahmed S, Mulanovich V, Tummala S, Chi TL, Ferrajoli A, Kaur I, Li L, Champlin R, Shpall EJ, Rezvani K. Allogeneic BK Virus-Specific T Cells for Progressive Multifocal Leukoencephalopathy. N Engl J Med. 2018 Oct 11;379(15):1443-1451. doi: 10.1056/NEJMoa1801540. |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D009369 | Neoplasms |
| D015266 | Carcinoma, Merkel Cell |
| D018792 | Encephalitis, Viral |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D000069544 | Infectious Encephalitis |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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