Acquired Immunodeficiency SyndromePhase 2NCT02479698

Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus

A Phase 2 study testing Allogeneic BK-specific Cytotoxic T-lymphocytes and Laboratory Biomarker Analysis in people with Acquired Immunodeficiency Syndrome and BK Virus Infection, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Acquired Immunodeficiency Syndrome, BK Virus Infection, Human Immunodeficiency Virus
What is being tested?: Allogeneic BK-specific Cytotoxic T-lymphocytes and Laboratory Biomarker Analysis
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 23 Jul 2015to 31 Jul 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients ≥ 2 years.
English and non-English speaking patients are eligible.
Immunocompromised patients including but not limited to those with any type of malignancy, HIV/AIDS, or history of solid organ transplant
Non-immunocompromised patients with PML/JC virus encephalitis
Microscopic or greater hematuria urine or blood PCR positive for BK virus
Biopsy proven BK nephritis and urine or blood PCR positive for BK virus disease and/or polyomavirus.

Show all 19Show fewer

Definite or probable PML/JC viral encephalitis (see Appendix C)
JC end-organ disease
Receiving > 6 mg / day of prednisone or equivalent at the time of enrollment.
Patients with BK virus hemorrhagic cystitis, who are receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion.
Patients with JCV encephalitis / PML may be receiving pembrolizumab.
Written informed consent and/or signed assent from patient, parent or guardian.
Patients with cognitive impairments are eligible.
A negative pregnancy test in female patients of childbearing potential. Childbearing potential is defined as pre-menopausal, post-menopausal for < 1 year, and not having undergone surgical sterilization.
Women of childbearing potential must be willing to use an effective contraceptive measure while on study.
Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI.
Patients with bacterial infections must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.
Patients with fungal infections patients must be receiving definitive systemic anti fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.
Patients may be re-enrolled in the protocol if the BK or JC virus infection recurs, so long as they meet all the other eligibility criteria at the time of re-enrollment.

Who cannot join

Patients receiving > 6 mg / day of prednisone or equivalent at time of
Patients who have received ATG within 14 days of enrollment
Patients who have received donor lymphocyte infusion (DLI) within 28 days of enrollment.
Patients who have received alemtuzumab within 28 days of enrollment.
Patients with other uncontrolled infections (including HIV/AIDS). Uncontrolled infection is defined as the presence of hemodynamic instability attributable to sepsis, or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as uncontrolled infection.
Patients with active acute GVHD grades II-IV.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

George Chen, MD contact

713-792-3630

GLChen1@mdanderson.org

United States1 site, 1 recruiting

M D Anderson Cancer Center
Houston, Texas, 77030
George Chen, MD, 713-792-3630, GLChen1@mdanderson.org
George Chen
Recruiting

Other trials in United States

About this study

Official title: Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection

Read the detailed description

PRIMARY OBJECTIVE:

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 HIV/AIDs, and/or history of solid organ transplant with BK and JC infections.,

SECONDARY OBJECTIVE:

To assess the persistence of the administered BK-CTLs generated by ex vivo expansion in immunocompromised patients, patients with any type of malignancies, or HIV/AIDs, and/or history of solid organ transplant with BK and JC infections.

Conditions: Acquired Immunodeficiency Syndrome, BK Virus Infection, Human Immunodeficiency Virus, JC Virus Infection, Malignant Neoplasm, Merkel Cell Carcinoma
Being tested: Allogeneic BK-specific Cytotoxic T-lymphocytes, Laboratory Biomarker Analysis
Medical subject headings: Acquired Immunodeficiency Syndrome, Neoplasms, Carcinoma, Merkel Cell, Encephalitis, Viral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Allogeneic BK-specific Cytotoxic T-lymphocytesBiological
Also called Allogeneic BK-CTLs, Allogeneic BK-specific CTLs
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies

Study groups in NCT02479698
Study group	Role	What they receive
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. Receives: Biological: Allogeneic BK-specific Cytotoxic T-lymphocytes; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Within 28 days of the last dose of cytotoxic T lymphocytes (CTLs)
Incidence of adverse events
Will be continuously monitored.
Measured: Up to day 100

Secondary outcomes (2)

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.
Measured: Up to 12 months
Glomerular filtration rate
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.
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 201531 Jul 2027

First posted24 Jun 2015 (estimated)
Study start23 Jul 2015
Primary completion31 Jul 2027 (estimated)
Study completion31 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02479698
Sponsor's protocol ID: 2014-0279
Other IDs: NCI-2015-01264, 2014-0279
Status last verified: Aug 2026
First submitted: 19 Jun 2015
Last updated: 4 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 42402341
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.
PubMed 33929874
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.
PubMed 30304652

Interested in taking part?

George Chen, MD

713-792-3630

GLChen1@mdanderson.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection
ClinicalTrials.gov ID: NCT02479698
Acronym / sponsor ID: 2014-0279
Conditions: Acquired Immunodeficiency Syndrome, BK Virus Infection, Human Immunodeficiency Virus, JC Virus Infection, Malignant Neoplasm, Merkel Cell Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 23 Jul 2015 (actual)
Primary completion: 31 Jul 2027 (estimated)
Study completion: 31 Jul 2027 (estimated)
First posted: 24 Jun 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

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 HIV/AIDs, and/or history of solid organ transplant with BK and JC infections.,

SECONDARY OBJECTIVE:

To assess the persistence of the administered BK-CTLs generated by ex vivo expansion in immunocompromised patients, patients with any type of malignancies, or HIV/AIDs, and/or history of solid organ transplant with BK and JC infections.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (BK-specific cytotoxic T lymphocytes)	Experimental	Biological: Allogeneic BK-specific Cytotoxic T-lymphocytes, Other: Laboratory Biomarker AnalysisPatients 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (19 listed)

Patients ≥ 2 years.
English and non-English speaking patients are eligible.
Immunocompromised patients including but not limited to those with any type of malignancy, HIV/AIDS, or history of solid organ transplant
Non-immunocompromised patients with PML/JC virus encephalitis
Microscopic or greater hematuria urine or blood PCR positive for BK virus

Key exclusion criteria (6 listed)

Patients receiving > 6 mg / day of prednisone or equivalent at time of
Patients who have received ATG within 14 days of enrollment
Patients who have received donor lymphocyte infusion (DLI) within 28 days of enrollment.
Patients who have received alemtuzumab within 28 days of enrollment.
Patients with other uncontrolled infections (including HIV/AIDS). Uncontrolled infection is defined as the presence of hemodynamic instability attributable to sepsis, or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as uncontrolled infection.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Allogeneic BK-specific Cytotoxic T-lymphocytesAlso: Allogeneic BK-CTLs, Allogeneic BK-specific CTLsGiven IV	Biological	Treatment (BK-specific cytotoxic T lymphocytes)
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (BK-specific cytotoxic T lymphocytes)

Primary outcome

Response, defined as response (R) = (best response [R1] or second best response [R2])
Time frame: Up to 56 days
The method of Thall et al will be used to monitor the probabilities of response.
Incidence of acute graft-versus-host disease (GVHD)
Time frame: Within 28 days of the last dose of cytotoxic T lymphocytes (CTLs)
The method of Thall et al will be used to monitor the probabilities of grade 3 or 4 GVHD.
Incidence of adverse events
Time frame: Up to day 100
Will be continuously monitored.

2 secondary outcomes

Overall survival
Time frame: Up to 12 months
Glomerular filtration rate
Time frame: Up to 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Derived from this study: PubMed 42402341Olson 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.
Derived from this study: PubMed 33929874Olson 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.
Derived from this study: PubMed 30304652Muftuoglu 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.
University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

George Chen, MD contact

713-792-3630

GLChen1@mdanderson.org

George Chen, MD principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact George Chen, MD (713-792-3630, GLChen1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response, defined as response (R) = (best response [R1] or second best response [R2]) (time frame: Up to 56 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02479698, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.