EBVPhase 1NCT01945814
Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL)
A Phase 1 study testing CTL for CMV seropositive donors and CTL for CMV naïve donors in people with EBV and CMV, run by Catherine Bollard at 1 site in United States.
Trial summary
In this study, investigators are trying to see if infusion of T cells (called CTLs) will prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or infection. Patients with blood cell cancer, other blood disease or a genetic disease may receive a stem cell transplant. Read more about this study
- Who is it for?
- Ages 4 weeks to 45 years
- Conditions the study is for
- EBV, CMV, Adenovirus
- What is being tested?
- CTL for CMV seropositive donors and CTL for CMV naïve donors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 16 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 4 weeks to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Recipient Inclusion Criteria at the time of CTL infusion
- Received prior myeoloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or PBSC within 12 months
- Cells administered as;
- Prophylaxis for patients at risk of EBV, CMV, or Adenovirus.
- Treatment of reactivation or infection for EBV, CMV, or Adenovirus.
- Early treatment for single or multiple infections. Multiple infections with one reactivation and one controlled infection are eligible to enroll.
Show all 14Show fewer
- Steroids less than 0.5 mg/kg/day prednisone
- Karnofsky/Lansky score of ≥ 50
- ANC greater than 500/µL.
- Bilirubin <2x, AST <3x, Serum creatinine <2x upper limit of normal, Hgb >8.0
- Pulse oximetry of > 90% on room air
- Available multivirus-specific cytotoxic T lymphocytes
- Negative pregnancy test (if female of childbearing potential)
- Patient or parent/guardian capable of providing informed consent.
Who cannot join
- Recipient Exclusion criteria at the time of CTL infusion
- Patients with other uncontrolled infections (see 2.3.2 for definitions)
- Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal antibodies in the last 28 days
- Received donor lymphocyte infusion in last 28 days
- Evidence of GVHD > grade 2
- Active and uncontrolled relapse of malignancy
Show all 9Show fewer
- Pregnant or lactating
- Unable to wean steroids to ≤0.5 mg/kg/day prednisone.
- Patients with Grade 3 hyperbilirubinemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL) Targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton)
In this study, investigators are trying to see if infusion of T cells (called CTLs) will prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or infection.
Patients with blood cell cancer, other blood disease or a genetic disease may receive a stem cell transplant. After receiving transplant, they are at risk of infections until a new immune system to fight infections grows from the cord blood cells. In this study, investigators are trying to give special cells called T cells. These cells will try to fight viruses that can cause infection.
Read more
Investigators will test to see if blood cells from donor that have been grown in a special way, can prevent patients from getting an infection. EBV, AdV and CMV are viruses that can cause serious life-threatening infections in patients who have weak immune systems after transplant.
T lymphocytes can kill viral cells but normally there are not enough of them to kill all the virus infected cells after transplant. Some researcher have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person during a viral infection after a bone marrow transplant. Some of these studies have shown a positive therapeutic effect in patients receiving the CTLs after a viral infection in the post-transplant period.
Investigators will grow these cells from donor in the laboratory in a way that will train them to recognize and remove viruses when the T cells are given after a transplant. Since most donors have previously been infected with EBV, CMV, and adenovirus, investigators are able to use their T cells that remember these viruses to grow the CTLs. However, they now also have a new way of growing CTLs from donors who have not been infected with CMV.
Read the detailed description
Viral infections are normally controlled by T-cell immunity and so are an important cause of morbidity and mortality during the period of immune recovery after hematopoietic stem cell transplantation (HSCT).1 Risk for infection is impacted by the degree of tissue mismatch between donor and recipient and the immune status of the donor, including the degree and length of immunosuppression following transplantation. Reactivation of latent viruses such as cytomegalovirus (CMV) and Epstein-Barr virus (EBV) are common and often cause symptomatic disease. Respiratory viruses such as adenovirus also frequently cause infection. Antiviral pharmacologic agents are only effective against some of these viruses; their use is costly, and associated with significant toxicities and the outgrowth of drug-resistant mutants. As delay in recovery of virus-specific cellular immune response is clearly associated with viral reactivation and disease in these patients, cellular immunotherapy to restore viral-specific immunity is an attractive option that has already been successfully used to target some of these viruses.
Multivirus-Specific T Cells
To broaden the specificity of single CTL lines to include the three most common viral pathogens of stem cell recipients, investigators reactivated CMV and adenovirus-specific T cells by using mononuclear cells transduced with a recombinant adenoviral vector encoding the CMV antigen pp65 (Ad5f35CMVpp65). Subsequent stimulations with EBV-LCL transduced with the same vector both reactivated EBV-specific T cells and maintained the expansion of the activated adenovirus and CMV-specific T cells. This method reliably produced CTLs with cytotoxic function specific for all three viruses, which investigators infused into 14 stem cell recipients in a Phase I prophylaxis study. They observed recovery of immunity to CMV and EBV in all patients but an increase in adenovirus-specific T cells was only seen in patients who had evidence of adenovirus infection pre-infusion. A follow-up study in which the frequency of adenovirus-specific T cells was increased in the infused CTLs produced similar results, thus highlighting the importance of endogenous antigen to promote the expansion of infused T cells in vivo. Nevertheless, all patients in both clinical trials with pre-infusion CMV, adenovirus or EBV infection or reactivation were able to clear the infection, including one patient with severe adenoviral pneumonia requiring ventilatory support. CTLs recognizing multiple antigens can therefore produce clinically relevant effects against all three viruses.
CTLs for HSCT patients with virus naïve donors
All the donor specific T cell strategies discussed so far have utilized products derived from donors who are seropositive for the virus of interest. With the increasing use of cord blood (CB) grafts there are appreciable numbers of patients who are recipients of virus naïve donor grafts. CMV reactivation usually occurs from endogenous virus and seropositive recipients with seronegative donors remain the highest risk group for developing CMV. The development of multivirus specific T cells from recipients of cord blood grafts requires the priming of naïve T-cells rather than the simple expansion of pre-existing memory T-cells from seropositive donors. Using a protocol stimulating CB-derived T-cells with autologous CB-derived dendritic cells and EBV-LCL transduced with the Ad5f35CMVpp65 vector in the presence of IL-7, 12 and 15, multivirus specific T cells can be primed in vitro from the 20% fraction of a cord blood unit. So far, eight patients have received CTL as prophylaxis or treatment after CBT without toxicity. No infusion-related toxicities/GvHD have been observed and despite receiving only 80% of the CB unit, all patients engrafted neutrophils within 30 days. Early evidence of efficacy has also been demonstrated with clearance of EBV, CMV and adenovirus in two patients and decreasing EBV viral load in a third with the other 5 patients remaining virus free. Therefore, these results suggest that transfer of naïve T cell (CB)-derived virus specific T cells to patients after CBT may be safe and facilitate long term reconstitution of virus-specific T-cells in vivo.
- Conditions
- EBV, CMV, Adenovirus
- Being tested
- CTL for CMV seropositive donors, CTL for CMV naïve donors
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTL for CMV seropositive donorsDrug
CTL for CMV seropositive donors-Allogeneic Multivirus Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV seropositive donors dose is depending on the toxicity outcome, the maximum sample size for the this phase I portion of the trial is 14. Upon the completion of mCTL safety evaluation, additional 7 patients will be accrued at the MTD level to evaluate its antiviral activity.
CTL for CMV naïve donorsDrug
CTL for CMV naïve donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV naïve donors dose is depending on the toxicity outcome, the maximum sample size for the this phase I portion of the trial is 14. Upon the completion of mCTL safety evaluation, additional 7 patients will be accrued at the MTD level to evaluate its antiviral activity.
| Study group | Role | What they receive |
|---|---|---|
| CTL for CMV seropositive donors | Experimental | CTL for CMV seropositive donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV seropositive donors- three different dose levels are selected, starting with 5 x 106 (a T cell number more than an order of magnitude lower than that administered at the time of an unmanipulated marrow infusion), followed by 1 x 107 and a final dose 2 x 107 mCTLs/m2. Two additional doses (at the same level)will be administered 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL. Receives: Drug: CTL for CMV seropositive donors |
| CTL for CMV naïve donors | Experimental | CTL for CMV naïve donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton)for CMV naïve donors-each group will undergo an identical dose escalation. Three different dose levels are selected, starting with 5 x 106 (a T cell number more than an order of magnitude lower than that administered at the time of an unmanipulated marrow infusion), followed by 1 x 107 and a final dose 2 x 107 mCTLs/m2. Two additional doses (at the same level)will be administered 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL. Receives: Drug: CTL for CMV naïve donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessments of patients with adverse events after mukti-virus specific CTL infusion.
The primary endpoint for this phase I trial are feasibility and safety. Safety of administration of CTLs is 45 days. The safety endpoint will be defined as acute GvHD grades III-IV within 45 days of the last dose of CTLs or grades 3-5 infusion-related adverse events within 45 days of the last CTL dose or grades 4-5 non-hematological adverse events within 45 days of the last CTL dose and that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities.
Measured: 45 days
Secondary outcomes (1)
Assessments of viral load response to the CTL infusion
Assessment of the effect of the CTL infusion on viral load, reconstitution of antiviral immunity post-infusion, and clinical response.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startFeb 2014
- Primary completion31 Oct 2017
- Study completion16 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EBVStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Bollard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Catherine Bollard, Children's National Research Institute
- Investigators
- Catherine Bollard, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945814
- Sponsor's protocol ID
- MUSTAT
- Status last verified
- Jul 2025
- First submitted
- 12 Sep 2013
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Publications
Keller MD, Darko S, Lang H, Ransier A, Lazarski CA, Wang Y, Hanley PJ, Davila BJ, Heimall JR, Ambinder RF, Barrett AJ, Rooney CM, Heslop HE, Douek DC, Bollard CM. T-cell receptor sequencing demonstrates persistence of virus-specific T cells after antiviral immunotherapy. Br J Haematol. 2019 Oct;187(2):206-218. doi: 10.1111/bjh.16053. Epub 2019 Jun 20.
PubMed 31219185
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL) Targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton)
- ClinicalTrials.gov ID
- NCT01945814
- Acronym / sponsor ID
- MUSTAT
- Conditions
- EBV, CMV, Adenovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Catherine BollardUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 19 Sep 2013 (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.
In this study, investigators are trying to see if infusion of T cells (called CTLs) will prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or infection.
Patients with blood cell cancer, other blood disease or a genetic disease may receive a stem cell transplant. After receiving transplant, they are at risk of infections until a new immune system to fight infections grows from the cord blood cells. In this study, investigators are trying to give special cells called T cells. These cells will try to fight viruses that can cause infection.
Investigators will test to see if blood cells from donor that have been grown in a special way, can prevent patients from getting an infection. EBV, AdV and CMV are viruses that can cause serious life-threatening infections in patients who have weak immune systems after transplant.
T lymphocytes can kill viral cells but normally there are not enough of them to kill all the virus infected cells after transplant. Some researcher have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person during a viral infection after a bone marrow transplant. Some of these studies have shown a positive therapeutic effect in patients receiving the CTLs after a viral infection in the post-transplant period.
Investigators will grow these cells from donor in the laboratory in a way that will train them to recognize and remove viruses when the T cells are given after a transplant. Since most donors have previously been infected with EBV, CMV, and adenovirus, investigators are able to use their T cells that remember these viruses to grow the CTLs. However, they now also have a new way of growing CTLs from donors who have not been infected with CMV.
Detailed description
Viral infections are normally controlled by T-cell immunity and so are an important cause of morbidity and mortality during the period of immune recovery after hematopoietic stem cell transplantation (HSCT).1 Risk for infection is impacted by the degree of tissue mismatch between donor and recipient and the immune status of the donor, including the degree and length of immunosuppression following transplantation. Reactivation of latent viruses such as cytomegalovirus (CMV) and Epstein-Barr virus (EBV) are common and often cause symptomatic disease. Respiratory viruses such as adenovirus also frequently cause infection. Antiviral pharmacologic agents are only effective against some of these viruses; their use is costly, and associated with significant toxicities and the outgrowth of drug-resistant mutants. As delay in recovery of virus-specific cellular immune response is clearly associated with viral reactivation and disease in these patients, cellular immunotherapy to restore viral-specific immunity is an attractive option that has already been successfully used to target some of these viruses.
Multivirus-Specific T Cells
To broaden the specificity of single CTL lines to include the three most common viral pathogens of stem cell recipients, investigators reactivated CMV and adenovirus-specific T cells by using mononuclear cells transduced with a recombinant adenoviral vector encoding the CMV antigen pp65 (Ad5f35CMVpp65). Subsequent stimulations with EBV-LCL transduced with the same vector both reactivated EBV-specific T cells and maintained the expansion of the activated adenovirus and CMV-specific T cells. This method reliably produced CTLs with cytotoxic function specific for all three viruses, which investigators infused into 14 stem cell recipients in a Phase I prophylaxis study. They observed recovery of immunity to CMV and EBV in all patients but an increase in adenovirus-specific T cells was only seen in patients who had evidence of adenovirus infection pre-infusion. A follow-up study in which the frequency of adenovirus-specific T cells was increased in the infused CTLs produced similar results, thus highlighting the importance of endogenous antigen to promote the expansion of infused T cells in vivo. Nevertheless, all patients in both clinical trials with pre-infusion CMV, adenovirus or EBV infection or reactivation were able to clear the infection, including one patient with severe adenoviral pneumonia requiring ventilatory support. CTLs recognizing multiple antigens can therefore produce clinically relevant effects against all three viruses.
CTLs for HSCT patients with virus naïve donors
All the donor specific T cell strategies discussed so far have utilized products derived from donors who are seropositive for the virus of interest. With the increasing use of cord blood (CB) grafts there are appreciable numbers of patients who are recipients of virus naïve donor grafts. CMV reactivation usually occurs from endogenous virus and seropositive recipients with seronegative donors remain the highest risk group for developing CMV. The development of multivirus specific T cells from recipients of cord blood grafts requires the priming of naïve T-cells rather than the simple expansion of pre-existing memory T-cells from seropositive donors. Using a protocol stimulating CB-derived T-cells with autologous CB-derived dendritic cells and EBV-LCL transduced with the Ad5f35CMVpp65 vector in the presence of IL-7, 12 and 15, multivirus specific T cells can be primed in vitro from the 20% fraction of a cord blood unit. So far, eight patients have received CTL as prophylaxis or treatment after CBT without toxicity. No infusion-related toxicities/GvHD have been observed and despite receiving only 80% of the CB unit, all patients engrafted neutrophils within 30 days. Early evidence of efficacy has also been demonstrated with clearance of EBV, CMV and adenovirus in two patients and decreasing EBV viral load in a third with the other 5 patients remaining virus free. Therefore, these results suggest that transfer of naïve T cell (CB)-derived virus specific T cells to patients after CBT may be safe and facilitate long term reconstitution of virus-specific T-cells in vivo.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTL for CMV seropositive donors | Experimental | Drug: CTL for CMV seropositive donorsCTL for CMV seropositive donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV seropositive donors- three different dose levels are selected, starting with 5 x 106 (a T cell number more than an order of magnitude lower than that administered at the time of an unmanipulated marrow infusion), followed by 1 x 107 and a final dose 2 x 107 mCTLs/m2. Two additional doses (at the same level)will be administered 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL. |
| CTL for CMV naïve donors | Experimental | Drug: CTL for CMV naïve donorsCTL for CMV naïve donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton)for CMV naïve donors-each group will undergo an identical dose escalation. Three different dose levels are selected, starting with 5 x 106 (a T cell number more than an order of magnitude lower than that administered at the time of an unmanipulated marrow infusion), followed by 1 x 107 and a final dose 2 x 107 mCTLs/m2. Two additional doses (at the same level)will be administered 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL. |
Who may qualify
- Ages
- 4 weeks to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Recipient Inclusion Criteria at the time of CTL infusion
Key exclusion criteria (9 listed)
- Recipient Exclusion criteria at the time of CTL infusion
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 |
|---|---|---|
| CTL for CMV seropositive donorsCTL for CMV seropositive donors-Allogeneic Multivirus Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV seropositive donors dose is depending on the toxicity outcome, the maximum sample size for the this phase I portion of the trial is 14. Upon the completion of mCTL safety evaluation, additional 7 patients will be accrued at the MTD level to evaluate its antiviral activity. | Drug | CTL for CMV seropositive donors |
| CTL for CMV naïve donorsCTL for CMV naïve donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV naïve donors dose is depending on the toxicity outcome, the maximum sample size for the this phase I portion of the trial is 14. Upon the completion of mCTL safety evaluation, additional 7 patients will be accrued at the MTD level to evaluate its antiviral activity. | Drug | CTL for CMV naïve donors |
Primary outcome
Assessments of patients with adverse events after mukti-virus specific CTL infusion.
Time frame: 45 days
The primary endpoint for this phase I trial are feasibility and safety. Safety of administration of CTLs is 45 days. The safety endpoint will be defined as acute GvHD grades III-IV within 45 days of the last dose of CTLs or grades 3-5 infusion-related adverse events within 45 days of the last CTL dose or grades 4-5 non-hematological adverse events within 45 days of the last CTL dose and that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities.
1 secondary outcome
Assessments of viral load response to the CTL infusion
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Derived from this study: PubMed 31219185Keller MD, Darko S, Lang H, Ransier A, Lazarski CA, Wang Y, Hanley PJ, Davila BJ, Heimall JR, Ambinder RF, Barrett AJ, Rooney CM, Heslop HE, Douek DC, Bollard CM. T-cell receptor sequencing demonstrates persistence of virus-specific T cells after antiviral immunotherapy. Br J Haematol. 2019 Oct;187(2):206-218. doi: 10.1111/bjh.16053. Epub 2019 Jun 20.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Catherine Bollard, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTL for CMV seropositive donors and CTL for CMV naïve donors in people with EBV and CMV, run by Catherine Bollard at 1 site in United States.
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 14 inclusion and 9 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: finished, as of the sponsor's last update on 3 Jul 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessments of patients with adverse events after mukti-virus specific CTL infusion. (time frame: 45 days). 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 NCT01945814, which also lists 1 linked publication.
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 3 Jul 2025.