CMVPhase 1NCT01923766
Cytotoxic T Cells to Prevent Virus Infections
A Phase 1 study testing Cytotoxic T lymphocytes (CTLs). in people with CMV and EBV, run by Children's National Research Institute at 2 sites in United States.
Trial summary
In this study, investigators are trying to see if infusion of "m-CTLs" will prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or infection after cord blood transplant. Read more about this study
- Who is it for?
- Ages 4 weeks and older
- Conditions the study is for
- CMV, EBV, Adenovirus Infections
- What is being tested?
- Cytotoxic T lymphocytes (CTLs).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2013to 25 Mar 2020
- 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with malignant or nonmalignant diseases who are candidates for transplant.
- Patients must have a CB unit (or units) matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens.
- Recipients of at least one unmanipulated cord blood unit fractionated into 2 fractions (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with CMV/Adenoviral disease or reactivation.
- Lansky/Karnofsky scores >60
- Absolute neutrophil count (ANC) greater than 500/ul.
- No evidence of GVHD > Grade II at time of enrollment.
Show all 12Show fewer
- Life expectancy > 30 days
- Absence of severe renal disease (Creatinine > x 3 normal for age)
- Absence of severe hepatic disease. Direct bilirubin must be < 3 mg/dl and AST < 5x upper limit of normal.
- Patient must be at least 30 days post transplant to be eligible to receive CTL
- Written informed consent and/or signed assent line from patient, parent or guardian.
- Patient not on Fi02 of >60%
Who cannot join
- Pregnant or lactating
- Patients with active central nervous system disease
- Patients with Karnofsky performance status <70%
- Patients with grade 3 or 4 or primary myelofibrosis
- Patients with suitable related donors
- Pregnant or lactating
Show all 9Show fewer
- Unable to wean steroids to ≤0.5 mg/kg/day prednisone.
- Patients with other uncontrolled infections (except CMV and/or adenovirus and/or EBVemia).
- Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Amanda Olson, MD
Houston, Texas
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Adoptive Transfer of Cord Blood T Cells to Prevent and Treat CMV, EBV and Adenovirus Infections After Transplantation
In this study, investigators are trying to see if infusion of "m-CTLs" will prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or infection after cord blood transplant.
Patients with blood cell cancer, other blood disease or a genetic disease may receive a cord blood transplant (UCBT) from an unrelated donor. After receiving a cord blood 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 from the cord blood 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 (specially trained T cells) after a viral infection in the post-transplant period. In this study we are trying to prevent or treat viral infections by given the CTLs soon after getting the umbilical cord blood transplant.
With this study, investigators want to see if they can use a kind of white blood cell called T cells to prevent or treat AdV, EBV and CMV infection. Investigators will grow these T cells from the cord blood before transplant. These cells have been trained to attack adenovirus/EBV/CMV- infected cells and are called multivirus-specific cytotoxic (killer) T-cells or "m-CTL." Investigators would plan to give patients one dose of m-CTL any time from 30 to 364 days after your transplant. They have used T cells made in this way from the blood of donors to prevent infections in patients who are getting a bone marrow or blood stem cell transplant but this will be the first time investigators make them from cord blood.
Read the detailed description
Umbilical cord blood (UCB) is a readily available alternative source of Hemotopoietic Stem Cells (HSCs) that is capable of reconstituting hematopoiesis after myeloablative therapy. More than 280,000 UCB units have been banked world-wide and more than 13,000 unrelated donor UCB transplantations have been performed.
UCB transplants offer several advantages over adult bone marrow or peripheral blood stem cell transplants, including: 1) rapid availability, 2) absence of donor risk, 3) low risk of transmissible infectious diseases, 4) low risk of acute Graft versus Host Disease (GvHD) in the setting of Human Leukocye Antigen (HLA) mismatch (as compared to recipients of unrelated donor marrow and peripheral blood). UCB is particularly beneficial for patients of ethnic and racial minority descent for whom adult marrow and blood donors often cannot be identified.
In a larger series the neutrophil engraftment has been reported as high as 92%. The incidence of acute GvHD reported in larger series ranges from 33-44% to 11-22% for grades II-IV and III-IV acute GvHD, respectively. The incidence of chronic GvHD ranges from 0-25%. These results are particularly notable since most UCB donor-recipient pairs are 1-2 HLA antigen mismatched. However, infection related TRMs are still of concern after UCBT. The rate of hemopoietic recovery is slower after UCBT; therefore infectious complications including viral infections occur frequently.
Multi virus Specific T cells from Cord Blood could be applied with comparable success to recipients of CB transplants; however, certain obstacles to the extension of this approach must be circumvented. These include: (i) the limited numbers of CB T-cells available for manipulation and (ii) the naivety of CB T-cells. Hence, the development of virus-protective T-cell therapy for patients undergoing CBT requires the priming and extensive expansion of naïve T-cells rather than the more limited and simple direct expansion of pre-existing virus-specific memory T-cell populations from virus-experienced donors. Further, CB T-cells have lower cytotoxic activity and higher activation-induced cell death than peripheral blood T-cells. These limitations have prevented the production of virus-specific cord blood-derived CTL in sufficient numbers for clinical use. Because of these challenges, only a few reports document the generation of antigen-specific T cells from CB. Sun et al first reported the ability to generate EBV-specific CD4+ T cells using EBV-transformed B-cells, or lymphoblastoid cell lines (LCL). Park et al then reported the ability to generate CMV-pp65-specific T cells from cord blood by using CMV-immune complex-loaded DCs, CMV lysate, and IL-12 and IL-7. The study at Baylor College of Medicine (BCM)showed that Ad5f35pp65-transduced CB-derived APC could be used to generate large numbers of autologous T-cells specific for both CMV and Ad, even from the phenotypically naive T-cell subpopulation. Addition of EBV-transformed B-lymphoblastoid cell lines (LCL) to the APCs allowed the Ad/CMV specificity of the CB T-cells to be extended to EBV. In addition, the multivirus-specific T-cells recognized an array of epitopes after only 2 weeks expansion in vivo. We therefore suggest that our ability to generate virus-specific CTL from CB against a plethora of epitopes recognized by both CD4+ and CD8+ T-cells should minimize the risk of viral escape and maximize therapeutic benefit on administration of these cells to cord blood recipients at risk of severe viral disease. A clinical trial using CB-derived multi-virus specific T cells for the prevention and treatment of viral infection after CBT was started at BCM. (Clinical Trial #: NCT01017705).
- Conditions
- CMV, EBV, Adenovirus Infections
- Being tested
- Cytotoxic T lymphocytes (CTLs).
- Keywords
- Transplantation
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytotoxic T lymphocytes (CTLs).Drug
This Phase I dose-escalation trial is designed to evaluate the safety of donor-derived cytotoxic T lymphocytes (CTLs). Dose escalation is guided by the modified continual reassessment method (mCRM) in order to determine the maximum tolerated dose (MTD). For each group, MTD is defined as the dose at which the probability of DLT is at most 21%. Four dose levels are being evaluated namely, 5x106 cells/m2, 1.0x107 cells/m2, 1.5x107 cells/m2 and 2.5x107 cells/m2 with prior probabilities of toxicity estimated at 5%, 7.1%, 10% and 21%, respectively.
Two patients are allocated in each cohort and are followed for 30 days post IV injection for evaluation of DLTs. The trial continues until a minimum of 12 patients have been treated and stop when the maximum 18 patients have been treated.
| Study group | Role | What they receive |
|---|---|---|
| Cytotoxic T lymphocytes (CTLs) | Experimental | Cytotoxic T lymphocytes (CTLs). CMV/AdV /EBV specific T cells will be given by slow intravenous injection over 1-2 minutes. Four dose levels will be explored. The lowest dose level will be 5x106cells/m2 and the highest will be 2.5x107/m2. During the dose escalation phase two to six patients will be entered at each dose level (depending on toxicity). If there are no toxicities and immunological efficacy is not seen at any dose, then the doses will be further escalated after additional local and federal approval. Receives: Drug: Cytotoxic T lymphocytes (CTLs). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of administration of CTLs
The primary endpoint is to assess the safety of administration of CTLs at 45 days post-infusion. The safety endpoint will be defined as acute GvHD grades III-IV or grade 3 or higher toxicity. Other toxicities to consider include GI , renal , hemorrhagic , cardiovascular, neurologic toxicity, coagulation, vascular and pulmonary toxicity.
For the trial, two patients are allocated in each cohort and are followed for 45 days post IV injection of virus-specific T-cells for evaluation of DLTs. A maximum 18 patients will be accrued into each group. The final maximum tolerated dose (MTD) will be the dose with probability closest to the target toxicity rate at these termination points. The trial continues until a minimum of 12 patients have been treated. The trial will stop when the maximum 18 patients have been treated, or when six patients have been treated at the current MTD. We therefore expect to enroll between 12-18 patients into this trial.
Measured: At 45 days post-infusion
Secondary outcomes (1)
Viral load
Viral load will be monitored using PCR amplification. AdV surveillance cultures, or PCR studies in patients with positive AdV pre CTL will be taken before infusion and then weekly for 60 days.
Patients will be monitored using ELISPOT assays or tetramer assays with appropriate viral specific peptide mixtures if sufficient cell numbers and appropriate reagents are available.
Measured: Viral load will be monitored before infusion and after infusion weekly for a total of 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startSep 2013
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMVStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Catherine Bollard, Children's National Research Institute
- Investigators
- Catherine M Bollard, M.D, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923766
- Sponsor's protocol ID
- ACTCAT2
- Status last verified
- Jul 2020
- First submitted
- 8 Aug 2013
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoptive Transfer of Cord Blood T Cells to Prevent and Treat CMV, EBV and Adenovirus Infections After Transplantation
- ClinicalTrials.gov ID
- NCT01923766
- Acronym / sponsor ID
- ACTCAT2
- Conditions
- CMV, EBV, Adenovirus Infections
- Keywords
- Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Sep 2013
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 16 Aug 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 "m-CTLs" will prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or infection after cord blood transplant.
Patients with blood cell cancer, other blood disease or a genetic disease may receive a cord blood transplant (UCBT) from an unrelated donor. After receiving a cord blood 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 from the cord blood 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 (specially trained T cells) after a viral infection in the post-transplant period. In this study we are trying to prevent or treat viral infections by given the CTLs soon after getting the umbilical cord blood transplant.
With this study, investigators want to see if they can use a kind of white blood cell called T cells to prevent or treat AdV, EBV and CMV infection. Investigators will grow these T cells from the cord blood before transplant. These cells have been trained to attack adenovirus/EBV/CMV- infected cells and are called multivirus-specific cytotoxic (killer) T-cells or "m-CTL." Investigators would plan to give patients one dose of m-CTL any time from 30 to 364 days after your transplant. They have used T cells made in this way from the blood of donors to prevent infections in patients who are getting a bone marrow or blood stem cell transplant but this will be the first time investigators make them from cord blood.
Detailed description
Umbilical cord blood (UCB) is a readily available alternative source of Hemotopoietic Stem Cells (HSCs) that is capable of reconstituting hematopoiesis after myeloablative therapy. More than 280,000 UCB units have been banked world-wide and more than 13,000 unrelated donor UCB transplantations have been performed.
UCB transplants offer several advantages over adult bone marrow or peripheral blood stem cell transplants, including: 1) rapid availability, 2) absence of donor risk, 3) low risk of transmissible infectious diseases, 4) low risk of acute Graft versus Host Disease (GvHD) in the setting of Human Leukocye Antigen (HLA) mismatch (as compared to recipients of unrelated donor marrow and peripheral blood). UCB is particularly beneficial for patients of ethnic and racial minority descent for whom adult marrow and blood donors often cannot be identified.
In a larger series the neutrophil engraftment has been reported as high as 92%. The incidence of acute GvHD reported in larger series ranges from 33-44% to 11-22% for grades II-IV and III-IV acute GvHD, respectively. The incidence of chronic GvHD ranges from 0-25%. These results are particularly notable since most UCB donor-recipient pairs are 1-2 HLA antigen mismatched. However, infection related TRMs are still of concern after UCBT. The rate of hemopoietic recovery is slower after UCBT; therefore infectious complications including viral infections occur frequently.
Multi virus Specific T cells from Cord Blood could be applied with comparable success to recipients of CB transplants; however, certain obstacles to the extension of this approach must be circumvented. These include: (i) the limited numbers of CB T-cells available for manipulation and (ii) the naivety of CB T-cells. Hence, the development of virus-protective T-cell therapy for patients undergoing CBT requires the priming and extensive expansion of naïve T-cells rather than the more limited and simple direct expansion of pre-existing virus-specific memory T-cell populations from virus-experienced donors. Further, CB T-cells have lower cytotoxic activity and higher activation-induced cell death than peripheral blood T-cells. These limitations have prevented the production of virus-specific cord blood-derived CTL in sufficient numbers for clinical use. Because of these challenges, only a few reports document the generation of antigen-specific T cells from CB. Sun et al first reported the ability to generate EBV-specific CD4+ T cells using EBV-transformed B-cells, or lymphoblastoid cell lines (LCL). Park et al then reported the ability to generate CMV-pp65-specific T cells from cord blood by using CMV-immune complex-loaded DCs, CMV lysate, and IL-12 and IL-7. The study at Baylor College of Medicine (BCM)showed that Ad5f35pp65-transduced CB-derived APC could be used to generate large numbers of autologous T-cells specific for both CMV and Ad, even from the phenotypically naive T-cell subpopulation. Addition of EBV-transformed B-lymphoblastoid cell lines (LCL) to the APCs allowed the Ad/CMV specificity of the CB T-cells to be extended to EBV. In addition, the multivirus-specific T-cells recognized an array of epitopes after only 2 weeks expansion in vivo. We therefore suggest that our ability to generate virus-specific CTL from CB against a plethora of epitopes recognized by both CD4+ and CD8+ T-cells should minimize the risk of viral escape and maximize therapeutic benefit on administration of these cells to cord blood recipients at risk of severe viral disease. A clinical trial using CB-derived multi-virus specific T cells for the prevention and treatment of viral infection after CBT was started at BCM. (Clinical Trial #: NCT01017705).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytotoxic T lymphocytes (CTLs) | Experimental | Drug: Cytotoxic T lymphocytes (CTLs).Cytotoxic T lymphocytes (CTLs). CMV/AdV /EBV specific T cells will be given by slow intravenous injection over 1-2 minutes. Four dose levels will be explored. The lowest dose level will be 5x106cells/m2 and the highest will be 2.5x107/m2. During the dose escalation phase two to six patients will be entered at each dose level (depending on toxicity). If there are no toxicities and immunological efficacy is not seen at any dose, then the doses will be further escalated after additional local and federal approval. |
Who may qualify
- Ages
- 4 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patient with malignant or nonmalignant diseases who are candidates for transplant.
- Patients must have a CB unit (or units) matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens.
- Recipients of at least one unmanipulated cord blood unit fractionated into 2 fractions (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with CMV/Adenoviral disease or reactivation.
- Lansky/Karnofsky scores >60
- Absolute neutrophil count (ANC) greater than 500/ul.
Key exclusion criteria (9 listed)
- Pregnant or lactating
- Patients with active central nervous system disease
- Patients with Karnofsky performance status <70%
- Patients with grade 3 or 4 or primary myelofibrosis
- Patients with suitable related donors
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 |
|---|---|---|
| Cytotoxic T lymphocytes (CTLs).This Phase I dose-escalation trial is designed to evaluate the safety of donor-derived cytotoxic T lymphocytes (CTLs). Dose escalation is guided by the modified continual reassessment method (mCRM) in order to determine the maximum tolerated dose (MTD). For each group, MTD is defined as the dose at which the probability of DLT is at most 21%. Four dose levels are being evaluated namely, 5x106 cells/m2, 1.0x107 cells/m2, 1.5x107 cells/m2 and 2.5x107 cells/m2 with prior probabilities of toxicity estimated at 5%, 7.1%, 10% and 21%, respectively. Two patients are allocated in each cohort and are followed for 30 days post IV injection for evaluation of DLTs. The trial continues until a minimum of 12 patients have been treated and stop when the maximum 18 patients have been treated. | Drug | Cytotoxic T lymphocytes (CTLs) |
Primary outcome
To assess the safety of administration of CTLs
Time frame: At 45 days post-infusion
The primary endpoint is to assess the safety of administration of CTLs at 45 days post-infusion. The safety endpoint will be defined as acute GvHD grades III-IV or grade 3 or higher toxicity. Other toxicities to consider include GI , renal , hemorrhagic , cardiovascular, neurologic toxicity, coagulation, vascular and pulmonary toxicity. For the trial, two patients are allocated in each cohort and are followed for 45 days post IV injection of virus-specific T-cells for evaluation of DLTs. A maximum 18 patients will be accrued into each group. The final maximum tolerated dose (MTD) will be the dose with probability closest to the target toxicity rate at these termination points. The trial continues until a minimum of 12 patients have been treated. The trial will stop when the maximum 18 patients have been treated, or when six patients have been treated at the current MTD. We therefore expect to enroll between 12-18 patients into this trial.
1 secondary outcome
Viral load
Time frame: Viral load will be monitored before infusion and after infusion weekly for a total of 60 days.
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 14 Jul 2020.
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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 M Bollard, M.D principal investigator
Children's National Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cytotoxic T lymphocytes (CTLs). in people with CMV and EBV, run by Children's National Research Institute at 2 sites 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 12 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To assess the safety of administration of CTLs (time frame: At 45 days post-infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2020.