Cytomegalovirus InfectionsPhase 1NCT03950414
A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients
A Phase 1 study testing CMV specific T-cells in people with Cytomegalovirus Infections and Solid Organ Transplant, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study measures the tolerability of viral-specific T cells against Cytomegalovirus (CMV) in adult solid organ transplant (SOT) recipients. Participants are expected to be on study for 52 +/- 3 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cytomegalovirus Infections, Solid Organ Transplant
- What is being tested?
- CMV specific T-cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2019to 11 Jul 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age ≥ 18 and ≤75) patients suffering from CMV reactivation/infections following solid organ transplantation (e.g., liver, pancreas, lung, heart, and multi-solid organ)
- CMV reactivation/viremia defined as positive (>250 copies/mL) CMV qPCR(quantitative polymerase chain reaction) AND/OR
- Presence of symptoms secondary to CMV infection or evidence of invasive CMV infection (e.g. pneumonitis, colitis)
- AND ONE OF THE FOLLOWING CRITERIA:
- Absence of an improvement of viral load after ≥ 14 days of standard antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold), or
- New, persistent and/or worsening CMV-related symptoms, signs and/or markers of end organ compromise while on anti-viral therapy with medications such as ganciclovir, acyclovir, valganciclovir, foscarnet, cidofovir, IVIG(Intravenous immunoglobulin), and/or letermovir, or
Show all 10Show fewer
- Have contraindications or experience adverse effects of anti-viral therapy with medications such as ganciclovir, acyclovir, valganciclovir, foscarnet, cidofovir, IVIG, and/or letermovir, or
- Known resistance to the anti-viral medications ganciclovir, foscarnet and/or cidofovir based on molecular testing
- Availability of eligible donor
- Written informed consent given by patient
Who cannot join
- Patient with acute rejection of allograft at time of T-cell transfer
- Patient receiving steroids (>0.5 mg/kg body weight (BW) prednisone equivalent) at the time of T-cell transfer
- Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive monoclonal antibodies within 28 days
- Patients with CMV retinitis
- Concomitant enrollment in another clinical trial interfering with endpoints of this study
- Any medical condition which could compromise participation in the study according to the investigator's assessment
Show all 19Show fewer
- Known HIV infection
- Female patient who is pregnant or breast-feeding, or adult of reproductive potential not willing to use an effective method of birth control during study treatment Note: Women of childbearing potential must have a negative serum pregnancy test at study entry.
- Patients unwilling or unable to comply with the protocol or unable to give informed consent
- Donor Eligibility
- Donor selection priority: The original donor will be the first choice as the source of T cells. If donation from the original organ donor is not possible (e.g., donor is unavailable or ineligible), then an alternative related donor will be selected, with preference for those who have full HLA matching in 6/6 loci over those with partial HLA matching (≥ 2/6 HLA loci). See Appendix 1 for patient and donor screening procedures.
- ≥ 18 years old
- Available and capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood.
- If the original transplant donor is not eligible, then an eligible fully matched or eligible partially matched family member will be used as the donor.
- Related donors must be at least partially HLA compatible, matching with recipient in at least 2/6 HLA loci (HLA-A, HLA-B and HLA-DRB1 will be considered for this).
- Donors must be CMV IgG seropositive.
- Donors must show CMV T-cell activation after incubation with MACS GMP PepTivator Peptide Pools of CMV pp65 before undergoing leukapheresis.
- Donor must meet the criteria for donor selection defined in the UWHC Hematopoietic Stem Cell Transplant Program SOP and FACT standards, which comply with 21 CFR 1271, subpart C.
- Donor must provide written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705
About this study
Official title: A Phase I Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients
This study measures the tolerability of viral-specific T cells against Cytomegalovirus (CMV) in adult solid organ transplant (SOT) recipients. Participants are expected to be on study for 52 +/- 3 weeks.
Read the detailed description
Viral infections, or their reactivation in the immunocompromised host, remain serious complications that adversely affect outcomes of transplantation. These infections may be refractory to pharmacologic treatment and result in increased morbidity and mortality after transplantation. Furthermore, the available pharmacologic therapies can result in severe toxicities.
Once an infection occurs, adequate immune reconstitution is decisive for recovery from viral disease after solid organ transplantation. The present trial will consist of the treatment of solid organ transplant recipients diagnosed with severe CMV infection when standard antiviral therapy is ineffective (disease progression on therapy, decline in viral load less than 10-fold in 2 weeks, known drug resistance), or toxic (end-organ damage), with virus-specific T cells using the CliniMACS® Prodigy System. These are the patients with the greatest unmet need and greatest risk or morbidity and allograft loss due to CMV infection. CMV-specific T cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV-specific T cells have been shown to be safe and efficacious in the treatment of CMV infections.
The primary objective of this Phase I trial is to evaluate the safety and tolerability of CMV-specific T-cell transfer in adult patients suffering from CMV infections following solid organ transplantation using a dose escalation design. The incubation with viral antigens (MACS GMP PepTivator) allows the enrichment of CMV-specific CD4+(Cluster of Differentiation 4) and CD8+(Cluster of Differentiation 8) T cells. Increasing evidence of the safety and efficacy of CMV-specific T-cell is available. Furthermore, the safety and efficacy of the specific manufacturing approach using the fully automated protocol of the ClinMACS® Prodigy for the isolation of CMV-specific T cells against CMV has been described and demonstrated that these cells retain their biological properties.
- Conditions
- Cytomegalovirus Infections, Solid Organ Transplant
- Being tested
- CMV specific T-cells
- Keywords
- T-cell, immunotherapy
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV specific T-cellsBiological
Naturally occurring, allogeneic donor lymphocytes derived from a leukapheresis or a whole blood product, enriched for CMV-specific CD4+ and CD8+ T cells Suspension of CMV-specific T cells in 10 mL of 0.9% NaCl with 2% Human Serum Albumin(HSA) via IV bolus injection
- Low Dose Tier - Viral-Specific T cell infusion 5 x10^3 cells/kg body weight(BW)
- Mid Dose Tier - Viral-Specific T cell infusion 1.25 x10^4 cells/kg BW
- High Dose Tier - Viral-Specific T cell infusion 2.5 x10^4 cells/kg BW Product will be administered fresh intravenously to recipient within four hours of collection.
| Study group | Role | What they receive |
|---|---|---|
| Tier 1 | Experimental | 3 participants enrolled at dose level 5x10^3 cells/kg of CMV viral specific T-cells Receives: Biological: CMV specific T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability:Time of Occurence of Acute GVHD
Time to occurrence of acute GVHD of any grade will be evaluated using the Kaplan-Meier method to assess incidence and severity of acute GVHD from day of T-cell transfer. The first day of GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that GVHD grade. Overall, cumulative incidence curves will be computed along with the 95% confidence intervals until Week 12 after T-cell transfer with death considered as a competing risk.
Measured: up to 15 weeks
Safety and Tolerability: Number of infusion-related adverse events
Incidence of grades 3-5 infusion-related adverse events, grades 4-5 non-hematological adverse events within four weeks of the CMV-VST dose that are not due to the pre-existing infection or original malignancy or pre-existing co-morbidities
Measured: up to 7 weeks
Incidence of acute infusion-related toxicity
Incidence of acute infusion-related toxicity as assessed by maximum toxicity on the day of T-cell transfer, evaluated by measuring vital signs prior to and at different times after the T-cell transfer and monitoring of specific adverse events (chills, nausea, vomiting, diarrhea, abdominal pain, allergic reactions, respiratory dysfunction or headache from T-cell transfer to 4 hours post injection)
Measured: from T-cell transfer to 4 hours post injection, upto 3 weeks
Severity of acute infusion-related toxicity as measured by Cytokine release syndrome (CRS) Grading criteria
Severity of acute infusion-related toxicity will be assessed by CRS grading criteria.
Grade 1 Symptoms are not life threatening and require symptomatic treatment only, (e.g., fever, nausea, fatigue, headache, myalgias, malaise) Grade 2 Symptoms require and respond to moderate intervention Grade 3 Symptoms require and respond to aggressive intervention Grade 4 Life-threatening symptoms Grade 5 Death
Any grade 3 or greater occurrence of CRS will be considered a serious adverse event for this study.
Measured: from T-cell transfer to 4 hours post injection, upto 3 weeks
Number of Participants of Newly Occurring Acute Rejection after T-cell Transfer
Incidence and severity of acute rejection of the organ allograft will in part be measured by number of participants of newly occurring acute rejection after T-cell transfer
Measured: up to 15 weeks
Incidence of de novo Antibodies against Organ Allograft Donor (dnDSA) after T-cell Transfer
Incidence and severity of acute rejection of the organ allograft will in part be measured by presence of de novo antibodies against organ allograft donor (dnDSA) after T-cell transfer
Measured: up to 55 weeks
Incidence of GVHD Grade ≥1
Incidence and severity of Graft-versus-host disease (GVHD) will be measured by occurrence of acute GVHD grade ≥1 or aggravation of pre-existing acute GVHD after T-cell transfer
Measured: up to 15 weeks
Secondary outcomes (10)
Feasibility: Was production of CMV Virus specific T lymphocyte (VST) from donors accomplished?
There is no minimum cell count required for the study as it can vary. Successful production of CMV Virus specific T lymphocyte (VST) from donors will be tracked by a Yes/No question.
Production of cell accomplished: yes/no
Measured: up to 3 weeks
Feasibility: Participant Drop-out rate
Evaluation of feasibility of CMV specific T cell transfer in adult patients suffering from severe CMV infection following solid organ transplantation in part will be measured by participant drop out rate
Measured: up to 3 weeks
Feasibility: Time from patient inclusion to administration of CMV-VST
Evaluation of feasibility of CMV specific T cell transfer in adult patients suffering from severe CMV infection following solid organ transplantation in part will be measured by the amount of time from patient inclusion to administration of CMV-VST
Measured: up to 21 days
Efficacy: Percentage of patients with ≥1 log decrease in CMV viral load
Evaluation of efficacy of CMV-specific T-cell transfer in adult patients suffering from severe CMV infection following solid organ transplantation in part will be measured in terms of percentage of patients with ≥1 log decrease in CMV viral load at Week 12
Measured: up to 15 weeks
Efficacy:Time to 1 log change in CMV viral load
Evaluation of efficacy of CMV-specific T-cell transfer in adult patients suffering from severe CMV infection following solid organ transplantation in part will be measured in terms of time to 1 log change in CMV viral load
Measured: up to 15 weeks
Efficacy:Number of Participants with CMV clearance
Efficacy evaluation in part will be measured by number of participants with CMV clearance. Either negative polymerase chain reaction (PCR) or <250 copies/mL will be considered as CMV clearance.
Measured: up to 15 weeks
Efficacy: Time of clearance of CMV
Efficacy evaluation in part will be measured by number of days to achieve CMV clearance. Either negative polymerase chain reaction [PCR] or <250 copies/mL)will be considered as CMV clearance.
Measured: up to 55 weeks
Efficacy: Number of participants having CMV reactivation
Efficacy in part will be measured by number of participants with CMV reactivations following initial viral clearance
Measured: up to 55 weeks
Efficacy: Overall Survival of Participant
Overall survival rate of participants will be measured by time from T-cell transfer to death, graft loss, or last follow-up throughout the study
Measured: up to 55 weeks
Efficacy:Number of Participants with Clinical response/resolution of symptoms of underlying viral infection
Efficacy in part will be measured by number of patients with resolution of clinical symptoms of underlying CMV infection from Day 7 (Week 1) to Week 12 after T-cell transfer as compared to Day 0
Measured: up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start27 Sep 2019
- Primary completion11 Jul 2022
- Study completion11 Jul 2022
Why it stopped: Insufficient Patient Population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Model description
- 3+3 dose-escalation, open label, non-randomized, non-placebo controlled, single group assignment study
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandesh Parajuli, MBBS, Principal investigator, University of Wisconsin, MadisonJacques Galipeau, MD, Study director, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950414
- Sponsor's protocol ID
- 2019-0060
- Other IDs
- PACT VST-C-002, Protocol Version 11/1/2021
- Status last verified
- Feb 2024
- First submitted
- 15 Apr 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT03950414
- Acronym / sponsor ID
- 2019-0060
- Conditions
- Cytomegalovirus Infections, Solid Organ Transplant
- Keywords
- T-cell, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Patient Population
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 15 May 2019 (actual)
- 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.
This study measures the tolerability of viral-specific T cells against Cytomegalovirus (CMV) in adult solid organ transplant (SOT) recipients. Participants are expected to be on study for 52 +/- 3 weeks.
Detailed description
Viral infections, or their reactivation in the immunocompromised host, remain serious complications that adversely affect outcomes of transplantation. These infections may be refractory to pharmacologic treatment and result in increased morbidity and mortality after transplantation. Furthermore, the available pharmacologic therapies can result in severe toxicities.
Once an infection occurs, adequate immune reconstitution is decisive for recovery from viral disease after solid organ transplantation. The present trial will consist of the treatment of solid organ transplant recipients diagnosed with severe CMV infection when standard antiviral therapy is ineffective (disease progression on therapy, decline in viral load less than 10-fold in 2 weeks, known drug resistance), or toxic (end-organ damage), with virus-specific T cells using the CliniMACS® Prodigy System. These are the patients with the greatest unmet need and greatest risk or morbidity and allograft loss due to CMV infection. CMV-specific T cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV-specific T cells have been shown to be safe and efficacious in the treatment of CMV infections.
The primary objective of this Phase I trial is to evaluate the safety and tolerability of CMV-specific T-cell transfer in adult patients suffering from CMV infections following solid organ transplantation using a dose escalation design. The incubation with viral antigens (MACS GMP PepTivator) allows the enrichment of CMV-specific CD4+(Cluster of Differentiation 4) and CD8+(Cluster of Differentiation 8) T cells. Increasing evidence of the safety and efficacy of CMV-specific T-cell is available. Furthermore, the safety and efficacy of the specific manufacturing approach using the fully automated protocol of the ClinMACS® Prodigy for the isolation of CMV-specific T cells against CMV has been described and demonstrated that these cells retain their biological properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 dose-escalation, open label, non-randomized, non-placebo controlled, single group assignment study
| Arm | Type | Receives |
|---|---|---|
| Tier 1 | Experimental | Biological: CMV specific T-cells3 participants enrolled at dose level 5x10^3 cells/kg of CMV viral specific T-cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult (age ≥ 18 and ≤75) patients suffering from CMV reactivation/infections following solid organ transplantation (e.g., liver, pancreas, lung, heart, and multi-solid organ)
- Availability of eligible donor
- Written informed consent given by patient
Key exclusion criteria (19 listed)
- Patient with acute rejection of allograft at time of T-cell transfer
- Patient receiving steroids (>0.5 mg/kg body weight (BW) prednisone equivalent) at the time of T-cell transfer
- Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive monoclonal antibodies within 28 days
- Patients with CMV retinitis
- Concomitant enrollment in another clinical trial interfering with endpoints of this study
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 |
|---|---|---|
| CMV specific T-cellsNaturally occurring, allogeneic donor lymphocytes derived from a leukapheresis or a whole blood product, enriched for CMV-specific CD4+ and CD8+ T cells Suspension of CMV-specific T cells in 10 mL of 0.9% NaCl with 2% Human Serum Albumin(HSA) via IV bolus injection * Low Dose Tier - Viral-Specific T cell infusion 5 x10^3 cells/kg body weight(BW) * Mid Dose Tier - Viral-Specific T cell infusion 1.25 x10^4 cells/kg BW * High Dose Tier - Viral-Specific T cell infusion 2.5 x10^4 cells/kg BW Product will be administered fresh intravenously to recipient within four hours of collection. | Biological | Tier 1 |
Primary outcome
Safety and Tolerability:Time of Occurence of Acute GVHD
Time frame: up to 15 weeks
Time to occurrence of acute GVHD of any grade will be evaluated using the Kaplan-Meier method to assess incidence and severity of acute GVHD from day of T-cell transfer. The first day of GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that GVHD grade. Overall, cumulative incidence curves will be computed along with the 95% confidence intervals until Week 12 after T-cell transfer with death considered as a competing risk.
Safety and Tolerability: Number of infusion-related adverse events
Time frame: up to 7 weeks
Incidence of grades 3-5 infusion-related adverse events, grades 4-5 non-hematological adverse events within four weeks of the CMV-VST dose that are not due to the pre-existing infection or original malignancy or pre-existing co-morbidities
Incidence of acute infusion-related toxicity
Time frame: from T-cell transfer to 4 hours post injection, upto 3 weeks
Incidence of acute infusion-related toxicity as assessed by maximum toxicity on the day of T-cell transfer, evaluated by measuring vital signs prior to and at different times after the T-cell transfer and monitoring of specific adverse events (chills, nausea, vomiting, diarrhea, abdominal pain, allergic reactions, respiratory dysfunction or headache from T-cell transfer to 4 hours post injection)
Severity of acute infusion-related toxicity as measured by Cytokine release syndrome (CRS) Grading criteria
Time frame: from T-cell transfer to 4 hours post injection, upto 3 weeks
Severity of acute infusion-related toxicity will be assessed by CRS grading criteria. Grade 1 Symptoms are not life threatening and require symptomatic treatment only, (e.g., fever, nausea, fatigue, headache, myalgias, malaise) Grade 2 Symptoms require and respond to moderate intervention Grade 3 Symptoms require and respond to aggressive intervention Grade 4 Life-threatening symptoms Grade 5 Death Any grade 3 or greater occurrence of CRS will be considered a serious adverse event for this study.
Number of Participants of Newly Occurring Acute Rejection after T-cell Transfer
Time frame: up to 15 weeks
Incidence and severity of acute rejection of the organ allograft will in part be measured by number of participants of newly occurring acute rejection after T-cell transfer
Incidence of de novo Antibodies against Organ Allograft Donor (dnDSA) after T-cell Transfer
Time frame: up to 55 weeks
Incidence and severity of acute rejection of the organ allograft will in part be measured by presence of de novo antibodies against organ allograft donor (dnDSA) after T-cell transfer
Incidence of GVHD Grade ≥1
Time frame: up to 15 weeks
Incidence and severity of Graft-versus-host disease (GVHD) will be measured by occurrence of acute GVHD grade ≥1 or aggravation of pre-existing acute GVHD after T-cell transfer
10 secondary outcomes
Feasibility: Was production of CMV Virus specific T lymphocyte (VST) from donors accomplished?
Time frame: up to 3 weeks
Feasibility: Participant Drop-out rate
Time frame: up to 3 weeks
Feasibility: Time from patient inclusion to administration of CMV-VST
Time frame: up to 21 days
Efficacy: Percentage of patients with ≥1 log decrease in CMV viral load
Time frame: up to 15 weeks
Efficacy:Time to 1 log change in CMV viral load
Time frame: up to 15 weeks
Efficacy:Number of Participants with CMV clearance
Time frame: up to 15 weeks
Efficacy: Time of clearance of CMV
Time frame: up to 55 weeks
Efficacy: Number of participants having CMV reactivation
Time frame: up to 55 weeks
Efficacy: Overall Survival of Participant
Time frame: up to 55 weeks
Efficacy:Number of Participants with Clinical response/resolution of symptoms of underlying viral infection
Time frame: up to 15 weeks
Results and safety
The study was stopped early (reason given: Insufficient Patient Population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- 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.
Sandesh Parajuli, MBBS principal investigator
University of Wisconsin, Madison
Jacques Galipeau, MD study director
University of Wisconsin, Madison
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 CMV specific T-cells in people with Cytomegalovirus Infections and Solid Organ Transplant, run by University of Wisconsin, Madison 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 10 inclusion and 19 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: stopped early, as of the sponsor's last update on 20 Feb 2024. 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 was stopped early (reason given: Insufficient Patient Population). Results are not available in the source record.
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?
Safety and Tolerability:Time of Occurence of Acute GVHD (time frame: up to 15 weeks). The study lists 7 primary outcomes in all. 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 20 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.