Acute LeukemiaPhase 1NCT04328714
Interferon γ-Primed Mesenchymal Stromal Cells as Prophylaxis for Acute Graft v Host Disease
A Phase 1 study testing Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells in people with Acute Leukemia and Myelodysplastic Syndromes, run by Edwin Horwitz at 3 sites in United States.
Trial summary
The protocol is a phase I open label study evaluating the safety and feasibility of peri-transplant infusion of freshly expanded interferon gamma primed MSCs in adult and pediatric patients undergoing HCT for acute leukemia and myelodysplastic syndrome (MDS). Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Acute Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Dec 2021to 20 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All transplant patients who undergo HCT with a myeloablative (MA) or Fludarabine/Melphalan (RIC) conditioning regimen and a HLA A- B- C- DR-matched unrelated donor as treatment for hematologic malignancy or MDS.
- Age ≥ 1 year at the time that the informed consent document is signed.
- Patients with acute leukemia must be in complete remission (defined as an M1 marrow -<5% blasts- no evidence of extramedullary disease. Complete remissions without platelet recovery (CRp) will be considered remissions.
- Planned GVHD prophylaxis with a calcineurin inhibitor and methotrexate per institutional standards.
- Subject or parent/guardian must sign an informed consent document, and if appropriate, children must sign an assent document.
Who cannot join
- Patients who are to receive a non-myeloablative conditioning regimen.
- Patients receiving another investigational drug for acute GVHD prevention during the conditioning regimen or a planned investigational drug for the first year after transplant (there are no restrictions on GVHD treatment).
- Any medical or psychological condition or situation deemed by the Investigators to put the patient at increased risk of complications or non-compliance.
- Patient with a secondary malignancy who would be otherwise eligible for study, but for whom remission from the primary disease cannot be conclusively confirmed or for whom the chance of relapse of the primary disease is significant.
- Pregnancy (positive serum b-HCG) or breastfeeding.
- Estimated glomerular filtration rate (GFR) of < 50 mL/min/1.73m2.
Show all 11Show fewer
- Cardiac ejection fraction < 50 (using M-Mode if assessment is done by Echocardiogram)
- T bilirubin > 2 × upper limit of normal or alanine aminotransferase (ALT) > 4 × upper limit of normal or aspartate aminotransferase (AST) > 4 x upper limit of normal unresolved veno-occlusive disease
- Pulmonary disease with forced vital capacity (FVC), forced expiratory volume (FEV1) or diffusing capacity for carbon monoxide (DLCO) parameters <45% predicted (corrected for hemoglobin) or requiring supplemental oxygen. Children who are developmentally unable to perform pulmonary function testing will be assessed solely on their need for supplemental oxygen.
- Karnofsky performance score or Lansky Play-Performance Scale score <80
- Human leukocyte antigen (HLA) antibody screen positive for HLA antibodies specific against the MSC products.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30322
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
About this study
Official title: Interferon γ-Primed Mesenchymal Stromal Cells as Prophylaxis for Acute Graft v Host Disease After Allogeneic Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies and Myelodysplasia
The protocol is a phase I open label study evaluating the safety and feasibility of peri-transplant infusion of freshly expanded interferon gamma primed MSCs in adult and pediatric patients undergoing HCT for acute leukemia and myelodysplastic syndrome (MDS).
Read the detailed description
Hematopoietic cell transplantation (HCT) is an established therapeutic modality for high risk hematological malignancies in adults and children. The primary cause of morbidity and mortality after HCT is graft versus host disease (GVHD), affecting up to 70% of patients even with current prophylaxis and directly accounting for approximately a third of regimen-related death. Currently, pharmacologic prophylaxis consists of a calcineurin inhibitor and methotrexate, a drug combination introduced around 40 years ago. Despite this regimen being recognized as the standard of care, it is only partially effective, increases the risk of infection and disease relapse and imparts drug-related, short- and long-term adverse effects. Mesenchymal stromal cells (MSCs) have potent immune modulatory activity which is markedly enhanced by exposure to interferon γ. In murine models, interferon γ (IFNγ) primed MSCs (γMSCs) potently suppress GVHD without untoward adverse effects suggesting this cell therapy may markedly reduce the regimen related toxicity of HCT; however γMSCs have never been infused into patients.
This protocol is designed to test the hypothesis that freshly expanded γMSCs can be reliably produced and safely infused into patients undergoing HCT as GVHD prophylaxis.
This is an investigator-initiated Phase I study using a rolling 6, dose escalation design with two independently accruing expansion cohorts: adults and pediatrics. Accrual to the pediatric tier will commence after the maximum tolerated dose (MTD) has been determined in adults. A successful outcome of this study will lay the foundation for a future Phase II study to demonstrate efficacy and support a Phase III randomized trial.
The researchers plan to enroll a minimum of 4 and maximum of 45 subjects who are greater than 1 year old. Participants will be followed for up to 2 years after the HCT. The study will be conducted at Emory University and will recruit participants from the Winship Cancer Institute and Children's Hospital in Atlanta at Egleston.
- Conditions
- Acute Leukemia, Myelodysplastic Syndromes
- Being tested
- Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells
- Keywords
- Interferon Gamma (IFN γ), Graft versus Host Disease (GVHD), Allogeneic Hematopoietic Cell Transplantation
- Medical subject headings
- Myelodysplastic Syndromes, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cellsDrug
To determine the maximal dose, initially adult subjects will receive a single infusion of third party, freshly ex vivo expanded, IFNγ-primed MSCs at a dose of 2 x 106 cells/kg of ideal body weight on Day +1 (the day after infusion of the hematopoietic cell graft). The dose will be escalated to 5 x 106 and then 10 x 106 cells/kg. In absence of any dose limiting toxicity, 10 x 106 cells/kg will be accepted as the maximal dose.
Subsequent participants in the adult and pediatric cohorts will receive the maximal dose as determined by the initial adult participants.
Participants will receive the infusion in an inpatient setting. MSCs will be intravenously infused through a central line or a large bore peripheral IV using standard blood product tubing within 4 hours of release. The product will be infused by IV push or syringe pump over approximately 30-60 minutes or to gravity depending on product volume.
| Study group | Role | What they receive |
|---|---|---|
| Adult Population | Experimental | Study participants aged 18 or older who are having an allogeneic blood and marrow transplant (BMT), to treat leukemia, lymphoma or other cancer of the blood will receive an infusion of mesenchymal stromal cells (MSCs). Receives: Drug: Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells |
| Pediatric Population | Experimental | Study participants under 18 years of age who are having an allogeneic blood and marrow transplant (BMT), to treat leukemia, lymphoma or other cancer of the blood will receive an infusion of mesenchymal stromal cells (MSCs). Receives: Drug: Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful preparations and deliveries of investigational product
Feasibility will be documented by successful γMSC preparation and delivery to the bedside. If an adverse event precludes initiation or completion of the infusion, this MSC preparation/infusion will, nonetheless, be considered feasible. Processing scored as a not feasible will consist of a cell preparation does not meet release criteria.
Measured: Day 1 (day of infusion)
Number of adverse events attributed to the investigational product
Safety will be assessed by toxicity grading according to the Common Terminology Criteria for Adverse Events, version 4 (CTCAEv4). All recorded adverse events and serious adverse events will be documented and recorded. Their attribution to γMSCs will be determined. Dose limiting toxicity definition: For this study, dose limiting toxicities (DLTs) will be defined as any grade ≥3 adverse reaction AND attributable to γMSCs (attribution listed as at least probable), occurring from γMSC infusion through the day of hematopoietic engraftment or 21 days of transplant, whichever is later.
Measured: Day 2 (day after infusion)
Maximal Tolerated Dose
The maximal tolerated dose will be the dose at which 0 of 3 or 1 of 6 subjects demonstrates a DLT. If a dose of 10 x 106 γMSCs/kg is determined to be safe, then we will not determine the true MTD and accept 10 x 106 γMSCs/kg as the maximal dose.
Measured: Day 2 (day after infusion)
Secondary outcomes (11)
Primary graft failure
This endpoint will be defined as lack of neutrophil recovery (defined as ANC > 500/μL for three consecutive days) by 42 days post-transplant or neutrophil recovery with lack of myeloid donor chimerism. Relapse and death prior to neutrophil engraftment are considered competing risks for the endpoint of primary graft failure.
Measured: Up to Year 2
Secondary graft failure
Secondary graft failure is defined as initial donor-derived neutrophil engraftment followed by subsequent decline in absolute neutrophil count (ANC) to < 500/μL for fourteen consecutive measurements on different days, and unresponsive to growth factor therapy, with loss of donor chimerism to < 50%.
Measured: Up to Year 2
Platelet engraftment
Platelet engraftment is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count > 20,000/μL and > 50,000/μL with no platelet transfusions in the preceding seven days. The first day of the three measurements will be designated as the day of platelet engraftment.
Measured: Up to Year 2
Non-relapse mortality (NRM)
The event is death in continuous remission treating relapse as the competing risk. Patients alive and in remission at the time of last observation will be censored.
Measured: Up to Year 2
Change in Acute graft-versus-host disease (aGvHD) Incidence
Incidences of grade II-IV and III-IV acute GvHD will be measured according to Revised Glucksberg criteria.
Measured: Day 30, Day 100
Change in Chronic graft-versus-host disease (cGvHD) Incidence
Incidence of chronic GvHD will be scored according to the recent NIH scoring.
Measured: Day 30, Day 100, Day 180, Day 365
Disease-free survival (DFS)
Disease-free survival is defined as the minimum time interval from transplant to relapse/recurrence of disease, to death or to last follow-up.
Measured: Up to Year 2
Primary cause of death
Primary cause of death will be classified as:
Relapse/Primary disease: If the patient relapsed/progressed after day 0 prior to death, the primary cause of death is relapse/progression, even if they subsequently developed GvHD, organ toxicities or infections that may have contributed to subsequent death. GvHD: Death from acute or chronic GvHD, in the absence of relapse or disease progression.
Infection: Death from documented viral, bacterial or fungal infections in the absence of GvHD or relapse/disease progression.
Organ toxicity: Death from major organ toxicities not attributable to acute myeloid leukemia (AML)/MDS, infection or GvHD.
Other: Any other causes of death.
Measured: Up to Year 2
Relapse
Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of AML, acute lymphoblastic leukemia (ALL) or MDS and including minimal residual disease (MRD) in ALL consistent with pre-transplant features. The event for this endpoint is the time interval from transplant to relapse/recurrence of disease or to last follow-up. Death in remission is considered a competing risk.
Measured: Up to Year 2
Early discontinuation
If a patient is enrolled on the study but does not start protocol treatment, a study exit form must be submitted documenting the reason for not starting protocol treatment. Such a subject will not be considered evaluable.
Measured: Up to Year 2
Viral activation
Viral activations of cytomegalovirus (CMV) and Epstein-Barr virus (EBV) will be documented. For the purpose of the study viral activation is defined as any polymerase chain reaction (PCR) assay result considered positive by Laboratory Medicine which may or may not lead to the initiation of antiviral therapy as per institutional guidelines.
Measured: Up to Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start2 Dec 2021
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Why it stopped: Study was suspended pending renovation and reopening of the facility manufacturing the study product, and the study was ultimately terminated in February of 2026.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies 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
- Sequential
- Model description
- This study uses a rolling 6 dose escalation design with two independently accruing expansion cohorts: adults and pediatrics. Accrual in the pediatric tier will commence after the maximum dose tolerated has been determined in adults.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwin Horwitz
- Sponsor type
- University, hospital or other
- Collaborators
- Ossium Health, Inc.
- Responsible party
- Sponsor-investigator, Edwin Horwitz, Emory University
- Investigators
- Edwin Horwitz, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328714
- Sponsor's protocol ID
- IRB00105305
- Status last verified
- Feb 2026
- First submitted
- 30 Mar 2020
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article will be made available for sharing. T cell repertoire data will be submitted to a public data base.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon γ-Primed Mesenchymal Stromal Cells as Prophylaxis for Acute Graft v Host Disease After Allogeneic Hematopoietic Cell Transplantation for Patients With Hematologic Malignancies and Myelodysplasia
- ClinicalTrials.gov ID
- NCT04328714
- Acronym / sponsor ID
- IRB00105305
- Conditions
- Acute Leukemia, Myelodysplastic Syndromes
- Keywords
- Interferon Gamma (IFN γ), Graft versus Host Disease (GVHD), Allogeneic Hematopoietic Cell Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was suspended pending renovation and reopening of the facility manufacturing the study product, and the study was ultimately terminated in February of 2026.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Edwin HorwitzUniversity, hospital or other
- Collaborators
- Ossium Health, Inc.
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 31 Mar 2020 (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.
The protocol is a phase I open label study evaluating the safety and feasibility of peri-transplant infusion of freshly expanded interferon gamma primed MSCs in adult and pediatric patients undergoing HCT for acute leukemia and myelodysplastic syndrome (MDS).
Detailed description
Hematopoietic cell transplantation (HCT) is an established therapeutic modality for high risk hematological malignancies in adults and children. The primary cause of morbidity and mortality after HCT is graft versus host disease (GVHD), affecting up to 70% of patients even with current prophylaxis and directly accounting for approximately a third of regimen-related death. Currently, pharmacologic prophylaxis consists of a calcineurin inhibitor and methotrexate, a drug combination introduced around 40 years ago. Despite this regimen being recognized as the standard of care, it is only partially effective, increases the risk of infection and disease relapse and imparts drug-related, short- and long-term adverse effects. Mesenchymal stromal cells (MSCs) have potent immune modulatory activity which is markedly enhanced by exposure to interferon γ. In murine models, interferon γ (IFNγ) primed MSCs (γMSCs) potently suppress GVHD without untoward adverse effects suggesting this cell therapy may markedly reduce the regimen related toxicity of HCT; however γMSCs have never been infused into patients.
This protocol is designed to test the hypothesis that freshly expanded γMSCs can be reliably produced and safely infused into patients undergoing HCT as GVHD prophylaxis.
This is an investigator-initiated Phase I study using a rolling 6, dose escalation design with two independently accruing expansion cohorts: adults and pediatrics. Accrual to the pediatric tier will commence after the maximum tolerated dose (MTD) has been determined in adults. A successful outcome of this study will lay the foundation for a future Phase II study to demonstrate efficacy and support a Phase III randomized trial.
The researchers plan to enroll a minimum of 4 and maximum of 45 subjects who are greater than 1 year old. Participants will be followed for up to 2 years after the HCT. The study will be conducted at Emory University and will recruit participants from the Winship Cancer Institute and Children's Hospital in Atlanta at Egleston.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a rolling 6 dose escalation design with two independently accruing expansion cohorts: adults and pediatrics. Accrual in the pediatric tier will commence after the maximum dose tolerated has been determined in adults.
| Arm | Type | Receives |
|---|---|---|
| Adult Population | Experimental | Drug: Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cellsStudy participants aged 18 or older who are having an allogeneic blood and marrow transplant (BMT), to treat leukemia, lymphoma or other cancer of the blood will receive an infusion of mesenchymal stromal cells (MSCs). |
| Pediatric Population | Experimental | Drug: Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cellsStudy participants under 18 years of age who are having an allogeneic blood and marrow transplant (BMT), to treat leukemia, lymphoma or other cancer of the blood will receive an infusion of mesenchymal stromal cells (MSCs). |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All transplant patients who undergo HCT with a myeloablative (MA) or Fludarabine/Melphalan (RIC) conditioning regimen and a HLA A- B- C- DR-matched unrelated donor as treatment for hematologic malignancy or MDS.
- Age ≥ 1 year at the time that the informed consent document is signed.
- Patients with acute leukemia must be in complete remission (defined as an M1 marrow -<5% blasts- no evidence of extramedullary disease. Complete remissions without platelet recovery (CRp) will be considered remissions.
- Planned GVHD prophylaxis with a calcineurin inhibitor and methotrexate per institutional standards.
- Subject or parent/guardian must sign an informed consent document, and if appropriate, children must sign an assent document.
Key exclusion criteria (11 listed)
- Patients who are to receive a non-myeloablative conditioning regimen.
- Patients receiving another investigational drug for acute GVHD prevention during the conditioning regimen or a planned investigational drug for the first year after transplant (there are no restrictions on GVHD treatment).
- Any medical or psychological condition or situation deemed by the Investigators to put the patient at increased risk of complications or non-compliance.
- Patient with a secondary malignancy who would be otherwise eligible for study, but for whom remission from the primary disease cannot be conclusively confirmed or for whom the chance of relapse of the primary disease is significant.
- Pregnancy (positive serum b-HCG) or breastfeeding.
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 |
|---|---|---|
| Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cellsTo determine the maximal dose, initially adult subjects will receive a single infusion of third party, freshly ex vivo expanded, IFNγ-primed MSCs at a dose of 2 x 106 cells/kg of ideal body weight on Day +1 (the day after infusion of the hematopoietic cell graft). The dose will be escalated to 5 x 106 and then 10 x 106 cells/kg. In absence of any dose limiting toxicity, 10 x 106 cells/kg will be accepted as the maximal dose. Subsequent participants in the adult and pediatric cohorts will receive the maximal dose as determined by the initial adult participants. Participants will receive the infusion in an inpatient setting. MSCs will be intravenously infused through a central line or a large bore peripheral IV using standard blood product tubing within 4 hours of release. The product will be infused by IV push or syringe pump over approximately 30-60 minutes or to gravity depending on product volume. | Drug | Adult Population, Pediatric Population |
Primary outcome
Number of successful preparations and deliveries of investigational product
Time frame: Day 1 (day of infusion)
Feasibility will be documented by successful γMSC preparation and delivery to the bedside. If an adverse event precludes initiation or completion of the infusion, this MSC preparation/infusion will, nonetheless, be considered feasible. Processing scored as a not feasible will consist of a cell preparation does not meet release criteria.
Number of adverse events attributed to the investigational product
Time frame: Day 2 (day after infusion)
Safety will be assessed by toxicity grading according to the Common Terminology Criteria for Adverse Events, version 4 (CTCAEv4). All recorded adverse events and serious adverse events will be documented and recorded. Their attribution to γMSCs will be determined. Dose limiting toxicity definition: For this study, dose limiting toxicities (DLTs) will be defined as any grade ≥3 adverse reaction AND attributable to γMSCs (attribution listed as at least probable), occurring from γMSC infusion through the day of hematopoietic engraftment or 21 days of transplant, whichever is later.
Maximal Tolerated Dose
Time frame: Day 2 (day after infusion)
The maximal tolerated dose will be the dose at which 0 of 3 or 1 of 6 subjects demonstrates a DLT. If a dose of 10 x 106 γMSCs/kg is determined to be safe, then we will not determine the true MTD and accept 10 x 106 γMSCs/kg as the maximal dose.
11 secondary outcomes
Primary graft failure
Time frame: Up to Year 2
Secondary graft failure
Time frame: Up to Year 2
Platelet engraftment
Time frame: Up to Year 2
Non-relapse mortality (NRM)
Time frame: Up to Year 2
Change in Acute graft-versus-host disease (aGvHD) Incidence
Time frame: Day 30, Day 100
Change in Chronic graft-versus-host disease (cGvHD) Incidence
Time frame: Day 30, Day 100, Day 180, Day 365
Disease-free survival (DFS)
Time frame: Up to Year 2
Primary cause of death
Time frame: Up to Year 2
Relapse
Time frame: Up to Year 2
Early discontinuation
Time frame: Up to Year 2
Viral activation
Time frame: Up to Day 100
Results and safety
The study was stopped early (reason given: Study was suspended pending renovation and reopening of the facility manufacturing the study product, and the study was ultimately terminated in February of 2026.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article will be made available for sharing. T cell repertoire data will be submitted to a public data base.
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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.
Edwin Horwitz, MD, PhD principal investigator
Emory University
3 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 Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells in people with Acute Leukemia and Myelodysplastic Syndromes, run by Edwin Horwitz at 3 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 5 inclusion and 11 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 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: Study was suspended pending renovation and reopening of the facility manufacturing the study product, and the study was ultimately terminated in February of 2026.). 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?
Number of successful preparations and deliveries of investigational product (time frame: Day 1 (day of infusion)). 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?
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 13 Feb 2026.