AdenovirusPhase 1/2NCT04364178
Viral Specific T-Lymphocytes to Treat Adenovirus, CMV and EBV
A Phase 1/2 study testing Adenovirus Specific T- Lymphocytes, Cytomegalovirus Specific T-Lymphocytes and EBV Specific T-Lymphocytes in people with Adenovirus and Cytomegalovirus Infections, run by Jessie L. Alexander, MD at 1 site in United States.
Trial summary
The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV or EBV in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Read more about this study
- Who is it for?
- Ages 1 month to 65 years
- Conditions the study is for
- Adenovirus, Cytomegalovirus Infections, Epstein-Barr Virus
- What is being tested?
- Adenovirus Specific T- Lymphocytes, Cytomegalovirus Specific T-Lymphocytes and EBV Specific T-Lymphocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 11 Nov 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 month to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient, parent, or legal guardian must have given written informed consent, according to FDA guidelines. For patients ≥ 7 years of age who are developmentally able, assent or affirmation will be obtained, if feasible.
- Male or female, 1 month through 65 years old, inclusive, at the time of informed consent.
- Prior allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood stem cells, single or double cord blood), OR prior solid organ transplant (liver, kidney, lung and/or heart, intestinal, or multivisceral), OR diagnosis of primary immunodeficiency OR current/recent administration of immunosuppressive therapy for cancer or autoimmune disease.
- Clinical status, at time of consent, amendable to tapering of steroids to less than 1 mg/kg/day prednisone (or equivalent) prior to cellular infusion.
- Negative pregnancy test for females ≥10 years old or who have reached menarche, unless surgically sterilized.
- Diagnosis of Adenovirus or CMV infection, persistent despite standard therapy.
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- Adenovirus Infection or Disease:
- Active adenovirus infection: (i.e. gastroenteritis, pneumonia, hemorrhagic cystitis, hepatitis, pancreatitis, meningitis) defined as the demonstration of adenovirus by biopsy specimen from affected site(s) (by culture or histology), or the detection of adenovirus by culture, PCR or direct fluorescent antibody stain in fluid in the presence of worsening or persistent clinical or imaging findings despite at least 14 days of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents) OR
- Refractory adenoviremia: defined as DNAemia >5000 copies/mL or <1 log decrease after at least 2 weeks of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents) OR
- Intolerance of or contraindication to antiviral medications.
- CMV Infection or Disease:
- Active CMV infection: (i.e. pneumonia, meningitis, retinitis, hepatitis, hemorrhagic cystitis, and/or gastroenteritis) defined as the demonstration of CMV by biopsy specimen from affected site(s) (by culture or histology) or the detection of CMV by culture, PCR or direct fluorescent antibody stain in fluid in the presence of worsening or persistent clinical or imaging findings despite at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other available pharmacological agents) OR
- Refractory CMV viremia: defined as the continued presence of DNAemia, with ≥2,000 IU/mL or <1 log decrease after at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other available pharmacological agents) OR
- Intolerance of or contraindication to antiviral medications.
- EBV Infection or Disease:
- Biopsy proven lymphoma or posttransplant lymphoproliferative disease with EBV genomes detected in tumor cells by immunocytochemistry (i.e. EBER positive) or in situ PCR, OR
- Clinical or imaging findings consistent with EBV lymphoma and associated elevated EBV viral load in peripheral blood in a patient where biopsy is deemed too high risk, OR
- Failure of antiviral therapy, as determined by one of the two bullets below after three weeks of anti-CD20 targeted therapy such as Rituximab.
- There was an increase or less than 50% response at sites of lymphoma disease or lymphoproliferation. ii. There was a rise or a fall of less than 50% in EBV viral load in peripheral blood of PTLD patients.
Who cannot join
- Received ATG or Alemtuzumab within 28 days of viral-specific T cell infusion and a lack of evidence of T cell survival, defined by <10 CD3+ T cells/uL (in unique situations, plasmapheresis may be considered).
- Active acute GVHD grades II-IV.
- Active severe chronic GVHD.
- Received donor lymphocyte infusion, with the exception of a fraction of an umbilical cord blood, within 21 days of viral-specific T cell infusion. Subjects receiving a fraction of an umbilical cord blood within 21 days of the viral-specific T cell infusion will not be excluded.
- Active and uncontrolled relapse of malignancy.
- Anticipated initiation of new lymphotoxic therapy within 4 weeks of viral-specific T cell infusion.
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- Patients who are pregnant or lactating.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks to participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
- Donor Inclusion Criteria
- 12 years of age or older
- Able to understand and consent/assent to the procedure
- Required hemoglobin of 11g/dL or greater
- Partial (2/6 or more) HLA match to the recipient
- Donor Exclusion Criteria
- Donor is pregnant
- Donor is HIV positive
- Donor is positive for hepatitis B and/or hepatitis C
- Uncontrolled infection
- Deemed to be a high risk donor based on responses to donor risk questionnaire
- Deemed high risk due to pre-existing medical condition or abnormal lab results
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC (University of Pittsburgh Medical Center)
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Viral Specific T-Lymphocytes by Cytokine Capture System (CCS) to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus After Hematopoietic Cell Transplantation or Solid Organ Transplantation and in Patients With Compromised Immunity
The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV or EBV in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with DNA viruses. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. In this trial, we will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and/or SOT recipients, and/or patients with compromised immunity who have adenovirus or CMV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.
Read the detailed description
If a subject shows a partial response, defined as a decrease in viral load of at least 50% from baseline or 50% improvement of clinical signs and symptoms, or no response, they are eligible to receive up to 4 additional cellular infusions from the same donor, at a minimum of 14-day intervals. If the same donor is no longer available, eligible, or appropriate, another donor may be considered for a maximum of 4 total cellular infusions at the discretion of the study PI and treating physician. A subject will not exceed a maximum of 5 total infusions from 2 donors.
Subjects are followed for 1 year post initial viral-specific T cell infusion. If subjects receive additional infusion(s), GvHD and adverse events will be followed for an additional 90 days from last infusion. Data may be abstracted from subjects' medical charts for an additional 1 year after most recent viral-specific T cell infusion.
- Conditions
- Adenovirus, Cytomegalovirus Infections, Epstein-Barr Virus
- Being tested
- Adenovirus Specific T- Lymphocytes, Cytomegalovirus Specific T-Lymphocytes, EBV Specific T-Lymphocytes
- Keywords
- Cytokine Capture System, Adenovirus, Cytomegalovirus, Hematopoietic Cell Transplant, Solid Organ Transplant, Immunocompromised, Inborn Error of Immunity
- Medical subject headings
- Adenoviridae Infections, Cytomegalovirus Infections, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenovirus Specific T- LymphocytesBiological
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-LymphocytesBiological
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
EBV Specific T-LymphocytesBiological
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Epstein barr viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
| Study group | Role | What they receive |
|---|---|---|
| Viral Specific T-Lymphocytes | Experimental | Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Receives: Biological: Adenovirus Specific T- Lymphocytes; Biological: Cytomegalovirus Specific T-Lymphocytes; Biological: EBV Specific T-Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Grade III-IV Acute Graft Versus Host Disease
Cumulative number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Measured: Day 0 through 90 days after last cellular infusion (last infusion occurred up to 38 days post day 0)
Number of Patients Who Experienced Grade 4/5 Adverse Events After Infusion
Cumulative number of patients with CTCAE Grade 4/5 Adverse events which occurred after infusion
Measured: Day 0 through 90 days after last cellular infusion (last infusion occurred up to 38 days post day 0)
Secondary outcomes (6)
Number of Patients Who Reached 6 Month Survival
Cumulative number of patients surviving at 6 months
Measured: First cellular infusion to 6 months post first cellular infusion (last infusion occurred up to 38 days post day 0)
Number of Patients Who Achieved One Year Survival
Cumulative number of patients who were treated and surviving one year later
Measured: 1 year after first infusion
Patients Who Achieved Viral Response (Complete Response) to Treatment
Complete response to the virus is defined as a resolution of viremia or below limit of quantification OR complete resolution of all related clinical signs and symptoms for CMV, non lymphoproliferative EBV, and adenovirus. For lymphoproliferative EBV, complete response is defined as the resolution of related radiographic disease.
Measured: 1, 3, and 6 months after first infusion
Number of Days to Patient Complete Response to Viral Specific Infusion
Complete response to the virus is defined as a resolution of viremia or below limit of quantification OR complete resolution of all related clinical signs and symptoms for CMV, non lymphoproliferative EBV, and adenovirus. For lymphoproliferative EBV, complete response is defined as the resolution of related radiographic disease.
Measured: Baseline through 6 months after last infusion
Number of Days Post-VST Infusion Upon Which Viral Specific Antimicrobial Treatment Was Discontinued.
The number of days after the VST infusion that the antiviral agent used for treatment of the specific virus was stopped.
Measured: Day 0 through 6 months after last infusion
Number of Days Post VST Infusion That Patients Achieved T Cell Immune Reconstitution
Immune reconstitution is defined as CD4 lymphocyte count greater than 50/microliter
Measured: Baseline through 6 months after last infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start12 Aug 2020
- Primary completion9 Feb 2023
- Study completion11 Nov 2023
Why it stopped: Sponsor Investigator Moved To Stanford
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AdenovirusStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessie L. Alexander, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jessie L. Alexander, MD, Stanford University
- Investigators
- Jessie Alexander, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364178
- Sponsor's protocol ID
- STUDY19040088
- Status last verified
- May 2026
- First submitted
- 23 Apr 2020
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Specific T-Lymphocytes by Cytokine Capture System (CCS) to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus After Hematopoietic Cell Transplantation or Solid Organ Transplantation and in Patients With Compromised Immunity
- ClinicalTrials.gov ID
- NCT04364178
- Acronym / sponsor ID
- STUDY19040088
- Conditions
- Adenovirus, Cytomegalovirus Infections, Epstein-Barr Virus
- Keywords
- Cytokine Capture System, Adenovirus, Cytomegalovirus, Hematopoietic Cell Transplant, Solid Organ Transplant, Immunocompromised, Inborn Error of Immunity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Investigator Moved To Stanford
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Jessie L. Alexander, MDUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Posted 27 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV or EBV in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with DNA viruses. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. In this trial, we will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and/or SOT recipients, and/or patients with compromised immunity who have adenovirus or CMV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.
Detailed description
If a subject shows a partial response, defined as a decrease in viral load of at least 50% from baseline or 50% improvement of clinical signs and symptoms, or no response, they are eligible to receive up to 4 additional cellular infusions from the same donor, at a minimum of 14-day intervals. If the same donor is no longer available, eligible, or appropriate, another donor may be considered for a maximum of 4 total cellular infusions at the discretion of the study PI and treating physician. A subject will not exceed a maximum of 5 total infusions from 2 donors.
Subjects are followed for 1 year post initial viral-specific T cell infusion. If subjects receive additional infusion(s), GvHD and adverse events will be followed for an additional 90 days from last infusion. Data may be abstracted from subjects' medical charts for an additional 1 year after most recent viral-specific T cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Viral Specific T-Lymphocytes | Experimental | Biological: Adenovirus Specific T- Lymphocytes, Biological: Cytomegalovirus Specific T-Lymphocytes, Biological: EBV Specific T-LymphocytesPeripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. |
Who may qualify
- Ages
- 1 month to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Patient, parent, or legal guardian must have given written informed consent, according to FDA guidelines. For patients ≥ 7 years of age who are developmentally able, assent or affirmation will be obtained, if feasible.
- Male or female, 1 month through 65 years old, inclusive, at the time of informed consent.
- Prior allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood stem cells, single or double cord blood), OR prior solid organ transplant (liver, kidney, lung and/or heart, intestinal, or multivisceral), OR diagnosis of primary immunodeficiency OR current/recent administration of immunosuppressive therapy for cancer or autoimmune disease.
- Clinical status, at time of consent, amendable to tapering of steroids to less than 1 mg/kg/day prednisone (or equivalent) prior to cellular infusion.
- Negative pregnancy test for females ≥10 years old or who have reached menarche, unless surgically sterilized.
Key exclusion criteria (20 listed)
- Received ATG or Alemtuzumab within 28 days of viral-specific T cell infusion and a lack of evidence of T cell survival, defined by <10 CD3+ T cells/uL (in unique situations, plasmapheresis may be considered).
- Active acute GVHD grades II-IV.
- Active severe chronic GVHD.
- Received donor lymphocyte infusion, with the exception of a fraction of an umbilical cord blood, within 21 days of viral-specific T cell infusion. Subjects receiving a fraction of an umbilical cord blood within 21 days of the viral-specific T cell infusion will not be excluded.
- Active and uncontrolled relapse of malignancy.
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 |
|---|---|---|
| Adenovirus Specific T- LymphocytesPeripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. | Biological | Viral Specific T-Lymphocytes |
| Cytomegalovirus Specific T-LymphocytesPeripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. | Biological | Viral Specific T-Lymphocytes |
| EBV Specific T-LymphocytesPeripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Epstein barr viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. | Biological | Viral Specific T-Lymphocytes |
Primary outcome
Number of Patients With Grade III-IV Acute Graft Versus Host Disease
Time frame: Day 0 through 90 days after last cellular infusion (last infusion occurred up to 38 days post day 0)
Cumulative number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Number of Patients Who Experienced Grade 4/5 Adverse Events After Infusion
Time frame: Day 0 through 90 days after last cellular infusion (last infusion occurred up to 38 days post day 0)
Cumulative number of patients with CTCAE Grade 4/5 Adverse events which occurred after infusion
6 secondary outcomes
Number of Patients Who Reached 6 Month Survival
Time frame: First cellular infusion to 6 months post first cellular infusion (last infusion occurred up to 38 days post day 0)
Number of Patients Who Achieved One Year Survival
Time frame: 1 year after first infusion
Patients Who Achieved Viral Response (Complete Response) to Treatment
Time frame: 1, 3, and 6 months after first infusion
Number of Days to Patient Complete Response to Viral Specific Infusion
Time frame: Baseline through 6 months after last infusion
Number of Days Post-VST Infusion Upon Which Viral Specific Antimicrobial Treatment Was Discontinued.
Time frame: Day 0 through 6 months after last infusion
Number of Days Post VST Infusion That Patients Achieved T Cell Immune Reconstitution
Time frame: Baseline through 6 months after last infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jessie Alexander, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adenovirus Specific T- Lymphocytes, Cytomegalovirus Specific T-Lymphocytes and EBV Specific T-Lymphocytes in people with Adenovirus and Cytomegalovirus Infections, run by Jessie L. Alexander, MD 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 19 inclusion and 20 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 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Patients With Grade III-IV Acute Graft Versus Host Disease (time frame: Day 0 through 90 days after last cellular infusion (last infusion occurred up to 38 days post day 0)). The study lists 2 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 27 May 2026.