Allogenic Stem Cell TransplantationPhase 1NCT07758218
Allogeneic iNKT Cell Therapy (agenT-797) After SCT
A Phase 1 study testing agenT-797 in people with Allogenic Stem Cell Transplantation and Myeloid Malignancies, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if agenT-797 is safe to use on people undergoing allogenic hematological stem cell transplantation (SCT). The main questions it aims to answer are: Is agenT-797 safe to use? What medical problems do participants have when taking agenT-797? Participants will receive an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogenic Stem Cell Transplantation, Myeloid Malignancies, Lymphoid Malignancies
- What is being tested?
- agenT-797
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Oct 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at the time of consent
- Adult patients anticipated to get an allogeneic hematopoietic cell transplantation (allo-SCT)
- All donor types are accepted (MMUD [mismatched unrelated donor], MUD [matched unrelated donor], MSD [matched sibling donor], haploidentical)
- All conditioning regimens will be accepted (MAC [myeloablative conditioning], RIC [reduced-intensity conditioning], NMAC [non-myeloablative conditioning])
- Karnofsky Performance Scale (KPS) > 70
- Eligible Diagnoses:
Show all 11Show fewer
- Acute myeloid leukemia (AML) with intermediate/high-risk features or relapsed disease
- Chronic myeloid leukemia (CML) in accelerated or blast phases
- Myelodysplastic syndrome (MDS) with intermediate/high-risk features
- Acute lymphoblastic leukemia (ALL) with high-risk features or relapsed disease
- or any patients undergoing allogeneic stem cell transplant (allo-SCT) as standard of care could be eligible
Who cannot join
- Excluded Diagnoses: Primary Myelofibrosis in the dose escalation phase and could be included in the dose-expansion phase
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Cancer Connect, 800-622-8922, clinicaltrials@cancer.wisc.edu
About this study
Official title: UW26004: Phase I Trial of Allogeneic iNKT Cell Therapy (agenT-797) in Patients Undergoing Allogeneic Hematological Stem Cell Transplantation (SCT)
The goal of this clinical trial is to learn if agenT-797 is safe to use on people undergoing allogenic hematological stem cell transplantation (SCT). The main questions it aims to answer are:
- Is agenT-797 safe to use?
- What medical problems do participants have when taking agenT-797?
Participants will receive an infusion of agenT-797 about 7 days after their allogenic SCT.
Read the detailed description
This study is being done to assess the safety and determine the maximum tolerated dose (MTD) of allogeneic invariant natural killer T (iNKT) cell therapy (agenT-797) in patients undergoing allogeneic hematological SCT.
- Conditions
- Allogenic Stem Cell Transplantation, Myeloid Malignancies, Lymphoid Malignancies, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome
- Being tested
- agenT-797
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
agenT-797Drug
agenT-797 is an off-the-shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT cells isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex vivo.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic iNKT Cells | Experimental | 3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks. Receives: Drug: agenT-797 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Participants With Treatment-related Adverse Events
This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
Measured: Baseline through Day 29 post cell infusion
Number Of Dose-limiting Toxicities
Measured: Baseline through Day 29 post cell infusion
Secondary outcomes (15)
Incidence of grade II-IV acute graft-versus-host disease (aGVHD)
Measured: Baseline through Day 29 post cell infusion
Incidence of severe grade III-IV aGVHD
Measured: Baseline through Day 29 post cell infusion
Progression-free Survival (PFS)
1-year PFS is the percentage of patients who are alive and whose cancer has not progressed within one year after receiving agenT-797.
Measured: 12 months
Non-relapse Mortalilty (NRM)
NRM is percentage of patients who died without recurrent or progressive disease after allo-SCT.
Measured: 12 months
Relapse-free Survival (RFS)
RFS is the length of time from agenT-797 administration until disease relapse or death.
Measured: 12 months
Overall survival (OS)
OS is the time from agenT-797 administration until death due to any cause.
Measured: 12 months
Immune reconstitution based on lymphocyte subset panel
Measured: 12 months
Immunoglobulin levels
Immune reconstitution measured through quantitative immunoglobulin levels
Measured: 12 months
Incidence of treatment-emergent adverse event (TEAE) infection
Measured: Baseline to 29 days post cell infusion
Type of infection
Description of type of infection, e.g., bacterial, viral, or fungal.
Measured: Baseline to 29 days post cell infusion
Donor Chimerism
Donor chimerism will be assessed and categorized as full/complete chimerism (DNA ≥ 95% donor in CD3+ compartment) or mixed chimerism (DNA < 95% donor in CD3+ compartment).
Measured: Baseline to 29 days post cell infusion
Absolute neutrophil count (ANC)
Measured: Baseline to 29 days post cell infusion
Non-relapse mortality rate (NRM)
NRM is percentage of participants who died without recurrent or progressive disease within 100 days after allo-SCT.
Measured: 100 days
Relapse rate
Relapse rate is percentage of participants who relapsed within 100 days after allo-SCT
Measured: 100 days
GVHD incidence
GVHD incidence rate at day 100 post SCT is the percentage of participants who experienced GVHD within 100 days after allo-SCT
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogenic Stem Cell TransplantationStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongtau Liu, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758218
- Sponsor's protocol ID
- 2026-0983
- Other IDs
- UWMSN | SMPH | DOM Hematology, UW26004, Protocol Version 6/10/26
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UW26004: Phase I Trial of Allogeneic iNKT Cell Therapy (agenT-797) in Patients Undergoing Allogeneic Hematological Stem Cell Transplantation (SCT)
- ClinicalTrials.gov ID
- NCT07758218
- Acronym / sponsor ID
- 2026-0983
- Conditions
- Allogenic Stem Cell Transplantation, Myeloid Malignancies, Lymphoid Malignancies, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 11 Aug 2026 (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 goal of this clinical trial is to learn if agenT-797 is safe to use on people undergoing allogenic hematological stem cell transplantation (SCT). The main questions it aims to answer are:
- Is agenT-797 safe to use?
- What medical problems do participants have when taking agenT-797?
Participants will receive an infusion of agenT-797 about 7 days after their allogenic SCT.
Detailed description
This study is being done to assess the safety and determine the maximum tolerated dose (MTD) of allogeneic invariant natural killer T (iNKT) cell therapy (agenT-797) in patients undergoing allogeneic hematological SCT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic iNKT Cells | Experimental | Drug: agenT-7973+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years at the time of consent
- Adult patients anticipated to get an allogeneic hematopoietic cell transplantation (allo-SCT)
- All donor types are accepted (MMUD [mismatched unrelated donor], MUD [matched unrelated donor], MSD [matched sibling donor], haploidentical)
- All conditioning regimens will be accepted (MAC [myeloablative conditioning], RIC [reduced-intensity conditioning], NMAC [non-myeloablative conditioning])
- Karnofsky Performance Scale (KPS) > 70
Key exclusion criteria (1 listed)
- Excluded Diagnoses: Primary Myelofibrosis in the dose escalation phase and could be included in the dose-expansion phase
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 |
|---|---|---|
| agenT-797agenT-797 is an off-the-shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT cells isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex vivo. | Drug | Allogeneic iNKT Cells |
Primary outcome
Number Of Participants With Treatment-related Adverse Events
Time frame: Baseline through Day 29 post cell infusion
This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
Number Of Dose-limiting Toxicities
Time frame: Baseline through Day 29 post cell infusion
15 secondary outcomes
Incidence of grade II-IV acute graft-versus-host disease (aGVHD)
Time frame: Baseline through Day 29 post cell infusion
Incidence of severe grade III-IV aGVHD
Time frame: Baseline through Day 29 post cell infusion
Progression-free Survival (PFS)
Time frame: 12 months
Non-relapse Mortalilty (NRM)
Time frame: 12 months
Relapse-free Survival (RFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
Immune reconstitution based on lymphocyte subset panel
Time frame: 12 months
Immunoglobulin levels
Time frame: 12 months
Incidence of treatment-emergent adverse event (TEAE) infection
Time frame: Baseline to 29 days post cell infusion
Type of infection
Time frame: Baseline to 29 days post cell infusion
Donor Chimerism
Time frame: Baseline to 29 days post cell infusion
Absolute neutrophil count (ANC)
Time frame: Baseline to 29 days post cell infusion
Non-relapse mortality rate (NRM)
Time frame: 100 days
Relapse rate
Time frame: 100 days
GVHD incidence
Time frame: 100 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes
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RecruitingObservational study
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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.
Hongtau Liu, MD, PhD principal investigator
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 agenT-797 in people with Allogenic Stem Cell Transplantation and Myeloid Malignancies, 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 11 inclusion and 1 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: opening soon, as of the sponsor's last update on 29 Oct 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongtau Liu, MD, PhD (608-263-6002, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Of Participants With Treatment-related Adverse Events (time frame: Baseline through Day 29 post cell infusion). 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 29 Oct 2026.