A Phase 1 interventional study of agenT-797 in Allogenic Stem Cell Transplantation, Myeloid Malignancies and Lymphoid Malignancies, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University of Wisconsin, Madison · Phase 1, Interventional, and Supportive care
Among 2,137 studies in Leukemia, Myeloid, Acute with a site in United States — 312 open to participants now, 465 under way, 24 of them phase 3. Leukemia, Myeloid, Acute · United States.
Among the 2,137 studies in Leukemia, Myeloid, Acute with a site in United States, this one is the 1,246th largest by planned enrollment of the 1,907 interventional ones that give a count, is one of 73 that started in 2026, is one of 772 in phase 1, reaches primary completion later than 405 of the 463 other live ones, and was the 2,130th registered.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
Browse Leukemia, Myeloid, Acute studies →312 of the 2,137 studies in Leukemia, Myeloid, Acute with a site in United States are open now. Recruiting first, the newest first:
Uma Borate · Sites in United States
Ages 18+
University of Washington · Sites in United States
Ages 18+
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+
Washington University School of Medicine · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 620 Leukemia, Myeloid, Acute studies recruiting now, 358 (58%) set no upper age limit and 221 (36%) stop at 75 or younger; 145 take children under 18; 28 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,137 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1,078 · Phase 2 970 · Phase 3 139 · Phase 4 7
First in 1986; this study’s year is marked. 73 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 22 is below the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Median enrollment 35 across the 1,907 interventional studies, 98 across the 126 observational. Of the 1,556 that completed or were terminated, 708 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
574 of 2,137 have an industry lead sponsor. The 10 most frequent:
University of Wisconsin, Madison is the lead sponsor of 1,189 studies on the registry; 182 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
University of Wisconsin, Madison has 5 studies filed under Leukemia, Myeloid, Acute — fewer than ten, so there is no comparison to draw.
169 of the studies in Leukemia, Myeloid, Acute with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05183035Phase 3PedAL BCU, LLCVenetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) | 2027-02 |
| NCT05429632Phase 3Priothera SASMocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT | 2027-05 |
| NCT03844048Phase 3AbbVieAn Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial | 2027-08 |
| NCT04256317Phase 3Taiho Oncology, Inc.A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study) | 2027-11-01 |
| NCT03121014University of Illinois at ChicagoStudy of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes | 2026-11 |
Add all 169 to your calendar (.ics) → With an account.
Among the 2,137 studies in Leukemia, Myeloid, Acute with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Participants will receive an infusion of agenT-797 about 7 days after their allogenic SCT.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligible Diagnoses:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks.
Drug: agenT-797
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.
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.
Time frame: Baseline through Day 29 post cell infusion
Number Of Dose-limiting Toxicities
Time frame: Baseline through Day 29 post cell infusion
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)
1-year PFS is the percentage of patients who are alive and whose cancer has not progressed within one year after receiving agenT-797.
Time frame: 12 months
Non-relapse Mortalilty (NRM)
NRM is percentage of patients who died without recurrent or progressive disease after allo-SCT.
Time frame: 12 months
Relapse-free Survival (RFS)
RFS is the length of time from agenT-797 administration until disease relapse or death.
Time frame: 12 months
Overall survival (OS)
OS is the time from agenT-797 administration until death due to any cause.
Time frame: 12 months
Immune reconstitution based on lymphocyte subset panel
Time frame: 12 months
Immunoglobulin levels
Immune reconstitution measured through quantitative 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
Description of type of infection, e.g., bacterial, viral, or fungal.
Time frame: 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).
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)
NRM is percentage of participants who died without recurrent or progressive disease within 100 days after allo-SCT.
Time frame: 100 days
Relapse rate
Relapse rate is percentage of participants who relapsed within 100 days after allo-SCT
Time frame: 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
Time frame: 100 days
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2029, 35 months later.
Of 305 non-industry phase 1 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 87. This study's planned 35 months is below that.
Counting every sponsor, half of 488 studies reached it within 49 months; a quarter within 31 and three quarters within 76.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Allogeneic Invariant Natural Killer T-cells agenT-797
University of Wisconsin, Madison →