Clinical trial · Interventional
Allogeneic iNKT Cell Therapy (agenT-797) After SCT
UW26004: Phase I Trial of Allogeneic iNKT Cell Therapy (agenT-797) in Patients Undergoing Allogeneic Hematological Stem Cell Transplantation (SCT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Allogenic Stem Cell Transplantation | — | UNRESOLVED | — |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Lymphoid Malignancies | — | UNRESOLVED | — |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myeloid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| agenT-797 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Allogeneic iNKT Cells
- description
- 3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks.
- interventionNames
- Drug: agenT-797
Primary outcomes (2)
- measure
- Number Of Participants With Treatment-related Adverse Events
- timeFrame
- Baseline through Day 29 post cell infusion
- description
- This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
- measure
- Number Of Dose-limiting Toxicities
- timeFrame
- Baseline through Day 29 post cell infusion
Secondary outcomes (15)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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: * 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 Exclusion Criteria: * Excluded Diagnoses: Primary Myelofibrosis in the dose escalation phase and could be included in the dose-expansion phase
References
Publications (0)
Data not yet available