Clinical trial · Interventional
agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma
A Phase 1, Open-Label Study of the Safety, Tolerability, and Preliminary Clinical Activity of Allogeneic Invariant Natural Killer T (iNKT) Cells (agenT-797) in Subjects With Relapsed/Refractory Multiple Myeloma
NCT04754100CI-TRIAL-00066946completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in participants with relapsed or refractory multiple myeloma, as well as to define the recommended Phase 2 dose.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
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 (each cycle is 14 days \[2 weeks\]).
- interventionNames
- Drug: agenT-797
Primary outcomes (2)
- measure
- Number Of Participants With Treatment-related Adverse Events
- timeFrame
- Baseline through Day 28 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 14 post cell infusion
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria:
1. Relapsed/Refractory Multiple Myeloma
1. Confirmed diagnosis and evidence of progressive disease or clinical relapse as defined by International Myeloma Working Group criteria and following prior therapy for multiple myeloma (MM)
2. Relapsed or refractory MM requiring current treatment
3. Previously failed ≥ 3 prior regimens (after at least 2 cycles of medication per regimen) and included at least 1 immunomodulatory drug, 1 proteasome inhibitor, and an anti-CD38 antibody agent
4. Participants must have measurable disease as defined by at least 1 of the following:
* Serum M-protein ≥ 0.5 grams/deciliter (dL) by serum protein electrophoresis or for immunoglobulin A (IgA) myeloma, by quantitative IgA; or
* Urinary M-protein excretion at least 200 milligrams (mg)/24 hours; or
* Serum free light chain whereby the involved light chain measures ≥ 10 mg/dL and with an abnormal ratio
2. Estimated life expectancy ≥ 3 months
3. No other medical, surgical, or psychiatric condition (including active substance abuse) that would interfere with compliance to the protocol, as determined by the principal investigator
Key Exclusion Criteria:
1. Concurrent invasive malignancy
2. Participants who had an allogeneic stem cell transplantation and are still on immunosuppressive medications or corticosteroids above physiological dose within 4 weeks before agenT-797
3. Prior radiotherapy within 2 weeks of start of study treatment
4. Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks prior to dose of study drugReferences
Publications (0)
Data not yet available
No reference posted for this study.