AGENT-797 in Patients With Relapsed/Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT04754100|
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : May 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Multiple Myeloma||Drug: agenT-797||Phase 1|
This is a Phase I, open-label, dose-escalation, single arm study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in subjects with relapsed/refractory MM, as well as define the RP2D.
In Part 1, the study will employ a standard 3+3 dose escalation design, for which 3 to 6 evaluable subjects (maximally 9 if recommended by the Safety Review Committee [SRC]) will be enrolled at each assigned dose level, per cohort depending on the occurrence of DLTs.
Part 2 will consist of one or more cohorts of in total up to around 6 to 12 subjects with relapsed/refractory MM who receive agenT-797 at a given dose after lymphodepletion and will employ a 3+3 dose escalation/de-escalation design depending on the occurrence of DLTs. The starting dose in Part 2 will be equal to the maximum tolerated dose (MTD) defined in Part 1 in the absence of any DLTs at that dose level. If a DLT is observed at the MTD in Part 1, the starting dose level in Part 2 will be the dose level below MTD.
Details of the analyses will be described in a statistical analysis plan.
A Safety Monitoring Committee will be established to assess safety and decide on escalation to next Cohort.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Open-Label Study of the Safety, Tolerability and Preliminary Clinical Activity of Allogeneic Invariant Natural Killer (iNKT) Non-transduced Cells (agenT-797) in Patients With Relapsed/Refractory Multiple Myeloma|
|Actual Study Start Date :||March 29, 2021|
|Estimated Primary Completion Date :||April 15, 2022|
|Estimated Study Completion Date :||April 15, 2023|
Experimental: Dosage and Cohorts
Part 1: Dose escalation without lymphodepletion.
Dosage Frequency and Mode of Administration: agenT-797 will be administered to subjects as a single IV infusion.
Part 2: Dose escalation with lymphodepletion (optional)
Dosage Frequency and Mode of Administration: Subjects will receive lymphodepletion before infusion of agenT-797. Starting dose will be defined based on data from Part 1.
Part 1 agenT-797 is an off-the shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex-vivo.
Part 2 agenT-797 is an off-the shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex-vivo.
The conditioning therapy will be administered prior to agenT-797 infusion. Dose and rate of infusion of the chemotherapy may be adapted as medically indicated.
- Incidence of AEs [ Time Frame: Up to day 28 post cell infusion. ]Number of participants with treatment-related AEs as determined per NIC CTCAE v5.0
- Correlation of the dose of iNKT cell therapy with the incidence, nature, and intensity of AEs. [ Time Frame: Up to day 28 post cell infusion. ]Evaluation of AEs at each dose level.
- Recommended Phase 2 dose [ Time Frame: 28 days post cell infusion ]Maximum Tolerated Dose (MTD) based on DLT occurence at DLT period (28 days after cell infusion).
- Persistence of allogeneic iNKT cells. [ Time Frame: Baseline, 2 hours post cell infusion, and on Days 2, 3, 5, 8, 15, 22, and 29, Weeks 6, 8, and 12, and Months 6, 9, and 12. ]Persistence of agenT-797 in peripheral blood (SNP-based assay)
- Clinical response evaluation. [ Time Frame: End of study visit (up to 12 months). ]Evaluation using the International Myeloma Working Group (IMWG) consensus criteria.
- Evaluation of immune response to donor cells [ Time Frame: Baseline, Day 22, Week 6 and end of study visit (up to 12 months). ]Measurement of serum alloantibodies to MHC Class I and II
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754100
|Contact: Agenus, Inc. Clinical Trial Informationemail@example.com|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Clifton Mo, MD Clifton_Mo@DFCI.HARVARD.EDU|
|Principal Investigator: Clifton Mo, MD|
|Study Director:||Medical Director||AgenTus Therapeutics, Inc.|