Clinical trial NCT04754100: agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsed/Refractory Multiple Myeloma
Keywords: Multiple myeloma
Immunotherapy
iNKT cells
Lead sponsor: MiNK Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-02-15
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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 drug

Primary outcomes:
measure: Number Of Participants With Treatment-related Adverse Events
timeFrame: Baseline through Day 28 post cell infusion
measure: Number Of Dose-limiting Toxicities
timeFrame: Baseline through Day 14 post cell infusion
Secondary outcomes:
measure: Persistence Of agenT-797 In Peripheral Blood
timeFrame: Baseline/Day 1 (pre-infusion, 5 minutes, 0.25, 0,5, 1, 2, and 4 hours post cell infusion), Days 2, 3, 5, 8, 15, 22, and 29, Weeks 6, 8, and 12, and Months 6, 9, and 12
measure: Overall Response Rate (ORR)
timeFrame: End of study visit (up to 12 months)
measure: Duration Of Response (DOR)
timeFrame: End of study visit (up to 12 months)
measure: Duration Of Clinical Benefit
timeFrame: End of study visit (up to 12 months)
measure: Time To Response (TTR)
timeFrame: End of study visit (up to 12 months)
measure: Measurement Of Serum Alloantibodies To Major Histocompatibility Complex Class I And II
timeFrame: Baseline/Day 1 (pre-infusion), Day 22, Week 6, and end of study visit (up to 12 months)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida
state: Kentucky
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Center
state: Ohio
Study officials:
affiliation: MiNK Therapeutics
name: Medical Director
role: STUDY_DIRECTOR
References: