AGENT-797 in Patients With Relapsed/Refractory Multiple Myeloma

Overview

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.

SparkCures ID 1123
Trial Phase Phase 1
Enrollment 30 Patients
Treatments
  • agenT-797
Tags
  • Natural Killer (NK) Cells (Allogeneic)
Trial Sponsors
  • AgenTus Therapeutics, Inc.
NCT Identifier

NCT04754100

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Written informed consent obtained prior to any screening procedures and in accordance with federal, local, and institutional guidelines.
  • Age ≥ 18 years.
  • Confirmed diagnosis, and evidence of progressive disease or clinical relapse as defined by International Myeloma Working Group (IMWG) criteria and following prior therapy for MM:
    1. Relapsed or refractory MM requiring current treatment.
    2. Previously failed ≥ 3 prior regimens.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
  • Estimated life expectancy ≥ 4 months.
  • 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.
  • Female subjects of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at Screening, and male subjects must use an effective barrier method of contraception if sexually active with a female of childbearing potential.
  • Subjects need a functioning, central venous access in place for the administration of agenT-797.

Exclusion Criteria:

  • Pregnant or nursing women.
  • Prior history of invasive malignancy.
  • Subjects who had an allogeneic stem cell transplantation and are still on immunosuppressive medications or corticosteroids above physiological dose.
  • New York Heart Association Class III or IV heart failure, unstable angina, or a history of recent myocardial infarction.
  • Adverse events from prior anticancer therapy that have not resolved to NCI CTCAE Grade ≤ 1.
  • Receiving any investigational products within 4 weeks or 5 half-lives of cell infusion.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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