A PHASE 1 OPEN-LABEL STUDY OF THE SAFETY, TOLERABILITY AND PRELIMINARY CLINICAL ACTIVITY OF ALLOGENEIC INVARIANT NATURAL KILLER T (INKT) (AGENT-797) IN SUBJECTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

NOT ENROLLING
Protocol # :
20-395
Conditions
Relapsed/Refractory Multiple Myeloma
Phase
I
Disease Sites
Multiple Myeloma
Principal Investigator
Mo, Clifton, C.
Site Research Nurses
Coleman, Kimberly, C.
Hogan, Sarah
Kendricken, Elizabeth
O'Brien, Alexandra

Trial Description

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 Requirements

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

20-395