Clinical Trials

Major Inclusion Criteria:

1. Patients ≥18 years of age at the time of signing informed consent

2. Documented RRMM for which no standard therapy options are anticipated to result in a
durable remission. Relapse defined as progressive disease after initial response
(minimal response [MR] or better) to previous treatment, more than 60 days after
cessation of last treatment. Refractory disease defined as <25% reduction in M protein
or progression of disease during treatment or within 60 days after cessation of
treatment.

3. Received at least 3 prior therapies (including proteasome inhibitor, immune modulatory
drug, and an anti-CD38 antibody; patients should not be a candidate for or be
intolerant of all established therapies known to provide clinical benefit in multiple
myeloma).

4. Measurable disease defined as at least one of the following:

1. Serum M-protein ≥0.5 g/dL

2. Urine M-protein ≥200 mg/24 hours

3. Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L) and
an abnormal serum FLC ratio (<0.26 or >1.65)

5. Resolved acute effects of any prior therapy to baseline severity or Common Terminology
Criteria for Adverse Events (CTCAE) version 5.0 Grade ≤1.

Major Exclusion Criteria:

1. Plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma)

2. Patients with only extramedullary relapse of multiple myeloma who do not meet
requirement for measurable disease.

3. Prior autologous peripheral stem cell transplant or prior autologous bone marrow
transplantation within <90 days of the start of study

4. Prior allogeneic stem cell transplantation or solid organ transplantation within 12
months of Screening. However, any patient receiving immunosuppressive medication will
be excluded.

5. History of or known or suspected autoimmune disease (exception(s): patients with
vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism
that is clinically euthyroid at Screening are allowed). Other exceptions may be
allowed following discussion with the Sponsor Medical Monitor for patients who have
not received any treatment for their autoimmune disorder in the past 3 years

6. Second primary malignancy that has not been in remission for greater than 3 years.
Exceptions that do not require a 3-year remission: non-melanoma skin cancer, resected
melanoma in situ, in situ cervical cancer, adequately treated Stage I cancer from
which the subject is currently in remission and has been in remission for ≥2 years,
low-risk prostate cancer with Gleason score <7 and prostate-specific antigen <10 ng/mL

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/31/23. Questions regarding updates should be directed to the study team contact.