P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)

The study will follow a 3 + 3 design of dose-escalating cohorts. After a patient enrolls,
leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be
sent to a manufacturing site to produce P-BCMA-101 CAR-T cells. The cells will then be
returned to the investigational site and, after a standard chemotherapy based conditioning
regimen, will be administered to the patient. Treated patients will undergo serial
measurements of safety, tolerability and response. Rimiducid may be administered as
indicated.

Inclusion Criteria:

- Males or females, ≥18 years of age

- Must have a confirmed diagnosis of active MM

- Must have measurable MM

- Must have relapsed and/or refractory MM, having received treatment with proteasome
inhibitor and IMiD

- Must have adequate hepatic, renal, cardiac and hematopoietic function

Exclusion Criteria:

- Is pregnant or lactating

- Has inadequate venous access and/or contraindications to leukapheresis

- Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia,
POEMS syndrome, amyloidosis, significant autoimmune, CNS or other malignant disease

- Has an active systemic infection

- Has any psychiatric or medical disorder that would preclude safe participation in
and/or adherence to the protocol

- Has receiving immunosuppressive or other contraindicated therapies within the excluded
time frame from entry

- Has CNS metastases or symptomatic CNS involvement

- Has a history of having undergone allogeneic stem cell transplantation, or any other
allogeneic or xenogeneic transplant