PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma
18 Years and older, Male and Female
CPHE885B12201 (primary)
NCI-2022-04181
2021-003747-22
Summary
This is a Phase II study to determine the efficacy and safety of PHE885, a BCMA-directed
CAR-T cell therapy, manufactured with a new process. The CAR-T cell therapy will be
investigated as a single agent in relapsed and refractory multiple myeloma
Objectives
This clinical trial employs an open label, single arm, multi-center design with primary
analysis testing overall response rate ( ORR), including one interim analysis for
futility and one interim analysis for efficacy.
The trial population includes adult patients with relapsed and refractory multiple
myeloma (MM) after failure of 3 or more lines of therapy, including failing an
immunomodulatory drug (IMiD), a proteasome inhibitor (PI) and an anti-CD38 (cluster of
differentiation 38) monoclonal antibody (mAb) and who have measurable disease at
enrollment per IMWG criteria . In addition, patients must be refractory to the last line
of therapy
The trial will enroll 90 efficacy evaluable adult patients with relapsed and refractory
MM (efficacy evaluable means participants infused with a PHE885 product at target dose
10e6 that met all release specifications).
Patients will be followed for acute and intermediate safety and efficacy within this
trial for a minimum of 2 years before being transferred to the long-term follow-up trial.
A long-term post-study follow-up for lentiviral vector safety will be offered under a
separate destination protocol for 15 years post injection per health authority
guidelines.
Eligibility
- Inclusion Criteria:
1. â?¥18 years of age at the time of informed consent form (ICF) signature
2. Adult patients after failure of three or more lines of therapy including an IMiD
(e.g., lenalidomide or pomalidomide), a proteasome inhibitor (e.g., bortezomib,
carfilzomib), and an approved anti-CD38 antibody (e.g., daratumumab, isatuximab),
and who have documented evidence of disease progression (IMWG criteria) 3, Must have
received â?¥2 consecutive cycles of treatment for at least three prior regimens unless
deemed refractory to that regimen (i.e., progressive disease as the best response)
4. Must be refractory to the last treatment regimen (defined as progressive disease on
or within 60 days measured from last dose of last regimen).
5. Measurable disease at enrollment as defined by the protocol 6. Eastern Cooperative
Oncology Group (ECOG) performance status that is either 0 or 1 at screening 7. Must
have a leukapheresis material of non-mobilized cells accepted for manufacturing
Exclusion Criteria:
1.Prior administration of a genetically modified cellular product including prior BCMA
CAR-T therapy. 2.Participants who have received prior BCMA -directed bi-specific
antibodies or anti-BCMA antibody drug conjugate.
3. Prior autologous SCT within 3 month or allogenic SCT within 6 months prior to
signing informed consent.
4.Plasma cell (PC) leukemia and other plasmacytoid disorders, other than MM 5.POEMS
syndrome 6.Active central nervous system (CNS) involvement by malignancy 7.Patients with
active neurological autoimmune or inflammatory disorders 8.Inadequate cardiac, renal,
hepatic or hematologic function as defined in the protocol.
Other protocol-defined Inclusion/Exclusion may apply.
Treatment Sites in Georgia
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