PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma
18 Years and older, Male and Female
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
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.
- Inclusion Criteria:
1. =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 =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
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
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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials