PHE885 CAR-T therapy in adult participants with relapsed and refractory multiple myeloma

JRCT ID: jRCT2013220012

Registered date:25/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 15/08/2022
• Target sample size: 8
• Countries of recruitment: France,Japan,Germany,Japan,Italy,Japan,Australia,Japan,Greece,Japan,Singapore,Japan,Spain,Japan
• Study type: Interventional
• Intervention(s): Single infusion of PHE885

Outcome(s)

• Primary Outcome: Stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), stable disease (SD), progressive disease (PD) or unknown (UNK), according to the International Myeloma Working Group (IMWG) criteria.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. >=18 years of age at the time of informed consent form (ICF) signature
2. Adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior 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 have documented evidence of disease progression (IMWG criteria)
3. Must be refractory to the last treatment regimen (defined as progressive disease on or within 60 days measured from last dose of last regimen).
4. Measurable disease at enrollment as defined by the protocol
5. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening
6. Must have a leukapheresis material of non-mobilized cells accepted for manufacturing

Exclude criteria

1. Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. Participants who have received prior BCMA -directed bi-speciific antibodies or anti-BCMA antibody drug conjugate.
2. Prior allogenic stem cell transplantation (SCT) at any time or autologous SCT within 3 months prior to signing informed consent
3. Plasma cell (PC) leukemia and other plasmacytoid disorders, other than MM
4. POEMS syndrome
5. Active central nervous system (CNS) involvement by malignancy
6. Patients with active neurological auto immune or inflammatory disorders

Related Information

• Primary Sponsor: Hirano Takamitsu
• Secondary ID(s): NCT05172596