About this trial
This is a phase I/II, single-arm, open-lable study of autologous stem cell transplantation in combination with C-CAR088, an autologous BCMA CAR-T cell product, for patients with ulta high-risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features.
Eligibility criteria
Qualifiers
Transplantation eligible patients, male or female, aged 18 to 70 years
Ultra high risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features
Adequate liver, renal, bone marrow, and heart function
Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.
Disqualifiers
Known allergies to the components or excipients of the C-CAR088 cell product
Prior allogenic HSCT, or ASCT
CNS involvement
Stroke or convulsion history within 6 months prior to signing ICF
Trial design
Treatments tested in this trial
- Autologous hematopoietic stem cell transplantation
- C-CAR088
Treatment groups
Sponsors and collaborators
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Shanghai AbelZeta Ltd.
Collaborator