ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)

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.

Inclusion Criteria:Transplantation eligible patients, male or female, aged 18 to 65 yearsUltra 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 featuresAdequate liver, renal, bone marrow, and heart functionEastern Cooperative Oncology Group (ECOG) Performance status 0-1.Male and female of reproductive potential must agree to use birth control during the study.Exclusion Criteria:Known allergies to the components or excipients of the C-CAR088 cell productPrior allogenic HSCT, or ASCTCNS involvementStroke or convulsion history within 6 months prior to signing ICFAutoimmune disease, immunodeficiency or disease requiring immunosuppressants treatmentUncontrolled active infection; active HBV, HCV infection; HIV or syphilis InfectionSevere heart, liver, renal or metabolism diseaseInadequate wash-out time for previous anti-tumor treatments prior to apheresisPrevious CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment historyHistory or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial