RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

The Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation (ASCT) in Combination With C-CAR088, an Autologous BCMA CAR-T Cell Product, for Treating Patients With Ultra High-risk Multiple Myeloma

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Transplantation eligible patients, male or female, aged 18 to 65 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. - Male and female of reproductive potential must agree to use birth control during the study. Who Should NOT Join This Trial: - 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 - autoimmune conditions (where your immune system attacks your own body), weakened immune system or disease requiring immunosuppressants treatment - Uncontrolled active infection; active HBV, HCV infection; HIV or syphilis Infection - Severe heart, liver, renal or metabolism disease - Inadequate wash-out time for previous anti-tumor treatments prior to apheresis - Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history - History 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Transplantation eligible patients, male or female, aged 18 to 65 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. * 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 product * Prior allogenic HSCT, or ASCT * CNS involvement * Stroke or convulsion history within 6 months prior to signing ICF * Autoimmune disease, immunodeficiency or disease requiring immunosuppressants treatment * Uncontrolled active infection; active HBV, HCV infection; HIV or syphilis Infection * Severe heart, liver, renal or metabolism disease * Inadequate wash-out time for previous anti-tumor treatments prior to apheresis * Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history * History 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

Treatments Being Tested

PROCEDURE

Autologous hematopoietic stem cell transplantation

Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection. If previously collected stem cells are available, no stem cell mobilization or collection is required, and patients will receive conditioning directly.

BIOLOGICAL

C-CAR088

C-CAR088 is an BCMA targeted Chimeric Antigen Receptor-T cell product. Patients will receive C-CAR088 single dose infusion 3 days after ASCT. The dose level of C-CAR088 will be determined by the investigator.

Locations (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China