Relapsed/Refractory Multiple Myeloma Multiple Myeloma, Relapsed, Refractory
Conditions
Interventions
Apheresis, Bridging Therapy, Lymphodepleting Chemotherapy, Eque-cel infusion
Sponsors
Nishimura Hideo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, male or female. 2.Patients with a confirmed diagnosis of relapsed/refractory multiple myeloma according to the IMWG diagnostic criteria. 3. Patients who have received at least three prior treatment regimens (including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibody-based chemotherapy regimens) and have documented disease progression during or within 12 months of their most recent anti-myeloma treatment. 4.Patients with measurable disease at screening, as determined by any of the following criteria: - Serum M-protein level: IgG type M-protein level 10 g/L or more, IgA, IgD, IgE, IgM type M-protein level 5 g/L or more - Urinary M-protein level 200 mg/24 hours or more. -Light-chain multiple myeloma without measurable M protein in serum or urine: involved serum free light chain 100 mg/L or more with an abnormal serum kappa / lambda free light chain ratio. 5.ECOG PS 0 or 1.
Exclusion criteria
Exclusion criteria: 1. Patients with graft-versus-host disease (GVHD) or requiring long-term use of immunosuppressants. 2. Patients with a history of BCMA-targeted therapy. 3. Patients who have undergone autologous hematopoietic stem cell transplantation (auto-HSCT) within 12 weeks prior to apheresis, two auto-HSCTs, or prior allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: 1) Safety endpoint (Part1) - Incidence and severity of adverse events(based on NCI-CTCAE v5.0) - Incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS based on the 2019 ASTCT criteria) - Changes in clinical laboratory results 2) Efficacy endpoint (Part 2): - Independent Review Committee (IRC)-assessed ORR: ORR in all subjects at the time the last subject completed the 6-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: Efficacy endpoint(International Myeloma Working Group (IMWG) 2016 criteria): - Investigator-assessed overall response rate (ORR): ORR for all subjects at the time the last subject completed the 6-month follow-up. - IRC- and investigator-assessed ORR: Rate of best response (PR, very good PR, CR, sCR) within 1 month, 3 months, and 6 months after Eque-cel infusion. - IRC and investigator-assessed duration of response (DOR): The period from the first response (PR, VGPR, CR, sCR) to the date of the first documented evidence of disease progression or death from any cause, as defined by the IMWG criteria after treatment. - IRC and investigator-assessed time to response (TTR): The period from Eque-cel infusion to the date of the first documented response (PR or better). - IRC and investigator-assessed time to complete response (TTCR): The period from Eque-cel infusion to the date of complete response (CR) or stringent complete response (sCR). - Minimal residual disease (MRD) assessmentby flow cytometry: The proportion of subjects achieving MRD negativity and the duration of MRD negativity. - IRC and investigator-assessed progression-free survival (PFS): The period from Eque-cel infusion to the date of first disease progression or death from any cause. - Overall survival (OS): The period from Eque-cel infusion to death from any cause. - PK endpoints: Maximum concentration (Cmax) of BCMA CAR-T cells and lentiviral vector copy number (VCN) expanded in peripheral blood after Eque-cel infusion, time to Cmax (Tmax), area under the curve (AUC) from days 0-28 (AUC0-28d), AUC from days 0-90 (AUC0-90d), and AUC from day 0 to the last PK measurement (AUC0-last). - PD endpoints: Circulating soluble BCMA (sBCMA) in peripheral blood, and concentrations of the immune-related inflammatory cytokines C-reactive protein (CRP), interleukin-6 (IL-6), and ferritin at each time point. | — |
Contacts
Public ContactHaibo Wang
International Cooperation for Medical Innovation Co.,Ltd.
Outcome results
None listed