C-CAR088 治疗复发/难治性多发性骨髓瘤患者的研究

Inclusion Criteria

* ≥ 18 years of age, male or female patients
* Relapsed or refractory multiple myeloma
* Have been treated with ≥ 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug, and had progressed during or within 12 months post the last treatment.
* Had measurable disease as defined by any of the following criteria:

  * Serum M protein ≥ 0.5g/dL
  * Urine M protein ≥ 200mg/24h
  * Serum free light chain (sFLC): abnormal κ/λ ratio with involved sFLC ≥ 100mg/L
* Adequate liver, renal, bone marrow, and heart function
* Eastern cooperative oncology group (ECOG) 0-1

Exclusion Criteria

* Any known allergies to the components or excipients of the C-CAR088 cell product
* Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or autologous stem-cell transplantation (ASCT) within 12 weeks prior to apheresis
* Central nervous system (CNS) involvement
* Stroke or convulsion history within 6 months prior to signing informed consent form (ICF)
* Plasma leukemia
* Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment
* Uncontrolled active infection; active hepatitis B virus (HBV), hepatitis C virus (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

主要终点：[phase Ib] Incidence and severity of Adverse Events · Incidence and severity of Adverse Events · 24 months；[phase II] Overall response rate (ORR) at 3 months after C-CAR088 infusion · the rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion · 3 months
次要终点：Overall response rate (ORR)；[phase Ib] Overall response rate (ORR) at 3 months after C-CAR088 infusion；Duration of response (DOR)；Time to response (TTR)；Progression-free survival (PFS)；Overall survival (OS)；Minimal residual disease (MRD) negativity rate；[phase II] Incidence and severity of Adverse Events

• C-CAR088 · EXPERIMENTAL · Autologous C-CAR088 administered by intravenous (IV) infusion

This is a multicenter, open-label study to evaluate the safety and efficacy of C-CAR088 in patients with relapsed or refractory multiple myeloma. The phase Ib part of this study is to determine the recommended phase 2 dose (RP2D) of C-CAR088 in the targeted patient population.