Tests C-CAR088 cell therapy in relapsed or refractory multiple myeloma
Tests C-CAR088, a BCMA-targeted CAR-T cell therapy, in adults with multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 1/2
Where in China
- Institute of Hematology and Blood Diseases HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai AbelZeta Ltd.
- Trial code
- NCT05521802
- Record updated
- 24 March 2023
- Original description
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.Read full original descriptionShow less
A Phase Ib/II Study of CBM.BCMA Chimeric Antigen Receptor T Cell Product (C-CAR088) for Treating Patients With Relapsed or Refractory Multiple Myeloma
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.
Inclusion: ≥ 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: Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or autologous stem-cell transplantation (ASCT) within 12 weeks prior to apheresis; Stroke or convulsion history within 6 months prior to signing informed consent form (ICF); 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; Any known allergies to the components or excipients of the C-CAR088 cell product; 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; 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; Central nervous system (CNS) involvement; Plasma leukemia.