A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai AbelZeta Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
≥ 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.
Serum M protein ≥ 0.5g/dL
Disqualifiers
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)
Trial design
Treatments tested in this trial
- B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell
Treatment groups
92 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov