This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.
For Phase Ib It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, immunogenicity in subjects with relapsed/ refractory Multiple Myeloma, and determine the recommended Phase 2 dose of GC012F (AZD0120). For Phase 2, it aims to evaluate the efficacy, to further characterize the safety of GC012F (AZD0120), pharmacodynamic effect, and immunogenicity, changes from baseline for subject-reported health-related quality of life, overall health status in subjects with relapsed/ refractory Multiple Myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
GC012F (AZD0120) is a BCMA/CD19 dual CAR product under investigation for the treatment of patients with RRMM.
Phase 1b Adverse Events (AEs)
The incidence and severity of adverse events (AEs)
Time frame: 2 years
Phase 1b Dose-limiting toxicities
The DLT evaluation period is defined as the first 28 days of Cycle 1
Time frame: 28 days
Phase 2 Overall response rate (ORR)
Overall response rate (ORR) as defined by the International Myeloma Working Group (IMWG)
Time frame: 2 years
Phase 1b Pharmacokinetic - AUC
Area under the curve of the GC012F (AZD0120) level
Time frame: 2 years
Phase 1b Pharmacokinetic - Cmax
Maximum GC012F (AZD0120) level
Time frame: 2 years
Phase 1b Pharmacokinetic - half-life
The elimination half-life of GC012F (AZD0120) level
Time frame: 2 years
Phase 1b Pharmacokinetic - Tmax
Time to reach Maximum GC012F (AZD0120) level
Time frame: 2 years
Phase 2: Adverse Events (AEs)
Further characterization of the safety of GC012F (AZD0120) by measuring the incidence and severity of AEs
Time frame: 2 years
Phase 1b and 2: Overall Response Rate (ORR)
AstraZeneca Clinical Study Information Center
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Birmingham, Alabama, United States
RECRUITINGResearch Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
La Jolla, California, United States
RECRUITINGResearch Site
Los Angeles, California, United States
NOT_YET_RECRUITINGResearch Site
San Francisco, California, United States
NOT_YET_RECRUITINGResearch Site
Aurora, Colorado, United States
NOT_YET_RECRUITINGResearch Site
Denver, Colorado, United States
RECRUITINGResearch Site
Jacksonville, Florida, United States
NOT_YET_RECRUITINGResearch Site
Miami, Florida, United States
NOT_YET_RECRUITINGResearch Site
Tampa, Florida, United States
RECRUITING...and 27 more locations
ORR (sCR/CR/VGPR) is defined as the proportion of subjects who achieve sCR/CR/VGPR rate according to the IMWG criteria.
Time frame: 2 years
Phase 1b and 2: MRD negative rate
MRD negative rate as defined by the IMWG response criteria
Time frame: 2 years
Phase 1b and 2: Duration of response (DOR)
Duration of response (DOR) will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Time frame: 2 years
Phase 1b and 2: PFS
Progression-free survival (PFS) defined as the time from the date of the initial infusion of GC012F to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Time frame: 2 years
Phase 1b and 2: OS
Overall survival (OS) is measured from the date of the initial infusion of GC012F to the date of the subject's death.
Time frame: 2 years