This is a Phase 1b open-label, multicenter, non-randomized study of GC012F, a CD19/BCMA dual CAR T cell therapy, in adult participants with relapsed/refractory AL amyloidosis.
This is a Phase 1b, open-label, multicenter, non-randomized study to evaluate the safety, tolerability, and efficacy of GC012F in adult participants with relapsed/refractory AL amyloidosis. A single-arm design was chosen for the study due to the absence of approved therapies for use as a concurrent control for this patient population. In the study, the safety of different doses of GC012F will be evaluated and the RP2D will be selected based on the totality of clinical safety, preliminary efficacy, CK and PD data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
The investigational agent, GC012F, is an autologous BCMA/CD19 dual directed CAR product under investigation for the treatment of patients with RRMM, ELMM, SLE, and B NHL.
Research Site
Beijing, China
NOT_YET_RECRUITINGResearch Site
Beijing, China
NOT_YET_RECRUITINGResearch Site
Beijing, China
Number of Participants With incidence and severity of Treatment-emergent Adverse Events
Time frame: Through study completion, an average of 2 years
Proportion of Participants Experiencing a Complete Response
Time frame: Through study completion, an average of 2 years
Levels of AZD0120 in blood over time in participants with AL amyloidosis
Time frame: Through study completion, an average of 2 years
Percentage of participants achieving hematologic response
Time frame: Through study completion, an average of 2 years
AstraZeneca Clinical Study Information Center
CONTACT
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Research Site
Changchun, China
RECRUITINGResearch Site
Guangzhou, China
NOT_YET_RECRUITINGResearch Site
Hangzhou, China
NOT_YET_RECRUITINGResearch Site
Suzhou, China
RECRUITINGResearch Site
Wenzhou, China
RECRUITINGResearch Site
Wuhan, China
NOT_YET_RECRUITING