What's the purpose of this trial?
This trial is a phase 1, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CAR T-cell therapy, in early-line treatment in subjects with Multiple Myeloma.
This trial is currently open and accepting patients.
What will happen during the trial?
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
required.
Inclusion Criteria:
* Males and females ≥18 years of age at the time of consent
* Documented diagnosis of multiple myeloma (MM) per IMWG diagnostic criteria
* Have an ECOG performance status of 0 or 1
* Documented diagnosis of MM per IMWG diagnostic criteria
* Subjects must have measurable disease per IMWG criteria, defined as:
* Serum monoclonal paraprotein (M-protein) ≥1.0 g/dL (10 g/L)
* Urine M-protein ≥200 mg/24 h
* Serum free light chain (FLC) assay: involved FLC level is ≥10 mg/dL (100 mg/L) and serum kappa lambda FLC ratio is abnormal
* Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the clinical trial protocol
* Patients with a previously treated malignancy other than MM if treatment of that malignancy was completed greater than 2 years before screening and the patient has no evidence of disease at the time of screening
For NDMM subjects:
* Newly diagnosed multiple myeloma (NDMM) without prior anti-myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable) \* Induction therapy: bortezomib based triplet regimen, with or without anti-CD38 antibody, such as VRD Bortezomib/Lenalidomide/Dexamethasone, DVRd-Daratumumab/lenalidomide/bortezomib/dexamethasone, etc., as NCCN Guidelines preferred or recommended standard of care therapies, which is determined by the investigator based on the patient's condition
* Classified as high-risk MM
For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) subjects:
* Have received and failed 1 or 2 lines of anti-myeloma therapy
* Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy
* Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen
Exclusion Criteria:
* Have received prior treatment with CAR T therapy directed at any target
* Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
* Stroke or seizure within 6 months of signing informed consent
* Active or history of plasma cell leukemia at the time of screening
* Seropositive for human immunodeficiency virus (HIV)
* Active Hepatitis B
* Hepatitis C infection
* Serious underlying medical condition, such as:
* Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection
* Active autoimmune disease or a history of autoimmune disease within 3 years
* Overt clinical evidence of dementia or altered mental status
Additional Trial Information
Phase 1
Enrollment: 20 patients (estimated)
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