Trial Title:
A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma
NCT ID:
NCT05850234
Condition:
Relapsed/ Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Multiple Myeloma, BCMA, CAR
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
GC012F (AZD0120) will be administrated in one infusion
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
GC012F (AZD0120)
Description:
GC012F (AZD0120) is a BCMA/CD19 dual CAR product under investigation for the treatment of
patients with RRMM.
Arm group label:
GC012F (AZD0120)
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Males and females ≥18 years of age at the time of consent
- Written informed consent in accordance with federal, local, and institutional
guidelines
- Have an ECOG performance status of 0 or 1
- Documented diagnosis of MM per IMWG diagnostic criteria
- Received at least three prior MM treatment lines of therapy
- Have received as part of their previous therapy a PI and IMiD and an antiCD38
antibody.
- Have documented evidence of progressive disease by the IMWG criteria.
- Subjects must have measurable disease at screening, as defined by any of the
following: serum monoclonal paraprotein (M-protein) ≥1.0g/dL (10 g/L); urine
M-protein ≥200 mg/24 h; serum FLC assay: involved FLC level is ≥10 mg/dL (100 mg/L)
and serum kappa lambda FLC ratio is abnormal.
- Adequate bone marrow and organ function assessment at screening according to the
hematological, hepatic, and renal parameters listed in the CSP
Exclusion Criteria :
- Diagnosed or treated for invasive malignancy other than multiple myeloma, except:
Malignancy treated with curative intent and with no known active disease present for
≥2 years before enrollment; or
- Adequately treated non-melanoma skin cancer without evidence of disease.
- The following cardiac conditions:
- New York Heart Association (NYHA) stage III or IV congestive heart failure
- Myocardial infarction or coronary artery bypass graft (CABG) ≤6 months prior to
enrollment
- History of clinically significant ventricular arrhythmia or unexplained syncope, not
believed to be vasovagal in nature or due to dehydration
- History of severe non-ischemic cardiomyopathy
- Received either of the following:
- An allogenic stem cell transplant within 6 months before apheresis. Subjects who
received an allogeneic transplant must be off all immunosuppressive medications for
6 weeks without signs of graft-versus-host disease (GVHD).
- An autologous stem cell transplant ≤12 weeks before apheresis
- Known active, or prior history of central nervous system (CNS) involvement or
exhibits clinical signs of meningeal involvement of multiple myeloma.
- Plasma cell leukemia at the time of screening (>2.0×109 /L plasma cells by standard
differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy,
organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL
amyloidosis.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
La Jolla
Zip:
92037
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Austin
Zip:
78704
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Start date:
July 23, 2023
Completion date:
June 5, 2028
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05850234
