Purpose

This trial is a phase 1b/2, open-label, multicenter study of GC012F, a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
GC012F will be administrated in one infusion
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GC012F
GC012F will be administrated in one infusion
  • Biological: GC012F
    GC012F is a BCMA/CD19 dual CAR product under investigation for the treatment of patients with RRMM.

Recruiting Locations

UAB University of Alabama
Birmingham, Alabama 35233

More Details

Status
Recruiting
Sponsor
Gracell Biopharmaceuticals, Inc.

Study Contact

Grace Hong, MD
713-231-8670
grace.hong@gracellbio.com

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. For Phase 2, it aims to evaluate the efficacy, to further characterize the safety of GC012F, 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.