A Study of GC012F, a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma

Gracell Biotechnologies

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Relapsed/ Refractory Multiple Myeloma

Treatments

Biological: GC012F

Study type

Interventional

Funder types

Industry

Identifiers

NCT05850234

GC012F-CD19/BCMA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

71 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.