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

ID#: NCT05850234

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: July 20, 2023

End Date: June 01, 2026

Contact Information:
Grace Hong, MD
Summary: 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.

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.

- Adequate bone marrow and organ function

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.