A Phase 1b/2 Study of GC012F, a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects With Relapsed/Refractory Multiple Myeloma GCO12F CAR-T

What's the purpose of this trial?

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.

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
* 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.

Additional Trial Information

Phase 1/2

Enrollment: 68 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Colorado

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Not Yet Accepting

New York

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Not Yet Accepting

Texas

South Austin Cancer Center

Austin, TX

Not Yet Accepting
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