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

Overview

About this study

The purpose of this study is to test GC012F, a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/29/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Saurabh Chhabra, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Shaji Kumar, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20563594

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