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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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.
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Gracell Biopharmaceuticals, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Yingda Wen
Principal Investigator Affiliation Gracell Biopharmaceuticals, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed/ Refractory Multiple Myeloma
Additional Details

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, pharmacokinetic characteristics, 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.

Arms & Interventions


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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Colorado Blood and Cancer Institute, Denver, Colorado


Not yet recruiting


Colorado Blood and Cancer Institute

Denver, Colorado, 80218

Icahn School of Medicine at Mount Sinai, New York, New York




Icahn School of Medicine at Mount Sinai

New York, New York, 10029

SCRI Tennessee Oncology, Nashville, Tennessee


Not yet recruiting


SCRI Tennessee Oncology

Nashville, Tennessee, 37203

SAMC South Austin Medical Center, Austin, Texas


Not yet recruiting


SAMC South Austin Medical Center

Austin, Texas, 78745