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

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ClinicalTrials.gov Identifier: NCT05850234
Recruitment Status : Recruiting
First Posted : May 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
Gracell Biopharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Relapsed/ Refractory Multiple Myeloma Biological: GC012F Phase 1 Phase 2

Detailed 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, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: GC012F will be administrated in one infusion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 20, 2023
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Phase 1b Adverse Events (AEs) [ Time Frame: 2 years ]
    The incidence and severity of adverse events (AEs)

  2. Phase 1b Dose-limiting toxicities [ Time Frame: 28 days ]
    The DLT evaluation period is defined as the first 28 days of Cycle 1

  3. Phase 2 Overall response rate (ORR) [ Time Frame: 2 years ]
    Overall response rate (ORR) as defined by the International Myeloma Working Group (IMWG)


Secondary Outcome Measures :
  1. Phase 1b Pharmacokinetic - AUC [ Time Frame: 2 years ]
    Area under the curve of the GC012F level

  2. Phase 1b Pharmacokinetic - Cmax [ Time Frame: 2 years ]
    Maximum GC012F level

  3. Phase 1b Pharmacokinetic - half-life [ Time Frame: 2 years ]
    The elimination half-life of GC012F level

  4. Phase 1b Pharmacokinetic - Tmax [ Time Frame: 2 years ]
    Time to reach Maximum GC012F level

  5. Phase 2: Adverse Events (AEs) [ Time Frame: 2 years ]
    Further characterization of the safety of GC012F by measuring the incidence and severity of AEs

  6. Phase 1b and 2: Overall Response Rate (ORR) [ Time Frame: 2 years ]
    Overall response rate (ORR) is defined as the proportion of subjects who achieve a PR or better according to the IMWG criteria.

  7. Phase 1b and 2: Duration of response (DOR) [ Time Frame: 2 years ]
    Duration of response (DOR) will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.

  8. Phase 1b and 2: PFS [ Time Frame: 2 years ]
    Progression-free survival (PFS) defined as the time from the date of the initial infusion of GC012F to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.

  9. Phase 1b and 2: OS [ Time Frame: 2 years ]
    Overall survival (OS) is measured from the date of the initial infusion of GC012F to the date of the subject's death.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05850234


Contacts
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Contact: Grace Hong, MD 713-231-8670 grace.hong@gracellbio.com

Locations
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United States, Colorado
Colorado Blood and Cancer Institute Not yet recruiting
Denver, Colorado, United States, 80218
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, Tennessee
SCRI Tennessee Oncology Not yet recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
SAMC South Austin Medical Center Not yet recruiting
Austin, Texas, United States, 78745
Sponsors and Collaborators
Gracell Biopharmaceuticals, Inc.
Investigators
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Study Director: Yingda Wen Gracell Biopharmaceuticals, Inc.
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Responsible Party: Gracell Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05850234    
Other Study ID Numbers: GC012F-CD19/BCMA-001
First Posted: May 9, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases