RECRUITING

A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma

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Conditions

Relapsed/ Refractory Multiple MyelomaMultiple Myeloma, BCMA, CAR

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.

Official Title

A Phase 1b/2 Study of GC012F (AZD0120), a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects With Relapsed/Refractory Multiple Myeloma

Quick Facts

Study Start:2023-07-23
Study Completion:2028-06-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05850234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females ≥18 years of age at the time of consent
  2. * Written informed consent in accordance with federal, local, and institutional guidelines
  3. * Have an ECOG performance status of 0 or 1
  4. * Documented diagnosis of MM per IMWG diagnostic criteria
  5. * Received at least three prior MM treatment lines of therapy
  6. * Have received as part of their previous therapy a PI and IMiD and an antiCD38 antibody.
  7. * Have documented evidence of progressive disease by the IMWG criteria.
  8. * Subjects must have measurable disease at screening, as defined by any of the following: serum monoclonal paraprotein (M-protein) ≥1.0g/dL (10 g/L); urine M-protein ≥200 mg/24 h; serum FLC assay: involved FLC level is ≥10 mg/dL (100 mg/L) and serum kappa lambda FLC ratio is abnormal.
  9. * Adequate bone marrow and organ function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP
  10. * 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
  11. * Adequately treated non-melanoma skin cancer without evidence of disease.
  12. * The following cardiac conditions:
  13. * New York Heart Association (NYHA) stage III or IV congestive heart failure
  14. * Myocardial infarction or coronary artery bypass graft (CABG) ≤6 months prior to enrollment
  15. * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
  16. * History of severe non-ischemic cardiomyopathy
  17. * Received either of the following:
  18. * 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).
  19. * An autologous stem cell transplant ≤12 weeks before apheresis
  20. * Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
  21. * 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35233
United States
Research Site
Phoenix, Arizona, 85054
United States
Research Site
La Jolla, California, 92037
United States
Research Site
Denver, Colorado, 80218
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
New York, New York, 10065
United States
Research Site
Stony Brook, New York, 11794
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Austin, Texas, 78704
United States
Research Site
Dallas, Texas, 75390
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-23
Study Completion Date2028-06-05

Study Record Updates

Study Start Date2023-07-23
Study Completion Date2028-06-05

Terms related to this study

Keywords Provided by Researchers

  • Multiple Myeloma, BCMA, CAR

Additional Relevant MeSH Terms

  • Relapsed/ Refractory Multiple Myeloma