Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around

Description

Summary

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

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 (AZD0120).

For Phase 2, it aims to evaluate the efficacy, to further characterize the safety of GC012F (AZD0120), 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.

Keywords

Relapsed/ Refractory Multiple Myeloma, Multiple Myeloma, BCMA, CAR, Multiple Myeloma, Plasma Cell Neoplasms, GC012F (AZD0120)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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, 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.

  • Adequate bone marrow and organ function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP

You CAN'T join if...

:

  • 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.

Locations

  • Research Site not yet accepting patients
    Los Angeles California 90095 United States
  • Research Site not yet accepting patients
    San Francisco California 94143 United States
  • Research Site accepting new patients
    La Jolla California 92037 United States
  • Research Site accepting new patients
    Phoenix Arizona 85054 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT05850234
Phase
Phase 1/2 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated