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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


Primary Investigator
Geer, Marcus
Status
OPEN TO ACCRUAL
Phase
I
II
NCT Number
NCT05850234
UM Number
2025.055
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Bone Marrow Transplant
ID (Protocol)
57239
Secondary Protocol No
HUM00271508
Scope
Unspecified
Sponsor Type
Industry

Disease Site
Multiple Myeloma

Summary
This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.

Eligibility: Inclusion Criteria
  •   * >=18 years of age at the time of consent.
  •   * ECOG performance status of 0 or 1.
  •   * Documented diagnosis of MM per IMWG diagnostic criteria.
  •   * Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
  •   * Have documented evidence of progressive disease per IMWG criteria.
  •   * Participant must have measurable disease at screening.
  •   * Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening.
Exclusion Criteria
  •   :
  •   * Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy.
  •   * Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for >= 2 years. Some exceptions may apply.
  •   * Participant has significant cardiac, neurological, or psychiatric conditions.
  •   * Any other significant medical conditions such as:
    •   * Serious active or uncontrolled infection
    •   * Active autoimmune disease or a history of autoimmune disease within 2 years
    •   * Active plasma cell leukemia at the time of screening
    •   * Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF).
  •   * Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.
  •   Other protocol-defined Inclusion/Exclusion criteria apply.