Clinical Trial 23912

• Overview

  Study Title:

  A Modular, Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120, a Dual-targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD-19 in Participants with Multiple Myeloma

  Summary:

  This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).

  Objective:

  Primary (Dose escalation Phase 1): *To assess the safety and tolerability of AZD0120 in participants with ELMM and with NDMM *To determine the RP2D of AZD0120 in participants with ELMM and with NDMM Secondary: *To characterize the PK of AZD0120 in peripheral blood by ddPCR in participants with ELMM and with NDMM *To evaluate the efficacy of AZD0120 in participants with ELMM and with NDMM *To assess the humoral immunogenicity of AZD0120 in participants with ELMM and with NDMM

• Treatments

  Therapies:

  Cell Therapy; Chemotherapy (NOS); Immunostimulatory

  Medications:

  AZD0120 (); CC-5013 (Lenalidomide); Lenalidomide (Revlimid); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

• Inclusion Criteria

  Key Inclusion Criteria:
  • Males and females ≥18 years of age at the time of consent.
  • Participant must have documented diagnosis of MM per IMWG diagnostic criteria.
  • ECOG performance status of 0 or 1.
  • Adequate organ and bone marrow function.
  • Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable).
  • For participants on Module 2: Newly diagnosed MM with a maximum of 6 cycles and minimum of 4 cycles of induction therapy completed prior to screening.
  • Classified as high-risk MM.
  • Have received and failed 1 or 2 lines of anti-myeloma therapy.
  • Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy.
  • Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Have received prior treatment with CAR T therapy directed at any target.
  • Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
  • Active or history of plasma cell leukemia at the time of screening.
  • Seropositive for human immunodeficiency virus (HIV).
  • Active Hepatitis B infection.
  • Active Hepatitis C infection.
  • Serious underlying medical condition.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.