A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

The purpose of this study is to assess the safety, tolerability, preliminary efficacy, cellular kinetics, and other exploratory endpoints of AZD4045 as a monotherapy and in association with daratumumab and aldesleukin for the treatment of adult participants with RRMM.

Eligibility criteria

Qualifiers

Participant must be 18 years or older at the time of signing the informed consent form.

Participants must have documented diagnosis of MM according to the IMWG diagnostic criteria.

Serum M-protein level ≥ 1.0 g/dL.

Urine M-protein ≥ 200 mg/24 h.

Disqualifiers

Participant has a history of any grade IEC-HS and/or history of Grade ≥ 3 CRS and/or Grade ≥ 2 neurotoxicities during prior CAR-T cell therapy or T cell engaging therapy.

Participant has ongoing toxicity from previous anti-cancer therapy that did not resolve to baseline levels or to Grade ≤ 1 with the exception of alopecia or peripheral neuropathy.

Participant has a known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.

Participant has systemic immunoglobulin light chain amyloidosis, active plasma cell leukaemia (presence of ≥ 5% of circulating plasma cells on a conventional peripheral blood smear) at time of screening, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.

Trial design

Treatments tested in this trial

  • AZD4045
  • Daratumumab
  • Aldesleukin

Treatment groups

101 Participants
are divided into 2 treatment groups

Sponsors and collaborators