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

ConditionRelapsed or Refractory Multiple Myeloma
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • AZD4045

    Biological/Vaccine

    Allogeneic Chimeric Antigen Receptor T cell (CAR-T) Therapy Targeting B Cell Maturation Antigen (BCMA)

  • Daratumumab

    Drug

    Anti-CD38 monoclonal antibody

  • Aldesleukin

    Drug

    Recombinant human IL-2

Treatment groups

101 Participants
are divided into 2 treatment groups
Group A: Module 1: AZD4045 monotherapyExperimental treatment 1 intervention
Group B: Module 1: AZD4045 in association with daratumumab and aldesleukinExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse events (AEs) and serious AEs (SAEs)

Incidence and severity of adverse events (AEs) and serious AEs (SAEs)

Time frame
Through study completion, an average of 2 years
2

Dose-limiting toxicities (DLT)

Incidence and severity of dose-limiting toxicity (DLT) events

Time frame
28 days

Secondary outcomes

1

Efficacy - Objective Response Rate (ORR)

Defined as proportion of participants who achieve an overall response of PR or better according to the IMWG 2016 criteria

Time frame
Through study completion, an average of 2 years
2

Efficacy - Complete Response Rate (CRR)

Defined as proportion of participants who achieve a CR/sCR response according to the to the IMWG 2016 criteria

Time frame
Through study completion, an average of 2 years
3

Efficacy - Duration of Response (DOR)

Defined as the time from first documented confirmed response until date of documented PD per IMWG 2016 criteria or death due to any cause, whichever occurs first

Time frame
Through study completion, an average of 2 years
4

Efficacy - Time to Response (TTR)

Defined as the time from infusion until the date of first documented objective response, as assessed per IMWG 2016 criteria

Time frame
Through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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