Health TrialsbyHealthPanel

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

ConditionRelapsed/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIchnos Sciences SA

About this trial

This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma

Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less

Must have adequate hematologic, hepatic, renal, and cardiac functions

Disqualifiers

Active malignant central nervous system involvement

Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1

History of autoimmune disease requiring systemic immunosuppressive therapy

Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ISB 2001

    Drug

    Participants receive escalating doses of ISB 2001

  • ISB 2001

    Drug

    Participants receive injection of ISB 2001 as determined in Part 1.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Part 1: Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)

Time frame
Up to 18 months
2

Number of Dose-Limiting Toxicities (DLT) During the First 28 Days After the First Administration of ISB 2001 (Cycle 1) in Each Cohort (Part 1)

Time frame
Up to 28 days

Secondary outcomes

1

Maximum Concentration (Cmax) of ISB 2001 in Serum

Time frame
Up to 28 days
2

Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum

Time frame
Up to 28 days
3

Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum

Time frame
Up to 28 days
4

Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum

Time frame
Up to 28 days

Other outcomes

Sponsors and contacts

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

Ichnos Sciences SA

Lead sponsor

Source ClinicalTrials.gov
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