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Clinical Trials/CTRI/2024/04/065728
CTRI/2024/04/065728
Recruiting
Phase 1

A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects with Relapsed/Refractory Multiple Myeloma. - NI

Ichnos Sciences SA0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C900- Multiple myeloma

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Health Condition 1: C900- Multiple myeloma
Sponsor
Ichnos Sciences SA
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Participants with pathologically confirmed MM with measurable M\-protein: serum and/or 24\-hour urine, serum\-free light chains or measurable isolated plasmacytoma.
  • •2\. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
  • •3\. Must have adequate hematologic, hepatic, renal, and cardiac functions.

Exclusion Criteria

  • •1\. Active malignant central nervous system involvement
  • •2\. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
  • •3\. History of autoimmune disease requiring systemic immunosuppressive therapy
  • •4\. 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.
  • •5\. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001\.

Outcomes

Primary Outcomes

Not specified

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