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

Ichnos Sciences

Status and phase

Enrolling

Phase 1

Conditions

Relapsed/Refractory Multiple Myeloma

Treatments

Drug: ISB 2001

Study type

Interventional

Funder types

Industry

Identifiers

NCT05862012

ISB 2001-101

Details and patient eligibility

About

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).

Full description

The study enrolls participants with R/R MM that have been treated with immunomodulatory drugs (IMiDs), proteasome inhibitors, and anti-CD38 therapies either in combination or as a single agent and are refractory to, or intolerant of, established therapies known to provide clinical benefit in MM.

The study is conducted in two parts: Part 1 dose escalation and Part 2 dose expansion.

Dose escalation continued until the maximum planned dose was reached. Dose expansion cohorts were initiated to further confirm safety and optimal biologically active dose. Participants receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.
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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Part 1: Dose Escalation

Experimental group

Description:

Participants with R/R MM is administered ISB 2001 weekly on Days 1, 8, 15, and 22 of each 28-day cycle, with an additional step-up dose in Cycle 1 on Day 4. Treatment cycle duration is 28 days. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study

Treatment:

Drug: ISB 2001

Part 2: Dose Expansion

Experimental group

Description:

Dose expansion cohorts are initiated to further confirm safety and optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study.

Treatment:

Drug: ISB 2001

Trial contacts and locations

Central trial contact

Ichnos Sciences Clinical Trials Administrator

Data sourced from clinicaltrials.gov

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