Recruiting
Phase 1

ISB 2001

Sponsor:

Ichnos Sciences SA

Code:

NCT05862012

Conditions

Relapsed/Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ISB 2001

ISB 2001

Study Details

Brief summary:

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).

Conditions

Relapsed/Refractory Multiple Myeloma

Study ID

NCT05862012

Start date

Nov 1, 2023

Status verified date

Mar, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Dose Escalation

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

experimental: Part 2: Dose Expansion

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.

Interventions

ISB 2001

Participants receive escalating doses of ISB 2001

ISB 2001

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

Primary outcome measure

  • Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 18 months ]
  • 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 ]

Central Contacts and Locations

Central contacts

Ichnos Sciences Clinical Trials Administrator

(315) 583-1249clinicaltrials@ichnossciences.com

Locations

Standford Cancer Institute

Recruiting

Palo Alto, California, United States, 94304

Contacts

Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Froedtert Hospital & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

More Information

Sponsor

Ichnos Sciences SA

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • ISB 2001
  • Relapsed/refractory multiple myeloma
  • Open-label
  • Dose escalation
  • Dose expansion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ichnos Sciences SA on 2026-04-01.