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NCT05862012 | RECRUITING | Relapsed/Refractory Multiple Myeloma

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

Ichnos sciences in

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).

Condition or disease

Relapsed/Refractory Multiple Myeloma

Intervention/treatment

ISB 2001

ISB 2001

Phase

PHASE1

Detailed Description:

The study will enroll 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 will be conducted in two parts: * Part 1: Dose escalation * Part 2: Dose expansion Dose escalation will continue until either the maximum tolerated dose (MTD) is defined, the maximum planned dose is reached, or a recommended phase 2 dose (RP2D) is selected. Dose expansion cohorts will be 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-11-01
Estimated Primary Completion Date : 2027-07
Estimated Study Completion Date : 2027-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Location Details

NCT05862012

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Standford Cancer Institute

Palo Alto, California, United States, 94304

RECRUITING

United States, New York

Montefiore Medical Center

Bronx, New York, United States, 10467

RECRUITING

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

RECRUITING

Australia, New South Wales

Concord Hospital

Concord, New South Wales, Australia, 2139

RECRUITING

Australia, Queensland

Pindara Private Hospital

Benowa, Queensland, Australia, 4217

RECRUITING

Australia, Victoria

St. Vincent's Hospital Melbourne

Fitzra, Victoria, Australia, 3065

RECRUITING

Australia, Victoria

Peter MacCallum Cancer Center

Melbourne, Victoria, Australia, 3000

RECRUITING

Australia, Western Australia

Linear Clinical Research

Nedlands, Western Australia, Australia, 6009

RECRUITING

India,

HCG Hospital

Bangalore, India,