ISB 2001 for Multiple Myeloma

Recruiting at 11 trial locations

Overseen By Ichnos Sciences Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ichnos Sciences SA

Disqualifiers: CNS involvement, Uncontrolled infection, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ISB 2001 for people with multiple myeloma, a type of blood cancer, who have not responded to other treatments. The trial aims to determine if ISB 2001 is safe and can help control the cancer. Participants will receive the treatment on specific days over a 28-day cycle, and the trial will explore different doses to find the safest and most effective amount. People with difficult-to-treat multiple myeloma who maintain good overall health might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how ISB 2001 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that ISB 2001 is likely to be safe for humans?

Previous studies have shown that ISB 2001 is safe for people with relapsed or refractory multiple myeloma. Most participants tolerated the treatment without major issues. Common side effects included a manageable immune response called cytokine release syndrome (CRS), which can cause temporary symptoms like fever and tiredness. Importantly, no reports of a serious brain condition called ICANS emerged. Overall, the treatment appears safe for most people and shows promise against multiple myeloma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Unlike the standard treatments for multiple myeloma, which often include drugs like lenalidomide, bortezomib, and dexamethasone, ISB 2001 is unique because it targets the disease differently. Researchers are excited about ISB 2001 because it may offer a new mechanism of action, potentially improving how effectively the cancer is attacked. This treatment is administered weekly, with an additional dose to kickstart the process, which might help manage the disease more aggressively and efficiently than current options. Additionally, ISB 2001 is being evaluated for its safety and optimal dosing, which could further enhance its effectiveness and tolerability for patients.

What evidence suggests that ISB 2001 might be an effective treatment for multiple myeloma?

Research has shown that ISB 2001, the investigational treatment in this trial, offers promising results for relapsed or hard-to-treat multiple myeloma (R/R MM). Studies have found that ISB 2001 effectively kills myeloma cells and aids the immune system in fighting the cancer. In earlier research, 89.5% of patients responded well to the treatment. Additionally, patients generally tolerated it well, with manageable side effects. These findings suggest that ISB 2001 could be a strong option for treating R/R MM. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for people with relapsed/refractory multiple myeloma, meaning their cancer has returned or didn't respond to treatment. They must have measurable signs of the disease and be in relatively good physical condition (ECOG score ≤2). Participants need proper blood, liver, kidney, and heart function to join.

Inclusion Criteria

I can care for myself but may not be able to do heavy physical work.

My blood, liver, kidney, and heart are functioning well.

My multiple myeloma is confirmed and measurable by specific tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants with R/R MM will be 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.

28 days per cycle

Weekly visits

Dose Expansion

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.

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ISB 2001

Trial Overview The study tests ISB 2001's safety and effectiveness against multiple myeloma that's come back or is resistant to other treatments. It's a Phase 1 trial, which means it’s the first time this drug is being tried in humans to see how well it works and what doses are safe.

How Is the Trial Designed?

Group I: Part 2: Dose Expansion Experimental Treatment 1 Intervention

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.

Group II: Part 1: Dose Escalation Experimental Treatment 1 Intervention

Participants with R/R MM will be 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

Who Is Running the Clinical Trial?

Ichnos Sciences SA

Lead Sponsor

Trials

7

Recruited

750+

Citations

1. nature.com nature.com/articles/s43018-024-00821-1

ISB 2001 trispecific T cell engager shows strong tumor ... ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells. Laura ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.7514

Phase 1, first-in-human study of ISB 2001: A ... Conclusions: ISB 2001 was well tolerated with manageable CRS, no ICANS and demonstrated robust anti-myeloma activity in heavily pretreated RRMM ...

3. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/1026/531468/First-Results-of-a-Phase-1-First-in-Human-Dose

First Results of a Phase 1, First-in-Human, Dose Escalation ... We report here first-time data from the early dose-escalation portion of an ongoing, multi-center, single-agent Phase 1 study of ISB 2001.

4. onclive.com onclive.com/view/isb-2001-shows-favorable-safety-profile-and-antitumor-activity-in-r-r-multiple-myeloma

ISB 2001 Shows Favorable Safety Profile and Antitumor ... ISB 2001 showed a manageable safety profile and robust efficacy in relapsed/refractory multiple myeloma patients, with high response rates ...

5. bloodcancerstoday.com bloodcancerstoday.com/post/isb-2001-yields-new-prospects-as-multiple-myeloma-treatment

ISB 2001 Yields New Prospects as Multiple Myeloma ... The overall response rate was 89.5% (n=19) across the effective dose levels and 78% among the nine patients treated with prior T-cell directed ...

6. iginnovate.com iginnovate.com/2025/06/02/igi-asco-isb2001-high-orr-favorable-safety-data/

Full Dose-Escalation Data Show Continued High Response ... Full Dose-Escalation Data Show Continued High Response Rates and Favorable Safety Profile of ISB 2001, a First-in-Class BCMA × CD38 × CD3 ...