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Monoclonal Antibodies

ISB 1342 for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by Ichnos Sciences SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented diagnosis of multiple myeloma with measurable disease per International Myeloma Working Group (IMWG) criteria, including non-secretory or oligo-secretory multiple myeloma which has relapsed after or is refractory to prior therapies, including proteasome inhibitors (PIs), immunomodulators (IMiDs) and anti-CD38 targeted therapies (daratumumab, isatuximab)

Left ventricular ejection fraction (LVEF) ≥50% and no pericardial or pleural effusion at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from first dose until death from any cause or end of study collection, whichever is later, assessed up to 60 months.

Awards & highlights

Study Summary

This trial is testing a new drug for people with a certain type of cancer that has come back or didn't respond to other treatments. They want to see if it is safe and works well.

Who is the study for?

This trial is for people with multiple myeloma that's come back or didn't respond to treatments like proteasome inhibitors, immunomodulators, and anti-CD38 therapies. Participants should be in relatively good health based on ECOG scores, have no serious heart or lung issues, and test negative for hepatitis B & C and HIV.Check my eligibility

What is being tested?

The study tests ISB 1342, a CD38/CD3 bispecific antibody designed to target cancer cells in those with relapsed/refractory multiple myeloma. It aims to evaluate the treatment's safety, effectiveness, how it interacts with the body (PK/PD), and if it causes any immune reactions.See study design

What are the potential side effects?

While specific side effects of ISB 1342 are not listed here, similar cancer treatments often cause fatigue, nausea, infection risk increase; potential allergic reactions; blood count changes; liver or kidney function alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My multiple myeloma has returned or didn't respond to treatments including PIs, IMiDs, and anti-CD38.

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My heart pumps well and I don't have fluid around my heart or lungs.

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I am mostly self-sufficient but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from first dose until death from any cause or end of study collection, whichever is later, assessed up to 60 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from first dose until death from any cause or end of study collection, whichever is later, assessed up to 60 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first dose until death from any cause or end of study collection, whichever is later, assessed up to 60 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1)

Disease

Secondary outcome measures

Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 (Part 1 and Part 2)

Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 (Part 1 and Part 2)

Efficacy of ISB 1342 (disease control rate [DCR]) (Part 1 and Part 2)

+13 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ISB 1342Experimental Treatment1 Intervention

Part 1: Cohorts of multiple ISB 1342 dose levels; Part 2: One dose regimen until disease progression or other discontinuation criterion is met

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ichnos Sciences SALead Sponsor

6 Previous Clinical Trials

764 Total Patients Enrolled

2 Trials studying Multiple Myeloma

201 Patients Enrolled for Multiple Myeloma

Glenmark Pharmaceuticals S.A.Industry Sponsor

13 Previous Clinical Trials

2,158 Total Patients Enrolled

Media Library

ISB 1342 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03309111 — Phase 1

Multiple Myeloma Research Study Groups: ISB 1342

Multiple Myeloma Clinical Trial 2023: ISB 1342 Highlights & Side Effects. Trial Name: NCT03309111 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being recruited for this investigation at present?

"As the clinicaltrials.gov portal confirms, this trial is actively recruiting participants. It was first announced on October 25th 2017 and has been most recently updated on May 10th 2022."

Answered by AI

How extensively can patients access this clinical trial?

"Across the nation, 14 medical centres are actively enrolling participants; examples include Ichnos Investigational Site 8 in Nashville, Ichnos Investigational Site 5 in New york City, and Ichnos Investigational Site 6 in Rochester."

Answered by AI

What is the documented level of risk associated with ISB 1342 usage?

"This medication's safety is assessed as a 1 since this Phase I trial has little data to support its efficacy and associated hazards."

Answered by AI

How many participants have been enrolled in this trial to date?

"Affirmative. According to information listed on clinicaltrials.gov, this medical study is currently enrolling participants since its inception in October of 2017 and the most recent update made in May 2022. 245 volunteers are sought at 14 different trial sites across America."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma

2017. "Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03309111.