ISB 1342 for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Ichnos Sciences SA

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

I have active plasma cell leukemia.

I have not taken daratumumab or isatuximab in the last 2 months.

I do not have serious heart or lung conditions.

My cancer has spread to my brain or spinal cord.

I have a history of HIV infection.

I am not taking any medications that are not allowed in the study.

I have an active infection.

Participant Groups

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.

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