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Monoclonal Antibodies
ISB 1342 for Multiple Myeloma
Phase 1
Waitlist Available
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
Must not have
Active plasma cell leukemia
Exposure to daratumumab or isatuximab within 2 months prior to the start of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
My multiple myeloma has returned or didn't respond to treatments including PIs, IMiDs, and anti-CD38.
Select...
My heart pumps well and I don't have fluid around my heart or lungs.
Select...
I am mostly self-sufficient but may not be able to do heavy physical work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have active plasma cell leukemia.
Select...
I have not taken daratumumab or isatuximab in the last 2 months.
Select...
I do not have serious heart or lung conditions.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I have a history of HIV infection.
Select...
I am not taking any medications that are not allowed in the study.
Select...
I have an active infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ISB 1342
2017
Completed Phase 1
~90
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active hepatitis B.I have active plasma cell leukemia.I have not taken daratumumab or isatuximab in the last 2 months.My heart pumps well and I don't have fluid around my heart or lungs.My multiple myeloma has returned or didn't respond to treatments including PIs, IMiDs, and anti-CD38.I do not have serious heart or lung conditions.You do not have hepatitis C, or if you do, further tests show that the virus is not active in your body.Your oxygen level is at least 92% when breathing regular air.My blood, kidney, and liver functions are all within normal ranges.My cancer has spread to my brain or spinal cord.I am mostly self-sufficient but may not be able to do heavy physical work.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.
Research Study Groups:
This trial has the following groups:- Group 1: ISB 1342
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.