Trial Title:
Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma
NCT ID:
NCT05862012
Condition:
Relapsed/Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
ISB 2001
Relapsed/refractory multiple myeloma
Open-label
Dose escalation
Dose expansion
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ISB 2001
Description:
Participants will receive escalating doses of ISB 2001
Arm group label:
Part 1: Dose Escalation
Intervention type:
Drug
Intervention name:
ISB 2001
Description:
Participants will receive injection of ISB 2001 as determined in Part 1.
Arm group label:
Part 2: Dose Expansion
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).
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nishi Shah
Phone:
719-920-4826
Email:
nisshah@montefiore.org
Facility:
Name:
University of North Carolina
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eben Lichtman
Phone:
617-842-6051
Email:
eben_lichtman@med.unc.edu
Facility:
Name:
Pindara Private Hospital
Address:
City:
Benowa
Zip:
4217
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Hanlon Sia, MBBS(Adelaide), FRACP, FRCPA
Email:
drsia@fiho.com.au
Facility:
Name:
St. Vincent's Hospital Melbourne
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Hang Quach
Phone:
03 9231 2003
Email:
hang.quach@svha.org.au
Facility:
Name:
Peter MacCallum Cancer Center
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Amit Khot
Phone:
+6138559500
Email:
Amit.Khot@petermac.org
Facility:
Name:
Linear Clinical Research
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Bradley Augustston
Phone:
+61 (0) 8 6382 5100
Email:
bradley.augustson@health.wa.gov.au
Facility:
Name:
HCG Hospital
Address:
City:
Bangalore
Country:
India
Status:
Recruiting
Contact:
Last name:
Nataraj KS, MD
Phone:
9482141773
Email:
drnatarajks@gmail.com
Start date:
November 1, 2023
Completion date:
July 2027
Lead sponsor:
Agency:
Ichnos Sciences SA
Agency class:
Industry
Source:
Ichnos Sciences SA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05862012
