A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed/Refractory Multiple Myeloma ISB 2001

What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Additional Trial Information

Phase 1

Enrollment: 80 patients (estimated)

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Published Results

First Results of a Phase 1, First-in-Human, Dose Escalation Study of ISB 2001, a BCMAxCD38xCD3 Targeting Trispecific Antibody in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

December 09, 2024

Results: Based on data extracted on 29-Jul-2024, 14 pts were treated with ISB 2001 in dose escalation: target dose 5 μg/kg (n =1); 15 μg/kg (n =1); 50 μg/kg (n =1); 150 μg/kg (n =4); 300 μg/kg (n =3); 600 μg/kg (n =4)and received at least one cycle of ISB 2001. Median age was 66y; 57.1% male, 92.9% white. Pts had median of 4 prior regimens (range: 2 to 10). All 14 pts were triple-exposed, 9/14 penta-exposed (3/9 penta-refractory). Median follow-up was 2.2 months (range, 1.0 to 6.6). No DLT was observed. AEs of special interest were : injection site reaction Grade (Gr) 1 in 7 pts; lower and upper respiratory tract infection in the same patient (Gr2 and Gr1, respectively) and one Gr3 urinary tract infection; no ICANS were reported; CRS occurred in 71.4% (10 out of 14) of the pts. All were Gr1, except one Gr2. CRS was most common after the first priming dose (64.3% of pts), 14.3% post C1D4, 7.1% post C1D8. Median time to CRS was 2 days with a median duration of 1.5 days (range: 1 to 4). Tocilizumab was used in 3 patients. No patient discontinued the treatment due to a TEAE and no treatment-related death was reported.

During the dose escalation, Overall Response Rate (ORR) was 75% (9 of 12 efficacy-evaluable pts) across all doses, stringent CR (sCR), MRD negative was 8.3%, VGPR 16.7% and PR 50.0%. Objective response was observed with dose level as low as 50μg/kg and ORR in doses ≥50μg/kg was 90%. Median time to response was 36 days (range: 29 to 57) with responses deepening over time. 100% (9/9) of responses were still on treatment at data extract. ISB 2001 was slowly absorbed into the circulation after weekly dosing with Tmax generally occurring 7 days post dosing. PK data up to 150 µg/kg indicate general dose linear increase in serum exposures and available data imply a tentative half-life of 12 days . Transient increases in T-cell activation, proliferation and functional markers were observed following ISB 2001 administration, consistent with the T-cell dependent mechanism of action.

Conclusion: ISB 2001, a novel, FIH, BCMAxCD38xCD3 trispecific antibody is well tolerated with low grade CRS and manageable safety profile up to 600 μg/kg. Sustained objective responses were demonstrated from 50μg/kg (MRD neg, sCR) in pts with heavily pre-treated RRMM, with a high ORR of 75% across dose levels. Dose-escalation continues with no DLT observed thus far (NCT05862012).

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

Stanford University Cancer Institute (Palo Alto)

Stanford, CA

Open and Accepting

New York

Montefiore Medical Center (Moses Campus)

The Bronx, NY

Open and Accepting

North Carolina

UNC Lineberger Comprehensive Cancer Center University of North Carolina

Chapel Hill, NC

Open and Accepting
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