Assessing a new treatment for relapsed or refractory multiple myeloma

A Phase 1b, Open-Label Study of the Safety and Efficacy of Allogeneic Anti-CD38 A2 Dimeric Antigen Receptor (DAR)-T Cells in Patients With Relapsed or Refractory Multiple Myeloma

This study is testing a new treatment called STI-1492 to see if it can help people with relapsed or refractory multiple myeloma feel better after their previous treatments didn't work.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sorrento Therapeutics, Inc. (industry)
• Locations: 3 sites (Orange, California and 2 other locations)
• Trial ID: NCT05007418 on ClinicalTrials.gov

What this trial studies

This phase 1b, open-label, multicenter study evaluates the safety and preliminary efficacy of STI-1492, an allogeneic anti-CD38 A2 dimeric antigen receptor T cell therapy, administered via a single intravenous infusion to patients with relapsed or refractory multiple myeloma. The study employs a dose-escalation design to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Patients will be enrolled sequentially within cohorts, with staggered intervals of at least 28 days between subjects receiving treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals with relapsed or refractory multiple myeloma who have previously received anti-myeloma treatments and meet specific eligibility criteria.

Not a fit: Patients who have received systemic therapy for multiple myeloma within 14 days prior to the study or those with unresolved toxicity from previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat multiple myeloma.

How similar studies have performed: While this approach is novel, similar studies targeting CD38 in multiple myeloma have shown promising results.

Eligibility criteria

Inclusion Criteria:

* Must have relapsed or refractory multiple myeloma (RRMM) after having received prior lines of anti-myeloma treatments.
* Measurable disease as defined by one of the following: abnormal serum or M-protein levels; abnormal serum free light chain (FLC) assay; ≥ 30% clonal plasma cells in the bone marrow aspirate or biopsy sample
* Evidence of cell membrane CD38 expression as determined by immunohistochemistry (IHC) analysis ofbone marrow biopsy or extramedullary plasmacytoma
* Pulse oximetry ≥ 92% on room air
* Have a life expectancy ≥ 12 weeks
* Be willing and able to comply with the study schedule and all study requirements
* Willing to follow contraception guidelines

Exclusion Criteria:

* Previous treatment with any systemic therapy for multiple myeloma within 14 days prior to start of study dose
* Treatment with any cellular therapy within 8 weeks prior to start of study dose
* Have any unresolved toxicity ≥ Grade 2 from previous anticancer therapies
* A history of brain metastasis or spinal cord compression
* Has an ECOG performance status (PS) ≥ 3
* Has received allogeneic hematopoietic stem cell transplantation (HSCT) within 6 months, has active graft-versus-host disease (GvHD) following transplant, or is currently receiving immunosuppressive therapy following transplant
* Has any clinically significant low baseline lab results for hemoglobin, platelet counts, and neutrophil counts at screening unless resulting from underlying RRMM
* Has any clinically significant elevated baseline lab results for serum creatinine, AST or β2 microglobulin
* Abnormal INR or aPTT, unless on a stable dose of an anticoagulant
* Has known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C
* Is currently pregnant or breast feeding or planning on either during the study.
* Has an active bacterial, viral, or fungal infection
* Has active plasma cell leukemia
* Has extramedullary plasmacytoma(s)
* Has any significant medical condition, abnormality, or psychiatric illness that would prevent study participation
* Has left ventricular ejection fraction (LVEF) \< 40%
* Has second primary malignancies (SPMs) in addition to multiple myeloma if the SPM has required therapy within the last 3 years or is not in complete remission
* Has any additional clinical history of the CNS or cardiovascular disease that would place the patient at an unacceptable risk if the patient participates in the study

Where this trial is running

Orange, California and 2 other locations

• UC Irvine — Orange, California, United States (NOT_YET_RECRUITING)
• UC Davis — Sacramento, California, United States (NOT_YET_RECRUITING)
• University of Oklahoma — Oklahoma City, Oklahoma, United States (RECRUITING)

Study contacts

• Study coordinator: Mike Royal, MD

Conditions: Multiple Myeloma, multiple myeloma, Anti-CD38 A2 DAR-T Cells, Relapsed or Refractory Multiple Myeloma