Recruiting

Phase 1

Anti-CD38 A2 DimericStudy to Assess Allogeneic Anti-CD38 A2 Dimeric Antigen Receptor T Cells in Relapsed or Refractory Multiple Myeloma

Sponsor:

Sorrento Therapeutics, Inc.

Code:

NCT05007418

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STI-1492

Study Details

Brief summary:

This is a phase 1b, open-label, dose-escalation study of STI-1492 administered by a single intravenous infusion in subjects with relapsed or refractory multiple myeloma.

Conditions

Multiple Myeloma

Study ID

NCT05007418

Start date

Oct 1, 2022

Status verified date

Jan, 2023

Completion date

Feb, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: STI-1492

Four dosing cohorts will be evaluated: Cohort 1 (1 × 10\^5 donor DAR-T cells/kg); Cohort 2 (5 × 10\^5 donor DAR-T cells/kg); Cohort 3 (1 × 10\^6 donor DAR-T cells/kg); Cohort 4 (3 × 10\^6 donor DAR-T cells/kg) where STI-1492 will be administered intravenously once.

Interventions

STI-1492

Anti-CD38 A2 KOKI DAR T cells

Primary outcome measure

Safety of STI-1492 [ Time Frame: Baseline through study completion at up to approximately 54 months ]

Central Contacts and Locations

Central contacts

Mike Royal, MD

(858)203-4100 mroyal@sorrentotherapeutics.com

Locations

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Silas Day

405-271-8001 silas-day@ouhsc.edu

Principal Investigator:

Adam Asch, MD

More Information

Sponsor

Sorrento Therapeutics, Inc.

Last update posted

Jan 17, 2023

Last verified

Jan, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sorrento Therapeutics, Inc. on 2023-01-17.