RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-01

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05007418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Mike Royal, MD

CONTACT

(858)203-4100

mroyal@sorrentotherapeutics.com

Principal Investigator

Mike Royal, MD

STUDY_DIRECTOR

Sorrento Therapeutics, Inc.

Study Locations (Sites)

UC Irvine

Orange, California, 92868

United States

UC Davis

Sacramento, California, 95817

United States

University of Oklahoma

Oklahoma City, Oklahoma, 73104

United States

Collaborators and Investigators

Sponsor: Sorrento Therapeutics, Inc.

Mike Royal, MD, STUDY_DIRECTOR, Sorrento Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01

Study Completion Date2026-02

Study Record Updates

Study Start Date2022-10-01

Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Multiple Myeloma