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

NCT05007418 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 38DART-RRMM-101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety of STI-1492

  Safety as assessed by incidence of adverse events, SAEs, DLTs, neurotoxicity, cytokine release syndrome, host rejection, and laboratory abnormalities

  Baseline through study completion at up to approximately 54 months

Secondary Outcomes (3)

• Overall response and duration

  Baseline through study completion at up to approximately 54 months

• Assessment of improvements in hypercalcemia, renal function, anemia and lytic bone lesions (CRAB criteria)

  Baseline through study completion at up to approximately 54 months

• Assessment of serum immunoglobulin levels

  Baseline through study completion at up to approximately 54 months

Study Arms (1)

STI-1492

EXPERIMENTAL

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.

Biological: STI-1492

Interventions

STI-1492 BIOLOGICAL

Anti-CD38 A2 KOKI DAR T cells

STI-1492

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (3)

UC Irvine

Orange, California, 92868, United States

NOT YET RECRUITING

UC Davis

Sacramento, California, 95817, United States

NOT YET RECRUITING

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Mike Royal, MD

CONTACT

(858)203-4100; mroyal@sorrentotherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To determine DLT and MTD, the design uses a 3+3 rule-based design. Dose escalation is permitted between successive cohorts based upon a specified algorithm, using discrete dosage steps.

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start: October 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

US (3)