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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05007418
Recruitment Status : Recruiting
First Posted : August 16, 2021
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: STI-1492 Phase 1

Detailed Description:

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

The study will determine the MTD and RP2D, assessing safety and preliminary efficacy using a conventional 3+3 study design with two design stages, an ascending dose stage followed by an expansion study.

Patients will be enrolled sequentially within each cohort and between cohorts during the dose escalation portion of the study with the staggered intervals of at least 28 days. Only one patient will be allowed to receive study treatment at any time through the end of the staggering period before the next subject may begin study treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 30, 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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.
Biological: STI-1492
Anti-CD38 A2 KOKI DAR T cells




Primary Outcome Measures :
  1. Safety of STI-1492 [ Time Frame: Baseline through study completion at up to approximately 54 months ]
    Safety as assessed by incidence of adverse events, SAEs, DLTs, neurotoxicity, cytokine release syndrome, host rejection, and laboratory abnormalities


Secondary Outcome Measures :
  1. Overall response and duration [ Time Frame: Baseline through study completion at up to approximately 54 months ]
    Response and duration according to the International Myeloma Working Group (IMWG) response criteria

  2. Assessment of improvements in hypercalcemia, renal function, anemia and lytic bone lesions (CRAB criteria) [ Time Frame: Baseline through study completion at up to approximately 54 months ]
    Assessment of improvement in CRAB criteria

  3. Assessment of serum immunoglobulin levels [ Time Frame: Baseline through study completion at up to approximately 54 months ]
    Assessment of serum immunoglobulin levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05007418


Contacts
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Contact: Mike Royal, MD (858)203-4100 ext 4146 mroyal@sorrentotherapeutics.com

Locations
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United States, California
UC Irvine Not yet recruiting
Orange, California, United States, 92868
Contact: Blake Johnson    714-456-3476    blakej@hs.uci.edu   
UC Davis Not yet recruiting
Sacramento, California, United States, 95817
Contact: Erika Crawford    916-501-9393    encrawford@ucdavis.edu   
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Silas Day    405-271-8001    silas-day@ouhsc.edu   
Principal Investigator: Adam Asch, MD         
Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD Sorrento Therapeutics, Inc.
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05007418    
Other Study ID Numbers: 38DART-RRMM-101
First Posted: August 16, 2021    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sorrento Therapeutics, Inc.:
multiple myeloma
Anti-CD38 A2 DAR-T Cells
Relapsed or Refractory Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases