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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STI-1492
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, Anti-CD38 A2 DAR-T Cells, Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Irvine
  • UC Davis
  • University of OklahomaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STI-1492

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety of STI-1492
Safety as assessed by incidence of adverse events, SAEs, DLTs, neurotoxicity, cytokine release syndrome, host rejection, and laboratory abnormalities

Secondary Outcome Measures

Overall response and duration
Response and duration according to the International Myeloma Working Group (IMWG) response criteria
Assessment of improvements in hypercalcemia, renal function, anemia and lytic bone lesions (CRAB criteria)
Assessment of improvement in CRAB criteria
Assessment of serum immunoglobulin levels
Assessment of serum immunoglobulin levels

Full Information

First Posted
August 9, 2021
Last Updated
January 12, 2023
Sponsor
Sorrento Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05007418
Brief Title
Study to Assess Allogeneic Anti-CD38 A2 Dimeric Antigen Receptor T Cells in 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorrento Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, Anti-CD38 A2 DAR-T Cells, Relapsed or Refractory Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
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)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STI-1492
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
STI-1492
Intervention Description
Anti-CD38 A2 KOKI DAR T cells
Primary Outcome Measure Information:
Title
Safety of STI-1492
Description
Safety as assessed by incidence of adverse events, SAEs, DLTs, neurotoxicity, cytokine release syndrome, host rejection, and laboratory abnormalities
Time Frame
Baseline through study completion at up to approximately 54 months
Secondary Outcome Measure Information:
Title
Overall response and duration
Description
Response and duration according to the International Myeloma Working Group (IMWG) response criteria
Time Frame
Baseline through study completion at up to approximately 54 months
Title
Assessment of improvements in hypercalcemia, renal function, anemia and lytic bone lesions (CRAB criteria)
Description
Assessment of improvement in CRAB criteria
Time Frame
Baseline through study completion at up to approximately 54 months
Title
Assessment of serum immunoglobulin levels
Description
Assessment of serum immunoglobulin levels
Time Frame
Baseline through study completion at up to approximately 54 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Royal, MD
Phone
(858)203-4100
Ext
4146
Email
mroyal@sorrentotherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Royal, MD
Organizational Affiliation
Sorrento Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UC Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blake Johnson
Phone
714-456-3476
Email
blakej@hs.uci.edu
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Crawford
Phone
916-501-9393
Email
encrawford@ucdavis.edu
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silas Day
Phone
405-271-8001
Email
silas-day@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Adam Asch, MD

12. IPD Sharing Statement

Learn more about this trial

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

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