Multiple MyelomaPhase 1NCT05007418
Study to Assess Allogeneic Anti-CD38 A2 Dimeric Antigen Receptor T Cells in Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing STI-1492 in people with Multiple Myeloma, run by Sorrento Therapeutics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- STI-1492
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2022to Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Silas Day, 405-271-8001, silas-day@ouhsc.edu
Adam Asch, MD
- Not yet recruiting
UC Irvine
Orange, California, 92868
Blake Johnson, 714-456-3476, blakej@hs.uci.edu
- Not yet recruiting
UC Davis
Sacramento, California, 95817
Erika Crawford, 916-501-9393, encrawford@ucdavis.edu
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- STI-1492
- Keywords
- multiple myeloma, Anti-CD38 A2 DAR-T Cells, Relapsed or Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI-1492Biological
Anti-CD38 A2 KOKI DAR T cells
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: STI-1492 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of STI-1492
Safety as assessed by incidence of adverse events, SAEs, DLTs, neurotoxicity, cytokine release syndrome, host rejection, and laboratory abnormalities
Measured: Baseline through study completion at up to approximately 54 months
Secondary outcomes (3)
Overall response and duration
Response and duration according to the International Myeloma Working Group (IMWG) response criteria
Measured: Baseline through study completion at up to approximately 54 months
Assessment of improvements in hypercalcemia, renal function, anemia and lytic bone lesions (CRAB criteria)
Assessment of improvement in CRAB criteria
Measured: Baseline through study completion at up to approximately 54 months
Assessment of serum immunoglobulin levels
Assessment of serum immunoglobulin levels
Measured: Baseline through study completion at up to approximately 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Oct 2022
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Royal, MD, Study director, Sorrento Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007418
- Sponsor's protocol ID
- 38DART-RRMM-101
- Status last verified
- Jan 2023
- First submitted
- 9 Aug 2021
- Last updated
- 17 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05007418
- Acronym / sponsor ID
- 38DART-RRMM-101
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, Anti-CD38 A2 DAR-T Cells, Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| STI-1492 | Experimental | Biological: STI-1492Four 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STI-1492Anti-CD38 A2 KOKI DAR T cells | Biological | STI-1492 |
Primary outcome
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
3 secondary outcomes
Overall response and duration
Time frame: Baseline through study completion at up to approximately 54 months
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 serum immunoglobulin levels
Time frame: Baseline through study completion at up to approximately 54 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Royal, MD study director
Sorrento Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STI-1492 in people with Multiple Myeloma, run by Sorrento Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mike Royal, MD ((858)203-4100 ext. 4146, mroyal@sorrentotherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of STI-1492 (time frame: Baseline through study completion at up to approximately 54 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.