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CAR T-cell Therapy

Anti-CD38 A2 DAR T Cells for Multiple Myeloma

Phase 1
Recruiting
Research Sponsored by Sorrento Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have relapsed or refractory multiple myeloma (RRMM) after having received prior lines of anti-myeloma treatments
Evidence of cell membrane CD38 expression as determined by immunohistochemistry (IHC) analysis of bone marrow biopsy or extramedullary plasmacytoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion at up to approximately 54 months
Awards & highlights

Study Summary

This trial is testing a new drug for subjects with multiple myeloma who have relapsed or who are refractory to current treatments.

Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma who've had previous treatments, can follow the study plan and contraception rules, have CD38 expression in their cancer cells, a life expectancy of at least 12 weeks, measurable disease levels, and good oxygen levels without assistance.Check my eligibility
What is being tested?
The trial tests STI-1492, an experimental therapy involving anti-CD38 T cells. It's given once through the vein to see how safe it is and what dose works best for people whose multiple myeloma has come back or didn't respond to treatment.See study design
What are the potential side effects?
Potential side effects are not specified but may include typical reactions related to immune cell infusions such as fever, fatigue, allergic reactions. Since this is an early-phase trial assessing safety and dosage, close monitoring will occur for any unexpected adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My multiple myeloma has returned or didn't respond after treatment.
Select...
My cancer shows CD38 on the cell surface.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion at up to approximately 54 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion at up to approximately 54 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of STI-1492
Secondary outcome measures
Assessment of improvements in hypercalcemia, renal function, anemia and lytic bone lesions (CRAB criteria)
Assessment of serum immunoglobulin levels
Overall response and duration

Trial Design

1Treatment groups
Experimental Treatment
Group I: STI-1492Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Sorrento Therapeutics, Inc.Lead Sponsor
47 Previous Clinical Trials
1,970 Total Patients Enrolled
2 Trials studying Multiple Myeloma
82 Patients Enrolled for Multiple Myeloma
Mike Royal, MDStudy DirectorSorrento Therapeutics, Inc.
27 Previous Clinical Trials
1,501 Total Patients Enrolled
1 Trials studying Multiple Myeloma
72 Patients Enrolled for Multiple Myeloma

Media Library

STI-1492 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05007418 — Phase 1
Multiple Myeloma Research Study Groups: STI-1492
Multiple Myeloma Clinical Trial 2023: STI-1492 Highlights & Side Effects. Trial Name: NCT05007418 — Phase 1
STI-1492 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05007418 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for prospective participants in this research endeavor?

"According to clinicaltrials.gov, this study is still searching for recruits; it was first made public on December 30th 2022 before being altered on November 14th of the same year."

Answered by AI

Could you elaborate on the safety profile of STI-1492?

"Due to the experimental nature of this Phase 1 trial, limited evidence exists to support both efficacy and safety. Thus it received a relatively low score of 1."

Answered by AI

How many persons are participating in this clinical trial?

"Affirmative. According to records on clinicaltrials.gov, this experiment is presently searching for individuals interested in participating. The trial was first unveiled on December 30th 2022 and has since been updated as of November 14th 2022. 54 participants need to be enlisted from 3 disparate sites."

Answered by AI
~28 spots leftby Dec 2025