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NCT06203912 · ClinicalTrials.gov registry record · Phase 1
Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma
A Phase 1 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma, sponsored by Elvira Umyarova.
- Active
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT06203912: Active Phase 1 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma, sponsored by Elvira Umyarova.
NCT06203912 is a Phase 1 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma that is active but no longer recruiting, run by Elvira Umyarova. The registered enrollment target is 3 participants, below the 48-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06203912, a Phase 1 study of Refractory Multiple Myeloma and Recurrent Multiple Myeloma, is active but no longer recruiting, sponsored by Elvira Umyarova.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the side effects and best dose of TGFbi natural killer (NK) cells (TiNK) when given together with isatuximab for the treatment of patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to treatment (refractory). NK cells are a type of white blood cell that are known to spontaneously attack cancer cells. TiNK are NK cells made in a laboratory to have a higher response to tumor cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as isatuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Patients also receive standard treatment (cyclophosphamide and dexamethasone) on this trial. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving TiNK and isatuximab with standard treatment may be a safe and effective treatment for relapsed or refractory multiple myeloma.
Primary Outcome
Will use the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 for AE collection. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of severe (grade 3+) adverse events or toxicities will be described. We will also assess tolerability of the regimen through assessing the number of patients who required dose modifications and/or dose
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- DRUG Dexamethasone
- PROCEDURE Bone Marrow Aspiration and Biopsy
- PROCEDURE Echocardiography
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2024-03-05 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 1 |
What the registry record for NCT06203912 still lists
NCT06203912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 48-participant average among 67 other Refractory Multiple Myeloma trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Refractory Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT06203912 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06203912 about?
NCT06203912 is a clinical study titled "Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma". This phase I trial tests the side effects and best dose of TGFbi natural killer (NK) cells (TiNK) when given together with isatuximab for the treatment of patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to treatment (refractory). N...
What is the current status of trial NCT06203912?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2024-03-05. Estimated completion is 2026-08-31.
What conditions does trial NCT06203912 study?
This clinical trial studies the following conditions: Refractory Multiple Myeloma, Recurrent Multiple Myeloma.
What interventions are being tested in trial NCT06203912?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Dexamethasone (DRUG), Bone Marrow Aspiration and Biopsy (PROCEDURE), Echocardiography (PROCEDURE).
Who is sponsoring clinical trial NCT06203912?
This trial is sponsored by Elvira Umyarova, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06203912 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Multiple Myeloma
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Where NCT06203912's enrollment target sits among peer trials
3 68th of 67 the lowest of 67 other Refractory Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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