A Phase 1 interventional study of Biospecimen Collection and Bone Marrow Aspiration and Biopsy in Recurrent Multiple Myeloma and Refractory Multiple Myeloma, sponsored by Elvira Umyarova. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Elvira Umyarova · Phase 1, Interventional, and Treatment
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 OBJECTIVE:
I. To evaluate the safety and tolerability of transforming growth factor beta imprinted natural killer cells (TiNK) and isatuximab in patients with multiple myeloma (MM) relapsed or refractory (R/R) to BCMA-targeting therapy.
SECONDARY OBJECTIVES:
I. To evaluate the objective response rate (ORR) by International Myeloma Working Group (IMWG) criteria of TiNK and isatuximab in patients with MM R/R to BCMA-targeting therapy.
II. To determine the time to response (TTR), time to next therapy (TTNT), the duration of response (DOR), progression free survival (PFS), and overall survival (OS) at 1 year.
III. To determine correlatives of outcomes. IV. To assess quality of life (QOL) with therapy.
OUTLINE: This is a dose-escalation study of TiNK followed by a dose-expansion study.
Patients receive cyclophosphamide intravenously (IV) on day 1, dexamethasone orally (PO) on days 1-4, TiNK IV on day 8, and isatuximab IV on days 8 and 15 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and biopsy during screening and on study, as well as optionally during follow up. Patients undergo echocardiography (ECHO) during screening and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days, 60 days. Patients who discontinue study treatment for reasons other than progressive disease follow up every 12 weeks for up to 2 years.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 3 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →This is the only study on the registry with Elvira Umyarova as lead sponsor.
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Patients 18 years of age or older with evidence of relapsed or refractory disease as defined by IMWG criteria and measurable disease as defined by any of the following:
Patients must have had at least 3 prior lines of therapy including lenalidomide, proteasome inhibitor (PI), anti-CD38 or anti-SLAMF7 directed antibody, and BCMA-targeting therapy.
Refractory (progressed on or within 60 days of treatment) to their last treatment
Platelets ≥ 70,000/µL
Fertility requirements:
Exclusion Criteria:
Patients with Waldenstrom macroglobulinemia, primary AL amyloidosis, primary plasma cell leukemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
Unacceptable respiratory risk factors defined by any one of the following criteria:
Unacceptable cardiac risk factors defined by any of the following criteria:
Patients with known positivity for human immunodeficiency virus (HIV) or active hepatitis B/C
Patients receive cyclophosphamide IV on day 1, dexamethasone PO on days 1-4, TiNK IV on day 8, and isatuximab IV on days 8 and 15 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and biopsy during screening and on study, as well as optionally during follow up. Patients undergo ECHO during screening and blood sample collection throughout the study.
Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration and Biopsy · Drug: Cyclophosphamide · Drug: Dexamethasone · Procedure: Echocardiography · Biological: Isatuximab · Other: Questionnaire Administration · Biological: Universal Donor Expanded TGF-beta-imprinted NK Cells
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo bone marrow aspiration and biopsy
Given IV
Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B-518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719, WR-138719
Given PO
Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex
Undergo echocardiography
Also known as: EC
Given IV
Also known as: Hu 38SB19, Isatuximab-irfc, SAR 650984, SAR-650984, SAR650984, Sarclisa
Ancillary study
Given IV
Also known as: Allogeneic TGFBi Expanded NK Cells, UD TGF-betai NK Cells, Universal Donor TGF-beta Imprinted Expanded NK Cells
Incidence and severity of adverse events (AE)
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 delays. In addition, we will capture the proportion of patients who go off treatment due to adverse reactions.
Time frame: Up to 60 days after completion of study treatment
Overall response rate (ORR)
Will be defined as the total number of subjects whose best response is partial response (PR) or better divided by the number of patients. Will be reported overall with 95% binomial exact confidence intervals. Comparison of ORR among patient subgroups will be conducted using Fisher exact test.
Time frame: Up to 2 years after completion of study treatment
Time to response
Cumulative incidence rates will be calculated and compared using Gray's test accounting for competing risks.
Time frame: From start of treatment until measurement criteria are first met for PR, very good partial response (VGPR), or complete response (CR), assessed up to 2 years after completion of study treatment
Time to next therapy
Cumulative incidence rates will be calculated and compared using Gray's test accounting for competing risks.
Time frame: From start of treatment until initiation of the next line of therapy, assessed up to 2 years after completion of study treatment
Duration of response
Will be computed for subjects whose best response is either PR, VGPR, or CR. Will be analyzed using the Kaplan-Meier method.
Time frame: From the time measurement criteria are first met for PR or better (whichever status is recorded first) until the first date of progressive disease or death, assessed up to 2 years after completion of study
Progression free survival
Will be analyzed using the Kaplan-Meier method.
Time frame: From start of treatment until disease progression or death, at 1 year
Overall survival
Will be analyzed using the Kaplan-Meier method.
Time frame: From start of treatment to the date of his or her death, at 1 year
Change in quality of life (QOL) using PROMIS G10
Using the Patient-Reported Outcomes Measurement Information System Global 10 Quality of Life Survey (PROMIS G10 QOL) A repeated measures linear mixed model will be fit to all QOL scores. The response options are presented as 5-point (and single 11-point for pain rating scales). The results of the questions are used to calculate two summary scores.
Time frame: Baseline up to 60 days after completion of study treatment
Change in quality of life (QOL) using EORTC QLQ-MY20
Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma20 (EORTC QLQ - MY20). A repeated measures linear mixed model will be fit to all QOL scores. This incorporates four multi-item scales to assess disease symptoms, side effects of treatment, future perspective and body image. All of the scales and single-item measures range in score from 0 to 100. A high score for the symptom scales represents a high level of symptomatology or problems, whereas a high score for the functional scale represents a high level of functioning.
Time frame: Baseline up to 60 days after completion of study treatment
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