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CAR T-cell Therapy

Engineered NK Cell Therapy for Multiple Myeloma

Phase 1 & 2

Recruiting

Led By Muzaffar Qazilbash, M D

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No active or uncontrolled infection at the start of lymphodepletion and/or cell infusion

Patients with relapsed or refractory MM (patients with solitary plasmacytoma are not eligible) who meet specific criteria including prior lines of therapy, measurable disease, refractory status, prior treatments, recovery from systemic toxicity, absence of active infection, and other specified conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a specific type of cell therapy for patients with multiple myeloma that has relapsed or not responded to other treatments.

Who is the study for?

This trial is for adults aged 18-80 with relapsed/refractory multiple myeloma, who haven't had recent vaccines or systemic steroids, and have no active infections. Participants must weigh at least 40 kg, not be on live vaccines or certain therapies targeting NY-ESO-1, and practice birth control. They should also have adequate organ function and a specific immune system marker (HLA-A*02:01).Check my eligibility

What is being tested?

The study tests genetically engineered NK cells with NY-ESO-1 TCR/IL-15 receptors alongside drugs Cyclophosphamide and Fludarabine phosphate to find the best dose for controlling multiple myeloma that has come back or resisted treatment.See study design

What are the potential side effects?

Potential side effects include reactions from the infusion of NK cells, effects on blood counts due to chemotherapy agents like Cyclophosphamide and Fludarabine phosphate, increased risk of infection, fatigue, nausea, liver toxicity, and possible autoimmune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any ongoing or untreated infections.

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I have multiple myeloma that has not responded to treatment or has come back.

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I weigh at least 40 kg.

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I am not currently on antibiotics for an infection.

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I am able to live at home and care for most of my personal needs.

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My multiple myeloma tests positive for NY-ESO-1.

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My HLA type is HLA-A*02:01.

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I am between 18 and 80 years old.

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I have plasma cell leukemia and have undergone at least two treatments.

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My bone marrow is working well without transfusions in the past week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part B: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENTExperimental Treatment3 Interventions

Group II: Part B2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENTExperimental Treatment3 Interventions

Group III: Part A: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENTExperimental Treatment3 Interventions

Group IV: Part A2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENTExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine phosphate

2007

Completed Phase 2

~360

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,430 Total Patients Enrolled

76 Trials studying Multiple Myeloma

5,773 Patients Enrolled for Multiple Myeloma

Muzaffar Qazilbash, M DPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

Is this endeavor currently recruiting participants?

"Per the information displayed on clinicaltrials.gov, this research is no longer recruiting participants. The study was initially posted on May 1st 2024 and most recently updated on September 27th 2023; however, there are 825 other trials open for enrollment in its place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I/II Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma

2023. "Phase I/II Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06066359.