Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
NCT06066359

Ph I/II Trial of Cord Blood-derived NK Cells With NY-ESO-1 TCR/IL-15 for R/R Myeloma

Led by M.D. Anderson Cancer Center · Updated on 2026-05-13

44

Participants Needed

1

Research Sites

248 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To find the recommended dose of NY-ESO-1 TCR/IL-15 NK cells that can be given to patients with relapsed or refractory MM. To learn if the dose of NY-ESO-1 TCR/IL-15 NK cells found in Part A can help to control the disease.

CONDITIONS

Official Title

Ph I/II Trial of Cord Blood-derived NK Cells With NY-ESO-1 TCR/IL-15 for R/R Myeloma

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with multiple myeloma expressing NY-ESO-1 confirmed by testing
  • Positive for HLA-A02:01, HLA-A2:05, or HLA-A*2:06 at any time
  • Relapsed or refractory multiple myeloma with at least 2 prior therapies including a proteasome inhibitor, ImiD, and anti-CD38 antibody
  • Measurable disease with specified protein levels
  • Refractory to last therapy with progression during or within 60 days of last treatment
  • No anti-myeloma therapy within 7 days before lymphodepleting therapy
  • Recovery from prior therapy toxicity before lymphodepletion
  • ECOG performance status 2 or less
  • Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73 m²
  • Liver enzymes (ALT/AST) less than or equal to 2.5 times upper limit of normal or up to 5 times if liver metastases
  • Total bilirubin less than or equal to 1.5 mg/dL (up to 3.0 mg/dL if Gilbert's syndrome)
  • No history of liver cirrhosis or ascites
  • Cardiac ejection fraction 50% or higher
  • No significant pericardial effusion or uncontrolled cardiac conditions
  • No significant pleural effusion
  • Oxygen saturation above 92% on room air
  • Able to provide informed consent
  • Age between 18 and 80 years
  • Weight at least 40 kg
  • Absolute neutrophil count at least 1000
  • Hemoglobin at least 8 g/dL
  • Platelet count at least 25,000/uL
  • Effective birth control use for participants able to have children
  • Signed consent for long-term follow-up
  • Patients with relapsed or refractory plasma cell leukemia with at least two previous regimens
Not Eligible

You will not qualify if you...

  • Active or uncontrolled infection at lymphodepletion start or cell infusion
  • Autoimmune diseases with neurological involvement (e.g., multiple sclerosis)
  • Receipt of live vaccines within 30 days before study entry
  • Active infection requiring systemic antibiotics
  • Another malignancy within the past 2 years not treated with curative intent, except certain low-risk cancers
  • Major surgery within 28 days or minor surgery within 14 days before lymphodepletion
  • Planned medical or surgical procedures that might jeopardize safety as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

M

Muzaffar Qazilbash, M D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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