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

NCT06066359 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2023-0171NCI-2023-08318
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Myeloma

Outcome Measures

Primary Outcomes (1)

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

  through study completion; an average of 1 year

Study Arms (4)

Part A: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT

EXPERIMENTAL

Drug: Fludarabine phosphate; Drug: Cyclophosphamide; Drug: NY-ESO-1 TCR/IL-15 NK

Part A2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT

EXPERIMENTAL

Drug: Fludarabine phosphate; Drug: Cyclophosphamide; Drug: NY-ESO-1 TCR/IL-15 NK

Part B: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT

EXPERIMENTAL

Drug: Fludarabine phosphate; Drug: Cyclophosphamide; Drug: NY-ESO-1 TCR/IL-15 NK

Part B2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT

EXPERIMENTAL

Drug: Fludarabine phosphate; Drug: Cyclophosphamide; Drug: NY-ESO-1 TCR/IL-15 NK

Interventions

Fludarabine phosphate DRUG

Given by (IV) vein

Also known as: Fludarabine, Fludara®

Part A2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT; Part A: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT; Part B2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT; Part B: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT

Cyclophosphamide DRUG

Given by (IV) vein

Also known as: Cytoxan®, Neosar®

Part A2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT; Part A: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT; Part B2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT; Part B: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT

NY-ESO-1 TCR/IL-15 NK DRUG

Given by (IV) vein

Part A2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT; Part A: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT; Part B2: Cell therapy with NY-ESO-1 TCR/IL-15 NK - OUTPATIENT; Part B: Cell therapy with NY-ESO-1 TCR/IL-15 NK - INPATIENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with multiple myeloma with an expression of NY-ESO-1 by immunohistochemistry in the pre-enrollment tumor sample
• Patients are HLA-A\*02:01positive on HLA typing
• Patients with relapsed or refractory MM (patients with solitary plasmacytoma are not eligible) who meet the following criteria:
• \> or = 4 prior lines of therapy (including exposure to at least one proteasome inhibitor, ImiD, and anti-cd38 antibody and bcma targeted agent
• have measurable disease (serum monoclonal (M) protein level ≥0.5 g/dL, and/or urine M protein level ≥200 mg/day, and/or involved serum FLC level ≥10 mg/dL provided the serum-free light-chain ratio is abnormal \*refractory is defined as a documented progressive disease during or within 60 days \[measured from the last dose of any drug within the regimen\] of completing treatment with the last anti-myeloma regimen before study entry.
• Patients with relapsed or refractory plasma cell leukemia who have received at least two previous regimens
• Patients at least 2 weeks from the last anti-myeloma therapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least three days prior to administration of lymphodepleting chemotherapy. Small molecule targeted therapies will not include targeted immune therapies, such as daratumumab, isatuximab or elotuzumab.
• Prior autologous/allogeneic transplants are allowed.
• Prior cell therapy is allowed against targets other than NY-ESO-1.
• Patients must have recovered from systemic toxicity of prior anti-myeloma therapy at the start of lymphodepletion.
• No active or uncontrolled infection at the start of lymphodepletion and/or cell infusion.
• No therapeutic systemic corticosteroids (\>/= 20 mg prednisone or equivalent) within 72 hours of lymphodepleting therapy.
• Patients with concurrent autoimmune diseases with neurologic involvement, such as multiple sclerosis will be excluded.
• Localized radiotherapy to one or more disease sites is allowed prior the infusion provided that there are additional disease sites that are not irradiated
• Karnofsky Performance Scale \> 50%.

You may not qualify if:

• \. None

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

fludarabine phosphate; fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Muzaffar Qazilbash, M D

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muzaffar Qazilbash, M D

CONTACT

(713) 745-3458; mqazilba@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)