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

Conditions

• Relapsed/Refractory Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Fludarabine phosphate — DRUG
  Given by (IV) vein
• Cyclophosphamide — DRUG
  Given by (IV) vein
• Allogeneic Anti-NY-ESO-1-TCR-IL-15-transduced Cord Blood-derived Natural Killer Cells — DRUG
  Given by (IV) vein

Study Details

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.

Key Dates

Start date

Nov 30, 2023

Status verified

May 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2028

Study Design

Enrollment

44 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (lymphodepletion, NY-ESO-1 TCR/IL-15 NK cells)
  Patients receive fludarabine IV over 1 hour and cyclophosphamide IV over 3 hours on days -5, -4, and -3, followed by NY-ESO-1 TCR/IL-15 NK cells IV over 1-40 minutes on day 0. Patients who fail to achieve CR after receiving NY-ESO-1 TCR/IL-15 NK cells may receive up to 3 additional doses of NY-ESO-1 TCR/IL-15 NK cells and preceding lymphodepleting chemotherapy at 12 to 16 week intervals from day +0 of the previous cycle until the patient achieves CR or has completed a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo chest x-ray and ECHO or MUGA at screening, and undergo collection of blood samples, PET/CT scans and bone marrow aspiration/biopsy throughout the trial.

Primary Outcome Measure

Incidence of dose-limiting toxicities (Part A) [ Time Frame: Within 28 days of the natural killer (NK) cell infusion ]

Central Contacts

• Muzaffar Qazilbash, M D
  (713) 745-3458
  [email protected]

Locations (1)

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