Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06083883
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Myxoid/Round Cell Liposarcoma
  • Synovial Sarcoma

Eligibility Criteria

Sex
ALL
Age
16 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine phosphate — DRUG
    Given by IV (vein)
  • NY-ESO-1 TCR/IL-15 NK — DRUG
    Given by IV (vein)
  • Cyclophosphamide — DRUG
    Given by IV (vein)

Study Details

The goal of this clinical research study is to find a recommended dose of donated NK cells that can be given along with chemotherapy to patients with advanced cancers. The safety and effects of this therapy will also be studied.

Key Dates

Start date
Mar 27, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation - Inpatient and Outpatient
    Participants will be assigned to receive a dose level of NK cells based on when the participants joins the study. Up to 6 participants will be enrolled at each dose level. If no intolerable side effects are seen after the first 3-6, the next group of participants will get at higher dose. Up to 4 dose levels of NK cells will be tested. If the first dosing group shows intolerable side effects, a lower dose will be tested.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
John Livingston, MD
[email protected]
713-792-3626
John Livingston, MD (SUB_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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