KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Christian Hinrichs
Study ID
NCT05483491
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KK-LC-1 TCR-T cells — BIOLOGICAL
    Participants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine. KK-LC-1 TCR-T cells will be administered as a single intravenous infusion.
  • Aldesleukin — DRUG
    Aldesleukin 720,000 IU/kg IV every 8 hours will be preferentially administered as an inpatient within 24 hours after KK-LC-1 TCR-T cell infusion for up to 6 doses; however up to 24 hours may elapse between doses. Aldesleukin dosing will be stopped for aldesleukin-related grade 3 or greater toxicity other than flushing, fever, chills, or hemodynamic changes (tachycardia or hypotension) that respond to crystalloid infusion. Aldesleukin may also be stopped at any time at investigator discretion.

Study Details

This is a phase I clinical trial to determine the maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells for the treatment of metastatic cancers that express KK-LC-1. Participants will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. The safety profile and clinical response to treatment will be determined.

Key Dates

Start date
Sep 26, 2022
Status verified
Jun 2026
Primary completion
Sep 1, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: KK-LC-1 TCR-T cells
    Subjects will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin.

Primary Outcome Measure

Maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells [ Time Frame: 30 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Tobi Adewale
[email protected]
732-710-2406
RWJBarnabas Health - Robert Wood Johnson University HospitalNew BrunswickNew Jersey08901
Tobi Adewale
[email protected]
732-710-2406

Find similar trials in New Brunswick, NJ

By condition
Breast cancerCervical cancerGastric cancerLung cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncologyGI oncologyLung oncologyLung disease
By research site
Rutgers Cancer Institute· New Brunswick, NJRWJBarnabas Health - Robert Wood Johnson University Hospital· New Brunswick, NJ

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