Phase 1 Study Of LNK001 In Advanced Or Metastatic Clear Cell Renal Cell Carcinoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07564232
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given by IV
  • Fludarabine — DRUG
    Given by IV
  • LNK001 — DRUG
    Given by infusion

Study Details

There are 2 parts to this clinical research study: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The goal of Part 1 is to find the recommended dose of LNK001 in patients with advanced or metastatic ccRCC. The goal of Part 2 is to learn if the recommended dose of LNK001 found in Part 1 can help to control the disease.

Key Dates

Start date
Oct 1, 2026
Status verified
Apr 2026
Primary completion
Jun 6, 2031
Completion
Jun 6, 2033

Study Design

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

Arms

  • Experimental: Part 1/2: ESC/EXP treatment with CAR-T LNK001

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD AndersonHoustonTexas77030
Samer A Srour, MBBCH
713-794-4354
Samer A Srour, MBBCH (PRINCIPAL_INVESTIGATOR)

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