A Phase 1/2 Study of KSQ-004EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1, in Patients With Select Advanced Solid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06598371
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Select Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • Cyclophosphamide — DRUG
    Given by IV
  • Fludarabine — DRUG
    Given by IV
  • KSQ-004EX — DRUG
    Given by IV
  • Interleukin-2 — DRUG
    Given by IV

Study Details

Phase 1 is to find the recommended dose of KSQ-004EX to give to participants with advanced solid tumors. Phase 2 is to learn if KSQ-004EX at the recommended dose found in Phase1 can help to control advanced solid tumors. The safety and effects of KSQ-004EX will also be studied in both phases.

Key Dates

Start date
Nov 21, 2024
Status verified
May 2026
Primary completion
Aug 1, 2039
Completion
Aug 1, 2041

Study Design

Enrollment
141 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Backfill IL-2: Treatment with Lymphodepletion and KSQ-004EX + IL-2
    Participants will receive KSQ-004EX and pre-medicated with cyclophosphamide and fludarabine to prevent the lymphodepletion of the chemotherapy.
  • Experimental: Phase 1 mLDC: Treatment with Modified Lymphodepletion and KSQ-004EX
    Participants will receive KSQ-004EX and pre-medicated with cyclophosphamide and fludarabine to prevent the lymphodepletion of the chemotherapy.
  • Experimental: Phase 1/Phase 2: Treatment with Lymphodepletion and KSQ-004EX
    Participants will receive KSQ-004EX and pre-medicated with cyclophosphamide and fludarabine to prevent the lymphodepletion of the chemotherapy.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Rodabe N Amaria, MD
[email protected]
713-792-2921
Rodabe N Amaria, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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