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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

NCT06598371 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2026-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Select Advanced Solid Tumors

Interventions

DRUG

Cyclophosphamide

Given by IV

DRUG

Fludarabine

Given by IV

DRUG

KSQ-004EX

Given by IV

DRUG

Interleukin-2

Given by IV

Sponsors & Collaborators

  • KSQ Therapeutics, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Rodabe N Amaria, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2039-08-01
Completion
2041-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06598371 on ClinicalTrials.gov