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A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors

NCT06237881 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-02-18

No results posted yet for this study

Summary

To learn if KSQ-001EX is safe to give to participants with advanced forms of solid tumors.

Conditions

  • Advanced Solid Tumor
  • Melanoma
  • Lung Neoplasms
  • Head and Neck Neoplasms

Interventions

DRUG

KSQ-001EX

Given by IV

DRUG

Interleukin-2

Given by IV

DRUG

Cyclophosphamide

Given by IV

DRUG

Fludarabine

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
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2027-01-01
Completion
2029-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06237881 on ClinicalTrials.gov