Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
141
Participants Needed
1
Research Sites
871 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
K
KSQ Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with unresectable, incurable, or metastatic melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic ductal adenocarcinoma, or cervical carcinoma that has progressed after specified prior therapies
- Have a resectable tumor lesion of at least 1.5 cm2 or sufficient core needle biopsies for KSQ-004EX manufacturing
- Have at least one measurable tumor lesion per RECIST v1.1 after tumor resection
- Age 18 years or older
- Life expectancy of at least 12 weeks
- Recovered to Grade 1 or baseline toxicity from prior therapy (except hair loss, neuropathy, or certain endocrinopathies)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow, kidney, and liver function as defined by specified laboratory criteria
- Completed required washout periods from prior anticancer therapies and surgeries
- Female participants of childbearing potential must have negative pregnancy test and agree to effective contraception; male participants must agree to use effective contraception during and for 3 months after treatment
- Ability and willingness to sign informed consent
You will not qualify if you...
- Prior organ transplant or prior cell therapy with lymphodepleting chemotherapy
- Allergy to KSQ-004EX components or related drugs
- Active or prior autoimmune or inflammatory disorders except certain controlled conditions
- Allergy to certain antibiotics
- Active uncontrolled infection needing IV antibiotics
- Uveal or ocular melanoma
- Large cell neuroendocrine NSCLC
- Symptomatic or untreated brain metastases
- Presence of ascites
- Pregnant or nursing women
- HIV, active hepatitis B or C infection unless controlled
- Primary immunodeficiency or acute liver disease
- Prior solid organ or hematopoietic transplant
- Use of systemic steroids above 10 mg prednisone equivalent within 14 days before enrollment
- Recent live or unattenuated vaccine within 28 days before treatment
- Recent serious cardiovascular events within 3 months
- Significant heart failure, arrhythmia, or low ejection fraction
- QTc interval prolongation
- Inability to walk 80% predicted distance or develop low oxygen during 6-minute walk test
- Evidence of ischemia on cardiac stress test if receiving IL-2
- Significant carotid artery stenosis in certain patients
- Obstructive or restrictive lung disease or suspected pneumonitis
- Participation in another investigational study within 28 days
- Active additional malignancy needing treatment
- Psychiatric or social issues limiting study compliance
- Other severe medical conditions increasing risk or interfering with study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Rodabe N Amaria, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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