Actively Recruiting
A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma
Led by M.D. Anderson Cancer Center · Updated on 2026-05-04
40
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find a recommended dose of attIL2-T cell therapy that can be given to patients with soft tissue or bone sarcomas and to see if it can help to control the disease.
CONDITIONS
Official Title
A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older
- Histologically confirmed locally advanced or metastatic soft tissue or bone sarcoma
- For osteosarcoma cohort: unresectable recurrent or metastatic osteosarcoma confirmed by tissue
- Disease that can be evaluated
- Received at least one prior systemic therapy for sarcoma unless no standard therapy exists for the subtype
- At least 3 weeks since last chemotherapy or immunotherapy before leukapheresis
- At least 3 weeks since last chemotherapy or immunotherapy and 2 weeks since last radiation before starting cyclophosphamide
- ECOG performance status of 0 or 1
- Willingness to undergo tumor biopsy, unless medically contraindicated
- Adequate organ and marrow function including ANC above 1 K/uL, hemoglobin above 9 g/dL, platelets above 100 K/mm3
- Kidney function with serum creatinine below 2 mg/dL or creatinine clearance above 50 mL/min
- Liver function within 1.5 times the upper limit of normal for AST, ALT, and bilirubin
- Cardiac function with left ventricular ejection fraction above 50%
- Pulmonary function with oxygen saturation above 92% on room air and lung capacity tests above specified thresholds
- Women of childbearing potential must use effective contraception during and up to 3 months after therapy
- Men must use acceptable birth control during dosing and for 3 months after if partners are women of childbearing potential
- Signed informed consent and assent if applicable
You will not qualify if you...
- Known allergy to cyclophosphamide or study agents
- Active or recent autoimmune disease within past 2 years, except certain stable conditions
- Untreated or symptomatic central nervous system metastases or leptomeningeal disease
- Metastatic disease near critical structures posing high risk
- Concurrent cancer therapies at time of leukapheresis or T cell infusion, except allowed bridging therapies
- Unresolved toxicities from prior cancer therapy except specified exceptions
- History of primary immunodeficiency, organ transplant, or tuberculosis
- Receipt of live vaccines within 28 days before treatment
- Major surgery within 4 weeks before treatment or still recovering
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmia, active ulcers, or psychiatric/social issues affecting study compliance
- Active second cancer
- Pregnant or breastfeeding women
- Positive tests for hepatitis B, hepatitis C, or HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
John Livingston, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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