Actively Recruiting
T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy (attIL12-TIL) for Advanced/Metastatic Soft Tissue and Bone Sarcoma Patients.
Led by M.D. Anderson Cancer Center · Updated on 2026-02-27
40
Participants Needed
1
Research Sites
378 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find a recommended dose of attIL2-TIL cell therapy that can be given to participant with either relapsed or metastatic sarcomas (has come back or spread to other parts of the body, respectively). To further test the dose found in Part A to see if it can help to control liposarcoma growth.
CONDITIONS
Official Title
T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy (attIL12-TIL) for Advanced/Metastatic Soft Tissue and Bone Sarcoma Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older
- Histologically confirmed advanced or metastatic soft tissue or bone sarcoma scheduled for surgery or biopsy
- For liposarcoma group: unresectable recurrent or metastatic liposarcoma scheduled for surgery or biopsy
- Participants having surgery should have other measurable disease or be high risk for recurrence within 12 months
- Measurable disease present before attIL12-TIL infusion, with lesions at least 2 cm if only measurable lesion was biopsied
- 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 tumor tissue collection
- At least 3 weeks since last chemotherapy or immunotherapy before starting cyclophosphamide
- At least 2 weeks since palliative radiation to tumor sites other than tissue collection site
- Adequate organ and marrow function as defined by blood counts and lab tests
- Women of childbearing potential must use effective contraception during and up to 3 months after treatment
- Men must use birth control during treatment and for 3 months after if partners are women of childbearing potential
- Signed informed consent and pediatric assent if applicable
You will not qualify if you...
- Known allergy or sensitivity to cyclophosphamide or study agents
- Active or recent autoimmune disease within 2 years, except certain mild conditions not requiring treatment
- Untreated or unstable brain metastases or leptomeningeal disease
- Receiving other cancer treatments at tumor tissue collection or attIL12-TIL infusion
- Prior radiation to the tumor site used for TIL production; recent palliative radiation within 2 weeks
- Unresolved side effects from prior cancer treatments above mild levels
- History of primary immunodeficiency, organ transplant, or tuberculosis
- Live vaccine within 28 days before first study treatment
- Major surgery within 4 weeks before treatment start (biopsy per protocol allowed)
- Uncontrolled illnesses such as infection, heart failure, high blood pressure, ulcers, or psychiatric conditions limiting study compliance
- Active second cancer
- Pregnant or breastfeeding women
- Positive test for hepatitis B or C indicating active infection
- Known HIV or AIDS diagnosis
AI-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
N
Neeta Somaiah, MBBS
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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