Actively Recruiting
A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted IL12 (attIL12)-T Cell Therapy Combined With Cyclophosphamide in Patients With Advanced or Metastatic Soft Tissue and Bone Sarcoma
Led by M.D. Anderson Cancer Center · Updated on 2026-05-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new T-cell membrane-anchored tumor targeted IL12 (attIL12)-T cell therapy combined with cyclophosphamide in patients with advanced or metastatic soft tissue or bone sarcomas. This phase 1 trial aims to find the best dose for treatment and to understand the safety, tolerability, and early signs of disease control, especially in patients with recurrent unresectable osteosarcoma. The study also explores immune responses and tumor cell changes related to the therapy. Participants will receive attIL12-T cell therapy combined with cyclophosphamide administered intravenously. The study includes two parts: Part A focuses on finding the safe and recommended dose, starting with the lowest dose, while Part B involves treating patients with osteosarcoma at the recommended dose found in Part A. Treatment schedules depend on the participant's group and study phase. During the trial, participants will undergo tumor biopsies when possible and provide blood samples to assess immune changes. Researchers will monitor adverse events to evaluate safety for about one year. The main measurement is the incidence of side effects, and disease control will also be assessed over four months. Participants must meet specific health and organ function criteria and will be closely followed up throughout the study period.
CONDITIONS
Brief 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, histologically confirmed unresectable recurrent or metastatic osteosarcoma
- Disease that can be evaluated
- Received at least one prior systemic therapy for sarcoma unless no standard therapy exists
- At least 3 weeks since last cytotoxic chemotherapy or immunotherapy before leukapheresis
- At least 4 half-lives or 3 weeks since targeted therapies before leukapheresis
- At least 3 weeks since last cytotoxic chemotherapy or immunotherapy before starting cyclophosphamide
- At least 2 weeks since last radiation therapy before cyclophosphamide
- No investigational anti-cancer therapy allowed during treatment
- ECOG performance status 0 or 1 (or Karnofsky/Lansky equivalents)
- Willingness to undergo tumor biopsy (unless medically contraindicated)
- Adequate organ and marrow function (specific lab value requirements)
- Women of childbearing potential must use effective contraception during and up to 3 months after treatment
- Men must use birth control during dosing and for 3 months after treatment
- Signed informed consent and pediatric assent if applicable
You will not qualify if you...
- Known allergy or sensitivity to cyclophosphamide or study drugs
- Active or recent autoimmune disease within past 2 years (some exceptions)
- Untreated central nervous system metastases or leptomeningeal disease
- Metastatic disease near critical structures posing immediate risk
- Concurrent chemotherapy, immunotherapy, or biologic/hormonal cancer treatment at leukapheresis or T cell infusion
- Unresolved toxicities from prior therapy except alopecia and specified labs
- History of primary immunodeficiency, organ transplant, or tuberculosis
- Live vaccine within 28 days before first dose
- Major surgery within 4 weeks before treatment
- Uncontrolled infections or illnesses limiting study compliance
- Active second cancer
- Pregnant or breastfeeding women
- Positive hepatitis B, C, or HIV infection tests
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration depends on dosing schedule and participant response
Participants receive adoptive transfer of T cell membrane-anchored tumor targeted IL12 (attIL12)-T cells combined with cyclophosphamide to treat advanced or metastatic soft tissue or bone sarcomas.
1 baseline visit and multiple treatment visits as per dosing schedule
Duration - Up to 1 year following treatment
Participants are monitored for safety, tolerability, and preliminary efficacy after treatment completion.
Regular follow-up visits over 1 year
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
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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