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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy (attIL12-TIL) for Advanced/Metastatic Soft Tissue and Bone Sarcoma Patients.

T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy (attIL12-TIL) for Advanced/Metastatic Soft Tissue and Bone Sarcoma Patients. (NCT06474676) is a Phase 1 interventional studying Metastatic Soft-tissue Sarcoma, sponsored by M.D. Anderson Cancer Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Metastatic Soft-tissue Sarcoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 12 years old 2. Histologically-confirmed locally advanced or metastatic soft tissue or bone sarcoma scheduled to undergo resection or biopsy as part of standard of care 3. Liposarcoma expansion cohort: diagnosed by tissue sample (biopsy-confirmed) unresectable recurrent/metastatic liposarcoma scheduled to undergo resection or biopsy as part of standard of care 4. Participants undergoing resection should have other measurable disease or be high risk for recurrence within 12 month per investigator assessment and has prior approval by PI. 5. Measurable disease according to RECIST 1.1 present prior to infusion of attIL12-TIL. If the only measurable disease is the same as the lesion biopsied for the study, it needs to be at least 2 cm in largest diameter. 6. Participants must have received at least 1 prior line of systemic therapy for the treatment of sarcoma, unless no standard therapy exists for a specific sarcoma subtype. 7. At least 3 weeks must have elapsed since the last cytotoxic chemotherapy or immunotherapy prior to tumor tissue collection. For targeted therapies, at least 4 half-lives or 3 weeks must have elapsed prior to tumor tissue collection (whichever is shorter). Standard of care anti- cancer therapy will be permitted following tumor tissue collection but prior to initiation of cyclophosphamide such that at least 3 weeks must have elapsed since last cytotoxic chemotherapy or immunotherapy prior to starting treatment with cyclophosphamide. For targeted therapies, at least 4 half-lives or 3 weeks must have elapsed prior to initiation of treatment with cyclophosphamide (whichever is shorter). Investigational anti-cancer therapy will not be permitted. 8. At least 2 weeks must have elapsed for palliative radiation to any tumor site other than the tumor site identified for tissue collection 9. Participants must have organ and marrow function as defined below ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age ≥ 12 years old 2. Histologically-confirmed locally advanced or metastatic soft tissue or bone sarcoma scheduled to undergo resection or biopsy as part of standard of care 3. Liposarcoma expansion cohort: histologically confirmed unresectable recurrent/metastatic liposarcoma scheduled to undergo resection or biopsy as part of standard of care 4. Participants undergoing resection should have other measurable disease or be high risk for recurrence within 12 month per investigator assessment and has prior approval by PI. 5. Measurable disease according to RECIST 1.1 present prior to infusion of attIL12-TIL. If the only measurable disease is the same as the lesion biopsied for the study, it needs to be at least 2 cm in largest diameter. 6. Participants must have received at least 1 prior line of systemic therapy for the treatment of sarcoma, unless no standard therapy exists for a specific sarcoma subtype. 7. At least 3 weeks must have elapsed since the last cytotoxic chemotherapy or immunotherapy prior to tumor tissue collection. For targeted therapies, at least 4 half-lives or 3 weeks must have elapsed prior to tumor tissue collection (whichever is shorter). Standard of care anti- cancer therapy will be permitted following tumor tissue collection but prior to initiation of cyclophosphamide such that at least 3 weeks must have elapsed since last cytotoxic chemotherapy or immunotherapy prior to starting treatment with cyclophosphamide. For targeted therapies, at least 4 half-lives or 3 weeks must have elapsed prior to initiation of treatment with cyclophosphamide (whichever is shorter). Investigational anti-cancer therapy will not be permitted. 8. At least 2 weeks must have elapsed for palliative radiation to any tumor site other than the tumor site identified for tissue collection 9. Participants must have organ and marrow function as defined below 10. Absolute neutrophil count (ANC) \> 1 K/uL, Hemoglobin \> 9 g/dL, Platelets \> 100 K/mm3 11. Serum creatinine \</= 2 mg/dL OR creatinine clearance \> 50 mL/min 12. Aspartic transaminase (AST) . 1.5 x upper limit of normal (ULN), Alanine transaminase (ALT) \</= 1.5 x ULN, Bilirubin ≤ 1.5 x ULN 13. Women of childbearing potential (WOCBP) must agree to use method(s) of contraception: at least one highly effective or two effective accepted methods of contraception to avoid conception throughout the study in such a manner that the risk of pregnancy is minimized. Suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal 14. Men must be willing and able to use an acceptable method of birth control such as latex condom during the dosing period and for at least 3 months after completion of the study agent administration (T cell infusion) if their sexual partners are WOCBP. 15. Signed Informed Consent and if applicable, pediatric assent Exclusion Criteria: 1. Known sensitivity to cyclophosphamide and/or study agents 2. Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Participants with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded 3. Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression. Participants previously treated central nervous system metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 14 days prior to first dose of attIL12-TIL cells are permitted to enroll. 4. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment at the time of tumor tissue collection or attIL12 TIL cell infusion. Any prior radiation to the tumor site that is being collected for attIL12 TIL production. Palliative radiation to any tumor site within the past 2 weeks. Standard of care anti-cancer therapy will be permitted following tumor tissue collection but prior to initiation of cyclophosphamide as bridging therapy (per section 5.5). Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable. 5. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5 Grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (eg, hearing loss) after consultation with the PI. 6. History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis. 7. Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products. 8. Major surgery (as defined by the investigator) within 4 weeks prior to first dose of treatment. Biopsy as per study protocol is allowed 9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unhealed wound, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from the study agents, or compromise the ability of the participant to give written informed consent. Participants with cognitive impairment, including adults with cognitive impairment such as trisomy 21 or similar conditions are not specifically excluded from participation, such that appropriate written informed consent is obtained from the parent or legal guardian and they are able to complete with the study protocol requirements and treatment. 10. Active concurrent second malignancy 11. Pregnant or lactating women 12. Any positive test result for hepatitis B or C virus indicating acute or chronic infection 13. Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome

Treatments Being Tested

DRUG

Cyclophosphamide

Given by IV

DRUG

T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy

Given by IV

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

MD Anderson Cancer Center
Houston, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06474676), the sponsor (M.D. Anderson Cancer Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06474676 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06474676?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06474676?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06474676. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06474676. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.