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New treatment option for Metastatic Soft-tissue Sarcoma
Official title T Cell Membrane-Anchored Tumor-Targeted IL12 -Modified TIL Cell Therapy (attIL12-TIL) for Advanced/Metastatic Soft Tissue and Bone Sarcoma Patients.
ClinicalTrials.gov ID: NCT06474676
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic soft-tissue sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Age ≥ 12 years old
- Histologically-confirmed locally advanced or metastatic soft tissue or bone sarcoma scheduled to undergo resection or biopsy as part of standard of...
- Liposarcoma expansion cohort: histologically confirmed unresectable recurrent/metastatic liposarcoma scheduled to undergo resection or biopsy as part...
- Participants undergoing resection should have other measurable disease or be high risk for recurrence within 12 month per investigator assessment and...
- 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...
You likely can't join if
- Known sensitivity to cyclophosphamide and/or study agents
- Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years...
- Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression. Participants previously treated central nervous...
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment at the time of tumor tissue collection or attIL12...
- 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...
- History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
See the full eligibility criteria
- Age ≥ 12 years old
- Histologically-confirmed locally advanced or metastatic soft tissue or bone sarcoma scheduled to undergo resection or biopsy as part of standard of care
- Liposarcoma expansion cohort: histologically confirmed unresectable recurrent/metastatic liposarcoma scheduled to undergo resection or biopsy as part of standard of care
- 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.
- 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.
- 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.
- 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...
- At least 2 weeks must have elapsed for palliative radiation to any tumor site other than the tumor site identified for tissue collection
- Participants must have organ and marrow function as defined below
- Absolute neutrophil count (ANC) \> 1 K/uL, Hemoglobin \> 9 g/dL, Platelets \> 100 K/mm3
- Serum creatinine \ 50 mL/min
- Aspartic transaminase (AST) . 1.5 x upper limit of normal (ULN), Alanine transaminase (ALT) \</= 1.5 x ULN, Bilirubin ≤ 1.5 x ULN
- 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...
- 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...
- Signed Informed Consent and if applicable, pediatric assent
- Known sensitivity to cyclophosphamide and/or study agents
- 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...
- 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...
- 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...
- 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. people with...
- History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
- Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products.
- Major surgery (as defined by the investigator) within 4 weeks prior to first dose of treatment. Biopsy as per study protocol is allowed
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unhealed wound, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac...
- Active concurrent second malignancy
- Pregnant or lactating women
- Any positive test result for hepatitis B or C virus indicating acute or chronic infection
- Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.