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New treatment option for Myxoid Liposarcoma
Official title N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy
ClinicalTrials.gov ID: NCT07261657
What this study is testing
What is Nogapendekin Alfa Inbakicept?
Nogapendekin Alfa Inbakicept is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myxoid liposarcoma.
Also referred to as ALT 803, ALT-803.
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
- This early phase I trial tests the safety and how well N-803 works in treating patients with synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) that is growing, spreading, or getting worse (progressive) after being treated with adoptive cellular therapy (ACT) using T-cell receptor therapy (T-CRT). Synovial sarcoma is a rare, slow-growing cancer that affects the soft tissues, like muscles or ligaments near the joints.
- 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 18 to 80
You may be able to join if
- Patients must have histologically or cytologically confirmed Synovial Sarcoma (SS) and/or Myxoid/Round Cell Liposarcoma (MRCL) who have progressed...
- Patients must have been treated with a TCR-T product that can be assessed per medical history and/or discretion of the principal investigator. This...
- Patients must have measurable disease according to RECIST v1.1. See Appendix A for RECIST v1.1 criteria.
- Patients must have shown clinical benefit on at least one scan post ACT using TCR-T, (SD, PR, CR), as determined by the treating investigator.
- Patients must be aged ≥ 18 to 80 at time of registration.
You likely can't join if
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception...
- Any medical diagnosis that would prevent the donation of WBCs or patients whom in the opinion of the investigator should not donate WBCs.
- Patients with high risk of bleeding, as determined by treating investigator. Note: If patients are on anticoagulants, the investigator will determine...
- Patients with illnesses or conditions that would prevent them from taking blood thinners or patients whom in the opinion of the investigator should...
- Patients who have received other IL-15 treatments since receiving TCR-T cells to the start of study treatment (C1D1). Note: Prior growth factors are...
- Patients with new or progressing brain metastases. Note: Patients with treated brain metastases that are stable in the opinion of the treating...
See the full eligibility criteria
Who can join
- Patients must have histologically or cytologically confirmed Synovial Sarcoma (SS) and/or Myxoid/Round Cell Liposarcoma (MRCL) who have progressed after ACT using TCR-T.
- Patients must have been treated with a TCR-T product that can be assessed per medical history and/or discretion of the principal investigator. This includes the FDA approved Afamitresgene autoleucel but also other...
- Patients must have measurable disease according to RECIST v1.1. See Appendix A for RECIST v1.1 criteria.
- Patients must have shown clinical benefit on at least one scan post ACT using TCR-T, (SD, PR, CR), as determined by the treating investigator.
- Patients must be aged ≥ 18 to 80 at time of registration.
- Patients must have a performance status of \>70% on the Karnofsky Scale (see Appendix A) or \< 2 on the ECOG Performance Scale (see Appendix B).
- Patients must be able to undergo leukapheresis per institutional standards. For patients receiving leukapheresis at the Rube Walker Blood Center, see Appendix F for reference document guidance and Rube Walker Blood...
- Patients must have adequate organ and bone marrow function as defined below within screening window of 28 days up until Pre-Dose Leukapheresis: Laboratory Test Value Absolute Neutrophil Count (ANC) ≥ 1,000/mcL\ \...
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
- POCBP must have a negative pregnancy test during screening and per the study schedule. See Study Procedures in Section 5 for more information.
- Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements.
What rules you out
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia, neuropathy and other non-significant adverse events per...
- Any medical diagnosis that would prevent the donation of WBCs or patients whom in the opinion of the investigator should not donate WBCs.
- Patients with high risk of bleeding, as determined by treating investigator. Note: If patients are on anticoagulants, the investigator will determine if patient can continue anticoagulants throughout the study, or if...
- Patients with illnesses or conditions that would prevent them from taking blood thinners or patients whom in the opinion of the investigator should not take blood thinners.
- Patients who have received other IL-15 treatments since receiving TCR-T cells to the start of study treatment (C1D1). Note: Prior growth factors are allowed per treating investigator discretion (i.e. erythropoietin...
- Patients with new or progressing brain metastases. Note: Patients with treated brain metastases that are stable in the opinion of the treating investigator are eligible.
- Known significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater, see Appendix C), myocardial infarction within 3 months prior to Pre-Dose Leukapheresis, unstable...
- Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to N-803 or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric...
- Participants who, in the opinion of the investigator, are unable to safely or feasibly receive subcutaneous injections of N-803. Examples include:
- Absence of suitable subcutaneous tissue for injection (e.g., due to cachexia, scarring, or anatomical limitations).
- Known history of allergic reactions attributed to compounds of similar chemical or biologic composition to N-803, or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized...
- Active skin conditions or infections at potential injection sites.
- Physical or psychological inability to tolerate subcutaneous injection procedures (e.g., severe needle phobia, movement disorders).
- Medical contraindications to subcutaneous administration (e.g., bleeding disorders, severe dermatologic conditions).
- Any other factors that, in the judgment of the investigator, would interfere with safe and feasible administration of subcutaneous injections.
- Major surgical procedure (as defined in Appendix E, e.g., GI surgery, removal or biopsy of brain metastasis), other than for diagnosis or known need for a major surgical procedure while on study treatment. Note...
- Systemic autoimmune disease currently requiring treatment (e.g., lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). The patient must have been off treatment...
- History of organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other...
- Use of physiologic doses of systemic steroid replacement is permitted at doses of ≤ 10 mg/day of prednisone (or equivalent, e.g., dexamethasone 1.5 mg, methylprednisolone 8 mg, or hydrocortisone 40 mg).
- Local steroids, including topical steroids (e.g., hydrocortisone, clobetasol), nasal steroids (e.g., fluticasone, mometasone), or inhaled steroids (e.g., budesonide, beclomethasone).
- Limited courses (\< 1 week) of systemic steroids (≤ 10 mg/day of prednisone or equivalent) (e.g, in patients with exacerbations of reactive airway disease or anaphylaxis in patients who have known contrast allergies).
- Immunosuppressive treatments to optimally manage immune-related AEs as clinically indicated
- Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the patient at high risk for treatment-related complications.
- Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:
- Hypertension that is not controlled on medication
- Ongoing or active infection requiring systemic treatment including:
- Known active infection with acute or chronic hepatitis B or C, known active human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome
- Exception: uncomplicated urinary tract infections (or sinus infections and are on antibiotics)
- (AIDS)-related illness
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen except the following:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- In situ cervical cancer that has undergone potentially curative therapy - Patient is pregnant or nursing. Note: Pregnant patients are excluded from this study because N-803 is an interleukin-15 (IL-15) receptor agonist...
- Other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.
- Patients who need to be on concurrent anticancer treatment (e.g., chemotherapy, immunotherapy, cytokine therapy [except erythropoietin]) throughout participation in the study.
- Patients who have had prior use of narrow therapeutic index drugs that are substrates of major CYP450 enzymes within 14 days of first study drug administration per discretion of the treating investigator, including but...
- Tacrolimus
- Cyclosporine
- Sirolimus
- Everolimus
- Warfarin
- Phenytoin
- Midazolam
- Tamoxifen
- Codeine
- Erlotinib
- Patients who have had prior use concomitant medications that prolong the QT/QTc interval within 14 days of first study drug administration visit per discretion of the treating investigator.
- Patients who have had prior biologic therapies or chemotherapy within 28 days of Pre-Dose Leukapheresis visit, or radiation therapy within 14 days of Pre-Dose Leukapheresis visit. Patient must have reviewed and signed...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, 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.