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New treatment option for Sarcoma
Official title Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas
ClinicalTrials.gov ID: NCT07066982
What this study is testing
What is CD146/HER2 CAR-T cells?
CD146/HER2 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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
- This is an open-label, non-randomized, multicenter Phase 1/2 trial evaluating a dual CAR-T cell therapy targeting CD146 and HER2 in patients with advanced sarcoma. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by sequential infusion of autologous CD146-specific and HER2-specific CAR-T cells.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 36 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 90
You may be able to join if
- Expected survival time ≥3 months;
- Diagnosis: Histologically or cytologically confirmed sarcoma (soft tissue or bone sarcoma), that is metastatic, locally advanced, or refractory to...
- Prior Treatment: Patients should have received and progressed on or not be candidates for standard first-line treatments. There is no limit on number...
- Age and Performance Status: Participants age 12 years and older (both adolescent and adult patients are eligible; for minors, legal guardian consent...
- Organ Function: Adequate organ function to undergo cytotoxic chemotherapy and cell transfer therapy, including: cardiac ejection fraction ≥50%...
You likely can't join if
- Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell therapy is excluded. Also exclude patients who received...
- Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell Infections: Active uncontrolled infection, including...
- Immunosuppression: Use of systemic immunosuppressive medications (such as chronic corticosteroids at \>10 mg prednisone daily or equivalent) within 7...
- Medical Comorbidities: Any significant uncontrolled medical condition that would, in the investigator's judgment, make the patient an unsuitable...
- Pregnancy/Breastfeeding: Women who are pregnant or breastfeeding are excluded due to unknown risks of the treatment to a fetus or infant. Female...
See the full eligibility criteria
- Expected survival time ≥3 months;
- Diagnosis: Histologically or cytologically confirmed sarcoma (soft tissue or bone sarcoma), that is metastatic, locally advanced, or refractory to standard therapy. This may include osteosarcoma, Ewing sarcoma...
- Prior Treatment: Patients should have received and progressed on or not be candidates for standard first-line treatments. There is no limit on number of prior lines of therapy, but at least one prior systemic therapy...
- Age and Performance Status: Participants age 12 years and older (both adolescent and adult patients are eligible; for minors, legal guardian consent is required). Upper age limit of \~75 years, or as determined by...
- Organ Function: Adequate organ function to undergo cytotoxic chemotherapy and cell transfer therapy, including: cardiac ejection fraction ≥50%; baseline oxygen saturation \>92% on room air; adequate bone marrow reserves...
- Tumor Antigen Expression: Expression of CD146 and/or HER2 in the tumor is recommended (as assessed by immunohistochemistry or flow cytometry on a tumor sample). Note: At least one of the target antigens (CD146 or HER2)...
- Consent: Ability to understand and provide written informed consent (or assent for minors with consent of legal guardian). Patients (or guardians) must be willing to comply with trial procedures and follow-up.
- Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell therapy is excluded. Also exclude patients who received any investigational drug, immunotherapy (e.g. checkpoint inhibitor), or...
- Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell Infections: Active uncontrolled infection, including active hepatitis B or C infection, or HIV infection with uncontrolled...
- Immunosuppression: Use of systemic immunosuppressive medications (such as chronic corticosteroids at \>10 mg prednisone daily or equivalent) within 7 days prior to leukapheresis. (Physiologic replacement doses of...
- Medical Comorbidities: Any significant uncontrolled medical condition that would, in the investigator's judgment, make the patient an unsuitable candidate for CAR-T therapy. For example: active autoimmune diseases...
- Pregnancy/Breastfeeding: Women who are pregnant or breastfeeding are excluded due to unknown risks of the treatment to a fetus or infant. Female participants of childbearing potential and male participants with partners...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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 study runs about 36 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.