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New treatment option for B7-H3-positive Advanced Malignant Solid Tumors Advanced Primary...
Official title MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06912152
What this study is testing
What is MT027 CAR-T cells?
MT027 CAR-T cells is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for b7-h3-positive advanced malignant solid tumors advanced primary peritoneal tumors or secondary abdominal metastatic malignant solid tumors.
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, single-arm phase I dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of MT027 in patients with advanced primary peritoneal malignancies or abdominal metastases secondary to malignant solid tumors. The study primarily focuses on determining the maximum tolerated dose and recommended phase II dose through sequential cohort dose escalation, while secondarily characterizing the pharmacokinetic parameters and collecting initial efficacy data regarding tumor response.
- 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 70
You may be able to join if
- Patients must meet all of the following to be enrolled in this study:
- Voluntarily participate in this study and provide a signed and dated written informed consent form before undergoing any study-specific procedures...
- Aged 18-70 years (inclusive), regardless of gender;
- Diagnosed with primary malignancy confirmed by pathology and/or histology (with complete pathological report provided), including:Advanced solid...
- Clear systemic treatment plan for primary and metastatic lesions, with no anticipated changes during the study;
You likely can't join if
- 1\. Known allergy to the investigational drug or its excipients; 2. Contraindications to peritoneal puncture or deemed unlikely to benefit from...
See the full eligibility criteria
- Patients must meet all of the following to be enrolled in this study:
- Voluntarily participate in this study and provide a signed and dated written informed consent form before undergoing any study-specific procedures, sampling, or analyses;
- Aged 18-70 years (inclusive), regardless of gender;
- Diagnosed with primary malignancy confirmed by pathology and/or histology (with complete pathological report provided), including:Advanced solid tumors that have failed ≥2 lines of prior standard therapy;Advanced solid...
- Clear systemic treatment plan for primary and metastatic lesions, with no anticipated changes during the study;
- Confirmed peritoneal metastasis via biopsy, cytology, CT, or prior evidence;
- Enhanced CT shows intraperitoneal space-occupying lesions with ≥1 measurable lesion (per iRECIST criteria); or evaluable malignant peritoneal effusion via ultrasound (per WHO criteria);
- Willingness to provide recent FFPE tissue samples, pathological slides (8 consecutive unstained slides), or ascites tumor cells for B7-H3 expression testing, with confirmed B7-H3 positivity;
- No intraperitoneal drug injections (including hyperthermic intraperitoneal chemotherapy) within 1 month before signing the informed consent, except diagnostic paracentesis;
- Expected survival ≥3 months;
- ECOG performance status (PS) score of 0-2;
- Laboratory results during screening meeting the following criteria: Blood tests (within 14 days): WBC ≥3.0×10\^9/L; ANC ≥1.5×10\^9/L; Lymphocytes ≥0.8×10\^9/L; Platelets ≥90×10\^9/L; Hemoglobin ≥90 g/L (transfusions or...
- Recovery of prior systemic treatment toxicity to ≤Grade 1 or baseline (except alopecia);
- Fertile males and females must agree to use contraception from informed consent until 180 days post-last MT027 cell infusion.
- 1\. Known allergy to the investigational drug or its excipients; 2. Contraindications to peritoneal puncture or deemed unlikely to benefit from intraperitoneal therapy; 3. MSI-H/dMMR colorectal cancer patients not...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.