Gynecological Solid TumorsNCT06904131
A Phase I Clinical Trial of CAR-T Cells for Advanced Gynecological Solid Tumors
A study testing Cell therapy with bispecific antibodies in people with Gynecological Solid Tumors, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
Trial summary
Screening patients who meet the criteria for peripheral blood mononuclear cell (PBMC) isolation and cell preparation. Based on the status of cell preparation and mutual agreement between the researcher and the participant, the date of reinfusion (Day 0) is determined. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Gynecological Solid Tumors
- What is being tested?
- Cell therapy with bispecific antibodies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with gynecological solid tumors diagnosed by histopathology, with tumor tissue sample MUC1 expression rate ≥50% or MSLN expression rate ≥50%, PD-L1 positive expression, and sample source within 2 years;
- Patients with advanced gynecological solid tumors who have failed standard treatment or are intolerant to such treatment and have no standard effective treatment options;
- Females aged 18 to 70 years (inclusive);
- Estimated survival time ≥ 3 months;
- ECOG performance status score of 0 to 1 at screening and baseline;
- Good organ and bone marrow function:
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- The researcher assesses sufficient bone marrow function to receive lymphocyte-depleting chemotherapy: Neutrophil count ≥1.5 × 10^9/L, lymphocyte count ≥0.5 × 10^9/L;
- Platelet count ≥90 × 10^9/L;
- Hemoglobin ≥90 g/L (no blood transfusion or no erythropoietin-dependent within 7 days);
- Total bilirubin ≤2 times the upper limit of normal value;
- Serum creatinine ≤1.5 times the upper limit of normal value;
- Transaminase (AST, ALT) ≤2.5 times the upper limit of normal value (if liver metastasis is present, 5 times the upper limit of normal value);
- International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5 times the upper limit of normal value;
- Pulmonary function: ≤ CTCAE grade 1 dyspnea and SaO2 ≥ 91% in room air;
- Cardiac function: Echocardiogram or radionuclide ventriculography (MUGA) assessment left ventricular ejection fraction (LVEF) ≥50% within 1 month of enrollment.
Who cannot join
- Participants who have undergone other anti-tumor treatments not allowed by the protocol within 1 month before CAR-T infusion (including radiotherapy, chemotherapy, small molecules, biological treatment, or immunotherapy, other research drugs);
- Participants who have previously received targeted therapy against MUC1 or MSLN, or cellular therapy, or any gene therapy products (including CAR-T cell therapy) or any T cell therapy at home or abroad;
- Pregnant or breastfeeding women;
- AIDS virus, syphilis seroreactivity positive; hepatitis B surface antigen positive, or hepatitis B core antibody positive and hepatitis B virus DNA copies higher than the detection limit or greater than or equal to 1000 copies/mL; or hepatitis C virus infection;
- Any uncontrollable active infection, coagulopathy, or any other major disease;
- Patients with active autoimmune diseases being treated, organ transplantation and other immune-related diseases, or long-term use of immunosuppressive drugs such as glucocorticoids: a. Glucocorticoids cannot be discontinued within 72 hours before CAR-T cell infusion; b. Immunosuppressive agents other than glucocorticoids cannot be discontinued ≥4 weeks before enrollment;
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- Patients with severe cardiopulmonary insufficiency, uncontrolled hypertension, any of the following cardiovascular disease histories within the past 6 months: III or IV heart failure defined by the New York Heart Association (NYHA), cardiac catheterization or stent, myocardial infarction, unstable angina, or other clinically significant heart disease;
- Patients with confirmed brain metastasis, or those with a history of or current central nervous system disease, such as epileptic seizures, cerebrovascular ischemia/hemorrhage, dementia, encephalopathy, or any autoimmune disease associated with the central nervous system;
- Patients with high risk of bleeding or perforation;
- Patients who underwent major surgery or significant trauma within 4 weeks before single collection;
- Patients with other malignant tumors within 3 years or concurrently (except for skin basal cell carcinoma, cervical/breast cancer in situ, etc.);
- Any other conditions deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200090
Xin Wu, 8613764046908, wuxin_fc@fudan.edu.cn
About this study
Official title: A Phase I Clinical Trial of MUC1-targeted CAR-T Cells with PD1 Nanobody MSLN Dual-target for Advanced Gynecological Solid Tumors
Screening patients who meet the criteria for peripheral blood mononuclear cell (PBMC) isolation and cell preparation. Based on the status of cell preparation and mutual agreement between the researcher and the participant, the date of reinfusion (Day 0) is determined. From Day -5 to Day -3, the participant receives a conditioning regimen with cyclophosphamide and antithymocyte globulin. After recovery for two days (Day -2 and Day -1), on Day 0, the participant receives reinfusion of BZE2203 (dose determined according to the dose-escalation requirements). The safety observation period lasts for 28 days, and clinical efficacy is assessed from Day 28 to Day 34. After comprehensive judgment, the second course of cell therapy is selected. Follow-up observations and evaluations are conducted once every three months, with follow-up visits once a year and telephone follow-ups once every two months.
Read the detailed description
This study is a single-arm, open-label, dose-escalation and expansion clinical trial. The study is divided into two phases: the dose-escalation phase and the dose-expansion phase.
The dose-escalation phase is designed with three predefined dose levels, following a "3+3 design" and progressing from low to high doses. The "3+3" dose-escalation scheme is as follows: if no dose-limiting toxicity (DLT) occurs in the three subjects at a given dose level during the observation period, the dose will be escalated to the next higher level. If one subject out of the initial three experiences DLT at a dose level, an additional three subjects will be enrolled at that dose level for further DLT observation. The dose level at which no more than one subject out of the final six subjects experiences DLT will be defined as the maximum tolerated dose (MTD).
The dose level for the expansion phase will be determined based on a comprehensive consideration of the occurrence of DLT and the efficacy results obtained, with the actual occurrence serving as the basis.
The safety of CAR-T therapy will be assessed by monitoring adverse events (AE) following cell therapy. The efficacy of CAR-T therapy will be evaluated by observing disease response following cell therapy. Blood samples will be collected before cell infusion and within one year after infusion to measure the number of CAR-T cells, CAR copy number, and PD-1 nanobody concentration, thereby evaluating the pharmacokinetics of CAR-T cells. Blood samples will also be collected before cell infusion and within 28 days after infusion to measure the concentrations of relevant cytokines, in order to assess the pharmacodynamic characteristics of CAR-T therapy.
During the study, blood samples used for the production of CAR-T cells will be transported to Shanghai Cell Therapy Group Pharmaceutical Technology Co., Ltd. After the production of CAR-T cells is completed, the cells will be shipped to the study sponsor, who will then infuse the CAR-T cells into the corresponding subjects.
- Conditions
- Gynecological Solid Tumors
- Being tested
- Cell therapy with bispecific antibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell therapy with bispecific antibodiesDrug
The dose-escalation phase is designed with three predefined dose levels, following a "3+3 design" and progressing from low to high doses. The "3+3" dose-escalation scheme is as follows: if no dose-limiting toxicity (DLT) occurs in the three subjects at a given dose level during the observation period, the dose will be escalated to the next higher level. If one subject out of the initial three experiences DLT at a dose level, an additional three subjects will be enrolled at that dose level for further DLT observation. The dose level at which no more than one subject out of the final six subjects experiences DLT will be defined as the maximum tolerated dose (MTD).
| Study group | Role | What they receive |
|---|---|---|
| Cell therapy group | Experimental | Screening patients who meet the criteria for peripheral blood mononuclear cell (PBMC) isolation and cell preparation. Based on the cell preparation status and mutual agreement between the researcher and the participant, the date of reinfusion (Day 0) is determined. On Days -5 to -3, the participant receives a conditioning regimen with cyclophosphamide and antithymocyte globulin. After recovery for two days (Days -2 and -1), on Day 0, the participant receives reinfusion of BZE2203 (dose determined according to the dose-escalation requirements). The safety observation period lasts for 28 days, and clinical efficacy is evaluated from Day 28 to Day 34. After comprehensive judgment, the second course of cell therapy is selected. Follow-up observations and evaluations are conducted once every three months, with follow-up visits once a year and telephone follow-ups once every two months. Receives: Drug: Cell therapy with bispecific antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: The time frame was from subject enrollment until one year after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start11 May 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- XIN WU, chief physician, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904131
- Sponsor's protocol ID
- FUOBGY-2025-39
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of MUC1-targeted CAR-T Cells with PD1 Nanobody MSLN Dual-target for Advanced Gynecological Solid Tumors
- ClinicalTrials.gov ID
- NCT06904131
- Acronym / sponsor ID
- FUOBGY-2025-39
- Conditions
- Gynecological Solid Tumors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 11 May 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Screening patients who meet the criteria for peripheral blood mononuclear cell (PBMC) isolation and cell preparation. Based on the status of cell preparation and mutual agreement between the researcher and the participant, the date of reinfusion (Day 0) is determined. From Day -5 to Day -3, the participant receives a conditioning regimen with cyclophosphamide and antithymocyte globulin. After recovery for two days (Day -2 and Day -1), on Day 0, the participant receives reinfusion of BZE2203 (dose determined according to the dose-escalation requirements). The safety observation period lasts for 28 days, and clinical efficacy is assessed from Day 28 to Day 34. After comprehensive judgment, the second course of cell therapy is selected. Follow-up observations and evaluations are conducted once every three months, with follow-up visits once a year and telephone follow-ups once every two months.
Detailed description
This study is a single-arm, open-label, dose-escalation and expansion clinical trial. The study is divided into two phases: the dose-escalation phase and the dose-expansion phase.
The dose-escalation phase is designed with three predefined dose levels, following a "3+3 design" and progressing from low to high doses. The "3+3" dose-escalation scheme is as follows: if no dose-limiting toxicity (DLT) occurs in the three subjects at a given dose level during the observation period, the dose will be escalated to the next higher level. If one subject out of the initial three experiences DLT at a dose level, an additional three subjects will be enrolled at that dose level for further DLT observation. The dose level at which no more than one subject out of the final six subjects experiences DLT will be defined as the maximum tolerated dose (MTD).
The dose level for the expansion phase will be determined based on a comprehensive consideration of the occurrence of DLT and the efficacy results obtained, with the actual occurrence serving as the basis.
The safety of CAR-T therapy will be assessed by monitoring adverse events (AE) following cell therapy. The efficacy of CAR-T therapy will be evaluated by observing disease response following cell therapy. Blood samples will be collected before cell infusion and within one year after infusion to measure the number of CAR-T cells, CAR copy number, and PD-1 nanobody concentration, thereby evaluating the pharmacokinetics of CAR-T cells. Blood samples will also be collected before cell infusion and within 28 days after infusion to measure the concentrations of relevant cytokines, in order to assess the pharmacodynamic characteristics of CAR-T therapy.
During the study, blood samples used for the production of CAR-T cells will be transported to Shanghai Cell Therapy Group Pharmaceutical Technology Co., Ltd. After the production of CAR-T cells is completed, the cells will be shipped to the study sponsor, who will then infuse the CAR-T cells into the corresponding subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cell therapy group | Experimental | Drug: Cell therapy with bispecific antibodiesScreening patients who meet the criteria for peripheral blood mononuclear cell (PBMC) isolation and cell preparation. Based on the cell preparation status and mutual agreement between the researcher and the participant, the date of reinfusion (Day 0) is determined. On Days -5 to -3, the participant receives a conditioning regimen with cyclophosphamide and antithymocyte globulin. After recovery for two days (Days -2 and -1), on Day 0, the participant receives reinfusion of BZE2203 (dose determined according to the dose-escalation requirements). The safety observation period lasts for 28 days, and clinical efficacy is evaluated from Day 28 to Day 34. After comprehensive judgment, the second course of cell therapy is selected. Follow-up observations and evaluations are conducted once every three months, with follow-up visits once a year and telephone follow-ups once every two months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with gynecological solid tumors diagnosed by histopathology, with tumor tissue sample MUC1 expression rate ≥50% or MSLN expression rate ≥50%, PD-L1 positive expression, and sample source within 2 years;
- Patients with advanced gynecological solid tumors who have failed standard treatment or are intolerant to such treatment and have no standard effective treatment options;
- Females aged 18 to 70 years (inclusive);
- Estimated survival time ≥ 3 months;
- ECOG performance status score of 0 to 1 at screening and baseline;
Key exclusion criteria (12 listed)
- Participants who have undergone other anti-tumor treatments not allowed by the protocol within 1 month before CAR-T infusion (including radiotherapy, chemotherapy, small molecules, biological treatment, or immunotherapy, other research drugs);
- Participants who have previously received targeted therapy against MUC1 or MSLN, or cellular therapy, or any gene therapy products (including CAR-T cell therapy) or any T cell therapy at home or abroad;
- Pregnant or breastfeeding women;
- AIDS virus, syphilis seroreactivity positive; hepatitis B surface antigen positive, or hepatitis B core antibody positive and hepatitis B virus DNA copies higher than the detection limit or greater than or equal to 1000 copies/mL; or hepatitis C virus infection;
- Any uncontrollable active infection, coagulopathy, or any other major disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell therapy with bispecific antibodiesThe dose-escalation phase is designed with three predefined dose levels, following a "3+3 design" and progressing from low to high doses. The "3+3" dose-escalation scheme is as follows: if no dose-limiting toxicity (DLT) occurs in the three subjects at a given dose level during the observation period, the dose will be escalated to the next higher level. If one subject out of the initial three experiences DLT at a dose level, an additional three subjects will be enrolled at that dose level for further DLT observation. The dose level at which no more than one subject out of the final six subjects experiences DLT will be defined as the maximum tolerated dose (MTD). | Drug | Cell therapy group |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: The time frame was from subject enrollment until one year after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
XIN WU, chief physician study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell therapy with bispecific antibodies in people with Gynecological Solid Tumors, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Wu (8613764046908, wuxin_fc@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: The time frame was from subject enrollment until one year after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.