A Clinical Study to Evaluate the Safety and Tolerability of SCT-001 CAR-T Cells in Patients with Recurrent and Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Peritoneal Cancer.

Plain English Summary

SCT-001 CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer is a Phase 1 clinical trial sponsored by Shanghai Gynecologic Oncology Group studying Ovarian Cancer, Fallopian Tube Carcinoma, Peritoneal Carcinoma. This trial tests a new type of cell therapy called SCT-001 CAR-T cells for patients with ovarian, fallopian tube, or peritoneal cancers that have returned or not responded to treatment. It is for adults diagnosed with these specific gynecologic cancers who have already tried standard treatments without success. Participation involves receiving the SCT-001 CAR-T cell therapy, either directly into the abdomen or into a vein, and regular check-ups to monitor safety and effectiveness. Alternative treatments may include further chemotherapy, targeted therapy, or palliative care, depending on the patient's specific situation and previous treatments. The trial aims to enroll 24 participants.

Official Summary

This study is an open-label, dose-escalation, investigator-initiated phase I interventional clinical study. To evaluate the safety, tolerability and preliminary efficacy of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer, and to explore the pharmacokinetic characteristics, biomarker changes and immunogenicity of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer. In this study, two trial cohorts were set up, cohort 1 was the intraperitoneal route of administration, and the subjects enrolled in cohort 1 needed to meet the conditions for intraperitoneal administration ((1) the subject had a large amount of ascites, (2) the subject was suitable for peritoneal catheterization, (3) the subject had no severe abdominal adhesions, and (4) the subject agreed to undergo intraperitoneal surgical catheterization for intraperitoneal administration); Cohort 2 is the intravenous route.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with confirmed epithelial ovarian, fallopian tube, or peritoneal cancer that has returned or is resistant to treatment. Patients must have tumors that express a specific marker called TAG-72 and have at least one measurable tumor lesion. Individuals with severe organ dysfunction, active infections, uncontrolled central nervous system metastases, or a history of certain autoimmune or cardiovascular diseases cannot participate. Patients must have a good performance status (ECOG 0-2 or KPS >=70) and adequate organ function (blood counts, kidney, liver, and clotting). This trial is studying Ovarian Cancer, Fallopian Tube Carcinoma, Peritoneal Carcinoma, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how often serious side effects occur and the overall safety of the SCT-001 CAR-T cell therapy, helping doctors understand how to use it safely. The specific primary outcome measures are: Incidence of dose limiting toxicities (DLTs) (28 days); Incidence of adverse events (24 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial addresses a critical need for new treatments for recurrent and refractory gynecologic cancers, offering a novel cell-based therapy approach where options are limited. This research targets Ovarian Cancer, Fallopian Tube Carcinoma, Peritoneal Carcinoma, where improved treatment options are needed.

Investor Insight

This Phase 1 trial represents an early-stage investment in a potentially groundbreaking CAR-T therapy for a significant unmet need in gynecologic oncology, with a small initial enrollment suggesting a Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific risks and benefits of CAR-T therapy, especially the two different ways it can be given (intraperitoneal vs. intravenous). Be prepared for regular hospital visits for treatment, monitoring, and potential side effect management. Understand that this is an early-phase trial, meaning the treatment is still being tested for safety and effectiveness. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 24 participants

Interventions

• BIOLOGICAL: SCT-001 CAR-T cells — SCT-001 CAR-T cells are autologous-derived CAR-T cell products, which transduce second-generation CAR targeting TAG-72 into patient autologous T cells by lentiviral transfection, and knock out immunosuppressive related genes by CRISPR/Cas9 technology to enhance the anti-tumor function of CAR-T cells.

Primary Outcomes

• Incidence of dose limiting toxicities (DLTs) (28 days)
• Incidence of adverse events (24 months)

Secondary Outcomes

• Change of CAR Copies (12 months)
• Objective response rate (12 months)

Full Eligibility Criteria

Inclusion Criteria:

* Subjects must meet all of the following criteria for admission to this study:

Age≥ 18 years old;

* ECOG performance status score: 0\~2 points or KPS score≥70 points;
* Relapsed or refractory epithelial ovarian, fallopian tube and peritoneal cancer confirmed by histology or cytology and have failed, are intolerant or have no standard treatment after standard therapy;
* Tumor tissue specimens or tumor samples can be obtained by tumor biopsy and other methods;
* Immunohistochemistry (IHC) staining confirmed that the tumor cells had positive TAG-72 expression (positive definition: \>). IHC staining intensity of 1% tumor cells ≥2+);
* Estimated survival time of more than 3 months;
* At least one evaluable tumor lesion according to RECIST 1.1;
* Prior to treatment, major organ function met the following criteria (no blood transfusion, long-acting EPO, long-acting G-CSF therapy within 14 days prior to study drug administration, in the case of short-acting EPO, short-acting G-CSF, this criterion can be shortened to 7 days):
* complete blood count: Absolute neutrophil count (ANC) ≥1.5×109/L,, Absolute lymphocyte count (ALC) ≥ 0.5×109/L; hemoglobin (HGB) ≥ 80 g/L; Platelets (PLT) ≥ 75×109/L;
* Renal: serum creatinine ≤1.5× upper limit of normal range (ULN);
* Liver: total bilirubin ≤ 1.5× ULN (including patients with liver metastases or liver cancer), AST and ALT ≤ 2.5× ULN (liver metastases ≤5×ULN);
* Coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5× ULN, partially activated thromboplastin time (APTT) ≤ 1.5× ULN;
* Must be using adequate contraception during the study and for 6 months after the end of the study, have a negative serum pregnancy test within 7 days prior to proposed enrollment in the study, and must be a non-lactating subject.

Exclusion Criteria:

* Subjects who meet any of the following criteria will not be admitted to this study:
* Those who are allergic to any component of SCT-001 CAR-T cell injection;
* Received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc., or participated in other clinical trials and received 5 half-lives of therapeutic drugs within 4 weeks prior to the first use of the study drug (4 weeks or 5 half-lives, whichever is shorter);
* Received treatment with traditional Chinese medicine or modern Chinese medicine preparations with anti-tumor indications in the label within 14 days before the first dose;
* The adverse reactions of previous anti-tumor therapy have not recovered to NCI CTCAE v5.0 grade evaluation ≤ grade 1 (except for toxicity that the investigator judges has no safety risk such as alopecia);
* Surgical procedure within 4 weeks prior to treatment or has not fully recovered from any previous invasive procedure;
* Central nervous system metastases or meningeal metastases with clinical symptoms, or other evidence that the subject's central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for enrollment;
* Those with active infection (NCI CTCAE v5.0≥ grade 2) or any other person with suspected risk of infection as assessed by the investigator;
* Has a history of autoimmune disease, immunodeficiency, including a positive HIV test, or has other acquired, congenital immunodeficiency diseases, or has a history of organ transplantation;
* Subjects with active hepatitis B or active hepatitis C;
* Those who have used immune cell therapy in the past;
* History of severe cardiovascular disease, such as severe cardiac rhythm or conduction abnormalities (ventricular arrhythmia requiring clinical intervention, II.\~III. degree atrioventricular block, etc.), myocardial infarction, history of coronary artery bypass surgery, heart failure, New York College of Cardiology (NYHA) grade II or above, left ventricular ejection fraction (LVEF) ≤50% and thrombosis found, male QTcF \>450msec or female QTcF \>470msec, etc.;
* Subjects with a history of severe cerebrovascular diseases such as stroke;
* Need to combine with other anti-tumor therapies (including various radiotherapy, chemotherapy, immunotherapy, targeted therapy, traditional Chinese medicine therapy, etc.);
* Previous clear history of neurological or psychiatric disorders, including epilepsy or dementia;
* In the opinion of the investigator, the subject has other reasons that make it unsuitable to participate in this clinical study.

Trial Locations

• Zhongshan Hospital Fudan University, Shanghai, Shanghai Municipality, China

Frequently Asked Questions

Related Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer
• Gynecologic Cancers
• Recurrent Cancer
• Refractory Cancer
• Advanced Cancer
• Epithelial Cancer
• TAG-72 Positive Tumors
• Immunotherapy

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