Ovarian CancerPhase 1NCT06846424
SCT-001 CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer
A Phase 1 study testing SCT-001 CAR-T cells in people with Ovarian Cancer and Fallopian Tube Carcinoma, run by Shanghai Gynecologic Oncology Group at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Carcinoma, Peritoneal Carcinoma
- What is being tested?
- SCT-001 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2030
- Phase
- Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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+);
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- 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.
Who cannot join
- 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;
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- 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 and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Rongyu Zang Doctor, zang.rongyu@zs-hospital.sh.cn
About this study
Official title: 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.
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.
- Being tested
- SCT-001 CAR-T cells
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCT-001 CAR-T cellsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| SCT-001 CAR-T intraperitoneal route of administration | Experimental | Patients receive SCT-001CAR-T cells via IP administration with or without lymphodepletion. Receives: Biological: SCT-001 CAR-T cells |
| SCT-001 CAR-T intravenous route of administration | Experimental | Patients receive SCT-001CAR-T cells via IV administration with or without lymphodepletion. Receives: Biological: SCT-001 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs)
The incidence of of DLT event, which is defined as toxic events related to SCT-001 CAR-T cell injection that occur within the DLT observation period (28 days after CAR-T cell injection), including general adverse events graded according to NCI CTCAE v5.0, cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS).
Measured: 28 days
Incidence of adverse events
Toxicity within 24 months after CAR-T cell injection will be graded according to the NCI CTCAE v5.0.
Measured: 24 months
Secondary outcomes (2)
Change of CAR Copies
CAR Copies measured by qPCR (12 months after CAR-T infusion)
Measured: 12 months
Objective response rate
The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rongyu Zang, MD,PhD, Shanghai Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846424
- Sponsor's protocol ID
- SCT-001 CAR-T OC
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 26 Feb 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06846424
- Acronym / sponsor ID
- SCT-001 CAR-T OC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Gynecologic Oncology GroupOther government
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 26 Feb 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCT-001 CAR-T intraperitoneal route of administration | Experimental | Biological: SCT-001 CAR-T cellsPatients receive SCT-001CAR-T cells via IP administration with or without lymphodepletion. |
| SCT-001 CAR-T intravenous route of administration | Experimental | Biological: SCT-001 CAR-T cellsPatients receive SCT-001CAR-T cells via IV administration with or without lymphodepletion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (16 listed)
- 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);
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 |
|---|---|---|
| SCT-001 CAR-T cellsSCT-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. | Biological | SCT-001 CAR-T intraperitoneal route of administration, SCT-001 CAR-T intravenous route of administration |
Primary outcome
Incidence of dose limiting toxicities (DLTs)
Time frame: 28 days
The incidence of of DLT event, which is defined as toxic events related to SCT-001 CAR-T cell injection that occur within the DLT observation period (28 days after CAR-T cell injection), including general adverse events graded according to NCI CTCAE v5.0, cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS).
Incidence of adverse events
Time frame: 24 months
Toxicity within 24 months after CAR-T cell injection will be graded according to the NCI CTCAE v5.0.
2 secondary outcomes
Change of CAR Copies
Time frame: 12 months
Objective response rate
Time frame: 12 months
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 26 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCT-001 CAR-T cells in people with Ovarian Cancer and Fallopian Tube Carcinoma, run by Shanghai Gynecologic Oncology Group 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 14 inclusion and 16 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: opening soon, as of the sponsor's last update on 26 Feb 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (DLTs) (time frame: 28 days). The study lists 2 primary outcomes in all. 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 26 Feb 2025.