Cervical CancerPhase 2NCT05342506
Clinical Study on the Safety, Pharmacokinetics, and Efficacy of ScTIL (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Gynecological Malignancies
A Phase 2 study testing Toripalimab + ScTIL in people with Cervical Cancer and Ovarian Cancer, run by Peking Union Medical College Hospital.
Trial summary
The purpose of this study is to evaluate the safety and clinical efficacy of ScTIL in the treatment of recurrent or refractory cervical cancer, ovarian cancer and malignant trophoblastic tumor, to evaluate the pharmacokinetic characteristics of ScTIL, and to explore and analyze the changes of CTC, ctDNA and… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer, Ovarian Cancer, Malignant Trophoblastic Tumor
- What is being tested?
- Toripalimab + ScTIL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2022to 31 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75, female;
- Expected survival time > 3 months;
- Clinically diagnosed advanced gynecological tumors, including:
- cervical cancer;
- Ovarian cancer;
- Malignant trophoblastic tumor;
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- Patients who have received radical surgery ± adjuvant radiotherapy and chemotherapy, or who have disease progression or recurrence after receiving too many lines of radiotherapy and chemotherapy, who have been unable to be resected again or who cannot tolerate radiotherapy and chemotherapy;
- Patients with cervical and ovarian cancer have at least one measurable lesion according to RECIST version 1.1 standard; Patients with malignant trophoblastic tumor β HCG ≥ 5, with or without measurable lesions.
- Voluntarily accept peripheral blood apheresis ± surgical resection of fresh tumor tissue to obtain cells for cell preparation, and the proportion of peripheral blood PD-1 positive T cells in the total T cells is ≥ 18%. For patients who have received PD-1 monoclonal antibody treatment before screening, the proportion of peripheral blood PD1 positive T cells in the total T cells is ≥ 10%;
- The ECOG physical condition score is 0 to 1;
- Have sufficient bone marrow and organ functions:
- Blood system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days):
- Neutrophil count (ANC) ≥ 1.5 × one hundred and nine Platelet (PLT) ≥ 75 × 109/L Hemoglobin (HB) ≥ 90g / L Lymphocyte count (lym) ≥ 60% of the lower limit of normal value Lymphocyte subsets: proportion of B lymphocytes (CD19 +) in lymphocytes ≥ lower limit of normal value
- Liver function:
- Total bilirubin (TBIL) ≤ 1.5 × ULN Alanine aminotransferase (ALT) ≤ 3 × ULN Patients with liver metastasis or liver cancer: ≤ 5 × ULN Aspartic acid amino transfer (AST) ≤ 3 × ULN Patients with liver metastasis or liver cancer: ≤ 5 × ULN
- Renal function Creatinine ≤ 1.5 × ULN Coagulation function Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN
- Fertile women must agree to permanently use reliable contraceptive methods (hormone or barrier method or abstinence, etc.) with their partners during and after the trial; Women of childbearing age (as defined in Appendix 9) must have a negative blood or urine pregnancy test within 7 days before the first use of the study drug;
- The subjects must be informed of the study before the test and voluntarily sign a written informed consent.
Who cannot join
- Central nervous system metastasis or meningeal metastasis with clinical symptoms, or there is other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, which is not suitable for inclusion according to the judgment of the researcher;
- Subjects with a history of second malignancy within 5 years before signing the informed consent;
- Patients who had previously received PD-L1 mAb;
- Those who have active infection within 1 week before apheresis and currently need systematic anti infection treatment;
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before apheresis, Except for the following:
- Nitrosourea or mitomycin C were within 6 weeks before single harvest;
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- Oral fluorouracils and small molecule targeted drugs were taken 1 week before apheresis.
- Within 2 weeks before apheresis:
- Have received systemic glucocorticoid (prednisone > 10mg/day or equivalent dose of similar drugs) or other immunosuppressant treatment; Except for the following cases: local, eye, intra-articular, intranasal and inhaled glucocorticoids; Short term use of glucocorticoids for preventive treatment (e.g. prevention of contrast agent allergy);
- Used immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc;
- Within 4 weeks before apheresis:
- Have received other unlisted clinical research drugs or treatments;
- Have undergone major organ surgery (excluding puncture biopsy) or significant trauma, or need to undergo elective surgery during the trial;
- Used live attenuated vaccine;
- Currently suffering from interstitial lung disease;
- Had received PD-1 monoclonal antibody treatment and had ≥ grade 2 Irae; Or other immunotherapy with ≥ grade 3 Irae;
- Patients with active, or had, and relapsed autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., except for clinically stable autoimmune thyroid disease and well controlled type I diabetes.
- The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 and the evaluation is ≤ 1 (except for the toxicity without safety risk judged by the researchers such as hair loss).
- Have a history of immune deficiency, including HIV antibody test positive;
- Hepatitis B: the titer of HBsAg (+) and/or hepatitis B DNA is higher than that of the research center. And/or hepatitis C: anti HCV positive; And/or Treponema pallidum antibody positive;
- Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
- There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, ⅱ-ⅲ degree atrioventricular block, etc.
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 and above cardiovascular events occurred within 6 months before the first administration.
- New York Heart Association (NYHA) cardiac function grade ≥ grade II or left ventricular ejection fraction (LVEF) < 50%, or structural heart disease with high risk judged by other researchers;
- Clinically uncontrollable hypertension.
- Serous effusion beyond clinical control is not suitable to be included in the group according to the judgment of the researcher;
- Known alcohol or drug dependence;
- Mental disorder or poor compliance;
- Women with reproductive needs and pregnant or lactating women;
- There are other serious or uncontrolled systemic diseases, or other reasons that are not suitable to participate in this clinical study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Open, Single Arm, Phase IIa Clinical Study on the Safety, Pharmacokinetics, and Efficacy of ScTIL (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Gynecological Malignancies
The purpose of this study is to evaluate the safety and clinical efficacy of ScTIL in the treatment of recurrent or refractory cervical cancer, ovarian cancer and malignant trophoblastic tumor, to evaluate the pharmacokinetic characteristics of ScTIL, and to explore and analyze the changes of CTC, ctDNA and immunohistochemical Library of malignant tumor subjects before and after ScTIL treatment.Treatment will be terminated upon progressive disease, unacceptable toxicity, or withdrawal of consent. Subjects with responses other than progressive disease will receive subsequent rounds of ScTIL treatment.
Read the detailed description
The purpose of this study is to evaluate the safety and clinical efficacy of ScTIL in the treatment of recurrent or refractory cervical cancer, ovarian cancer and malignant trophoblastic tumor, to evaluate the pharmacokinetic characteristics of ScTIL, and to explore and analyze the changes of CTC, ctDNA and immunohistochemical Library of malignant tumor subjects before and after ScTIL treatment. Treatment will be terminated upon progressive disease, unacceptable toxicity, or withdrawal of consent. Subjects with responses other than progressive disease will receive subsequent rounds of ScTIL treatment.
The primary endpoint was objective response rate, defined as the proportion of patients with complete or partial response. Secondary endpoints were duration of response (time from the first evidence of response to disease progression or death, whichever came first), progression-free survival (time from the treatment initiation to disease progression or death, whichever came first), overall survival (time from the treatment initiation to the date of death or end of follow-up).
- Being tested
- Toripalimab + ScTIL
- Medical subject headings
- Uterine Cervical Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab + ScTILDrug
Toripalimab (80 mg iv) 24 hours before or concomitantly with ScTIL 3-5x10^9 intravenous reinfusion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Study subjects: Patient with cervical carcinoma Receives: Drug: Toripalimab + ScTIL |
| Cohort 2 | Experimental | Study subjects: Patient with ovarian cancer Receives: Drug: Toripalimab + ScTIL |
| Cohort 3 | Experimental | Study subjects: Patient with malignant trophoblastic tumor Receives: Drug: Toripalimab + ScTIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The proportion of patients with complete or partial response of cervical and ovarian cancer according to RECIST version 1.1, malignant trophoblastic tumor according to serum hCG level. Complete response was defined as a normal hCG level measured for 3 consecutive weeks. Partial response was defined as a ≥50% decrease in hCG level from baseline after 2 cycles.
Measured: 12 weeks
Secondary outcomes (4)
Disease control rate (DCR)
The percentage of cases with remission and stable lesions after treatment in the total number of evaluable cases.
Measured: 12 weeks
Duration of response (DOR)
The time from the first evidence of response to disease progression or death, whichever comes first.
Measured: 12 weeks
Progression-free survival
The time from the treatment initiation to disease progression or death, whichever comes first.
Measured: 12 weeks
Overall survival
The time from the treatment initiation to the date of death or end of follow-up.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start18 Apr 2022 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chineo Medicine (Beijing) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342506
- Sponsor's protocol ID
- XHKT-SCT006-2022
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open, Single Arm, Phase IIa Clinical Study on the Safety, Pharmacokinetics, and Efficacy of ScTIL (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT05342506
- Acronym / sponsor ID
- XHKT-SCT006-2022
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chineo Medicine (Beijing) Co., Ltd.
- Study start
- 18 Apr 2022 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 22 Apr 2022 (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.
The purpose of this study is to evaluate the safety and clinical efficacy of ScTIL in the treatment of recurrent or refractory cervical cancer, ovarian cancer and malignant trophoblastic tumor, to evaluate the pharmacokinetic characteristics of ScTIL, and to explore and analyze the changes of CTC, ctDNA and immunohistochemical Library of malignant tumor subjects before and after ScTIL treatment.Treatment will be terminated upon progressive disease, unacceptable toxicity, or withdrawal of consent. Subjects with responses other than progressive disease will receive subsequent rounds of ScTIL treatment.
Detailed description
The purpose of this study is to evaluate the safety and clinical efficacy of ScTIL in the treatment of recurrent or refractory cervical cancer, ovarian cancer and malignant trophoblastic tumor, to evaluate the pharmacokinetic characteristics of ScTIL, and to explore and analyze the changes of CTC, ctDNA and immunohistochemical Library of malignant tumor subjects before and after ScTIL treatment. Treatment will be terminated upon progressive disease, unacceptable toxicity, or withdrawal of consent. Subjects with responses other than progressive disease will receive subsequent rounds of ScTIL treatment.
The primary endpoint was objective response rate, defined as the proportion of patients with complete or partial response. Secondary endpoints were duration of response (time from the first evidence of response to disease progression or death, whichever came first), progression-free survival (time from the treatment initiation to disease progression or death, whichever came first), overall survival (time from the treatment initiation to the date of death or end of follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Toripalimab + ScTILStudy subjects: Patient with cervical carcinoma |
| Cohort 2 | Experimental | Drug: Toripalimab + ScTILStudy subjects: Patient with ovarian cancer |
| Cohort 3 | Experimental | Drug: Toripalimab + ScTILStudy subjects: Patient with malignant trophoblastic tumor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 and ≤ 75, female;
- Expected survival time > 3 months;
- Clinically diagnosed advanced gynecological tumors, including:
- Patients who have received radical surgery ± adjuvant radiotherapy and chemotherapy, or who have disease progression or recurrence after receiving too many lines of radiotherapy and chemotherapy, who have been unable to be resected again or who cannot tolerate radiotherapy and chemotherapy;
- Patients with cervical and ovarian cancer have at least one measurable lesion according to RECIST version 1.1 standard; Patients with malignant trophoblastic tumor β HCG ≥ 5, with or without measurable lesions.
Key exclusion criteria (30 listed)
- Central nervous system metastasis or meningeal metastasis with clinical symptoms, or there is other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, which is not suitable for inclusion according to the judgment of the researcher;
- Subjects with a history of second malignancy within 5 years before signing the informed consent;
- Patients who had previously received PD-L1 mAb;
- Those who have active infection within 1 week before apheresis and currently need systematic anti infection treatment;
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before apheresis, Except for the following:
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 |
|---|---|---|
| Toripalimab + ScTILToripalimab (80 mg iv) 24 hours before or concomitantly with ScTIL 3-5x10^9 intravenous reinfusion. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Objective response rate
Time frame: 12 weeks
The proportion of patients with complete or partial response of cervical and ovarian cancer according to RECIST version 1.1, malignant trophoblastic tumor according to serum hCG level. Complete response was defined as a normal hCG level measured for 3 consecutive weeks. Partial response was defined as a ≥50% decrease in hCG level from baseline after 2 cycles.
4 secondary outcomes
Disease control rate (DCR)
Time frame: 12 weeks
Duration of response (DOR)
Time frame: 12 weeks
Progression-free survival
Time frame: 12 weeks
Overall survival
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab + ScTIL in people with Cervical Cancer and Ovarian Cancer, run by Peking Union Medical College Hospital.
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 18 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Xiang (010-69156068, XiangY@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 12 weeks). 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 22 Apr 2022.