Pleural Effusion, MalignantPhase 1NCT05268172
IFN-γ Combined With T Cells in the Treatment of Refractory Malignant Pleural Effusion and Ascites
A Phase 1 study testing IFN-γ and CIK cells, Tcm cells or CAR T cells in people with Pleural Effusion, Malignant, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
The purpose of this study was to evaluate the efficacy of IFN- Y combined with T cells in the treatment of refractory malignant pleural effusion and acties, using a multicenter, single-arm, open design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Malignant
- What is being tested?
- IFN-γ and CIK cells, Tcm cells or CAR T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2022to 30 Dec 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients: ≥18 years old;
- Gastric cancer, colon cancer, lung cancer, lymphoma and other tumors confirmed by histology or cytology. The guidelines recommend entry to clinical trials in accordance with the standard treatment progression recommended by each disease guideline;
- According to iRECIST criteria, the patient should have at least one target lesion with measurable diameter line (tumor lesion CT scan length ≥10 mm, lymph node lesion CT scan short diameter ≥15 mm, scan thickness ≥ 5 mm); Or an unevaluable lesion, including but not limited to pleural effusion, bone metastasis, etc;
- ECOG physical condition score: 0-3;
- Estimated survival ≥3 months;
- Good function of major organs, that is, relevant examination indexes within the first 14 days of randomization meet the following requirements:(1)Routine blood test: 1)Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); 2)Neutrophil count > 1.5×109/L; 3)Platelet count ≥ 90×109/L; (2)Biochemical examination: 1)Total bilirubin ≤ 1.5×ULN (upper limit of normal value); 2)Serum alanine aminotransferase (ALT) or AST ≤ 2.5×ULN; ALT or AST ≤ 5×ULN if liver metastasis was present; 3)Endogenous creatinine clearance ≥ 60 mL /min (Cockcroft-Gault formula); (3)Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%;
- Signed informed consent;
- Good compliance, family members agreed to cooperate with survival follow-up.
Who cannot join
- Participated in clinical trials of other drugs within four weeks;
- Patients have a history of other tumors, except cervical carcinoma in situ, treated squamous cell carcinoma or bladder epithelial tumor (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years prior to enrollment);
- Patients with cardiac clinical symptoms or diseases that are not well controlled, such as NYHA grade 2 or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, and clinically significant ventricular or ventricular arrhythmias requiring treatment or intervention；
- For female subjects: surgically sterilized, postmenopausal, or have agreed to use a medically approved contraceptive during study treatment and for 6 months after the study treatment period; Serum or urine pregnancy tests must be negative during the 7 days prior to study enrollment and must be non-lactation. Male subjects: patients who are surgically sterilized or who have agreed to use a medically approved contraceptive during and for 6 months after the study treatment period；
- Patients with active tuberculosis, bacterial or fungal infection (grade ≥2 of NCI-CTC, 3rd edition); Have HIV infection, HBV infection, HCV infection；
- Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders;
- The subject has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism); Subjects with vitiligo or asthma in complete remission during childhood without any intervention as adults could be included; Subjects with asthma requiring medical intervention with bronchodilators were excluded)；
- According to the judgment of the researcher, there are serious concomitant diseases that endanger the patient's safety or affect the patient's ability to complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000
劝 刘, 15995299079
About this study
Official title: Single-arm Open Multicenter Study of IFN-γ Combined With T Cells in the Treatment of Refractory Malignant Pleural Effusion Tumors
The purpose of this study was to evaluate the efficacy of IFN- Y combined with T cells in the treatment of refractory malignant pleural effusion and acties, using a multicenter, single-arm, open design.
Read the detailed description
Malignant pleural effusion is a common complication of malignant tumor, which usually indicates that the patient has reached the advanced stage, and about 30-40% of the patients are stubborn and refractory cases. The lack of standard therapeutic drugs and protocols in clinical practice seriously affects the anti-tumor treatment effect, quality of life and survival time of patients, and the prognosis is poor. IFN-γ can significantly induce the high expression of the costimulatory molecule ICAM-1 on tumor cells, thereby enhancing the killing of TUMOR cells by T cells. Moreover, IFN-γ can enhance the activity of CAR T cells in the presence of PD-L1-PD-1 pathway, and significantly improve the therapeutic effect of T cells on solid tumors. IFN-γ is an approved clinical treatment with known side effects and well-established symptomatic treatment. Although CIK is not a clinically approved drug, it has been used on a large scale in China with good safety and has entered the medical insurance of some provinces and cities. Tcm is an improved CIK cell and has good safety. Many clinical studies have been carried out, and no serious toxic and side effects have been observed.
- Conditions
- Pleural Effusion, Malignant
- Being tested
- IFN-γ and CIK cells, Tcm cells or CAR T cells
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFN-γ and CIK cells, Tcm cells or CAR T cellsDrug
A 50ng/ mL IFN-γ solution was prepared, and the required volume of IFN-γ solution was calculated according to the final concentration of 5ng/ mL according to the volume of pleural fluid or ascites of the patient. CIK cells were injected 1.0-2.0×109 on the second day and review three days later.T cells and CAR T cells were selected sequentially according to the re-examination of pleural fluid or ascites.
| Study group | Role | What they receive |
|---|---|---|
| IFN- Y combined with T cells | Experimental | First, IFN-γ was combined with CIK cells. After three failed treatments, the CIK cells were replaced with T cells. After three failed treatments, CART cells were finally replaced. Receives: Drug: IFN-γ and CIK cells, Tcm cells or CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puncture-free Survival (PuFS)
Puncture-free Survival (PuFS) is a clinical endpoint used to measure the time duration during which a patient with a condition like malignant ascites or malignant pleural effusion remains free from needing a puncture procedure
Measured: Focusing on the time from the end of the T Cells treatment procedure to the next required drainage or death
Secondary outcomes (5)
Disease control rate
Proportion of patients who had a best response rating of complete response, partial response, or stable disease
Measured: The tumor shrinks or stabilizes for a certain period of time，Lasts at least 4 weeks
Objective response rate
Total response and partial response ratio
Measured: 8 weeks
Molecular markers for efficacy prediction
Prediction effect
Measured: 8 weeks
Overall survival
The last follow-up time of the lost patient; Patients who were still alive at the end of the study were at the end of follow-up
Measured: From the time of diagnosis of tumor to death from any cause，From initiation of study treatment until date of death from any cause, up to 100 months
Progression-free survival
From time of treatment to time of disease progression or death
Measured: From time of treatment to time of disease progression or death from any cause as assessed by the investigator at each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start20 Dec 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Effusion, MalignantStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan University, Zhejiang Provincial People's Hospital, Hunan Cancer Hospital, West China Hospital, Wuxi People's Hospital, Shenzhen Second People's Hospital
- Responsible party
- Sponsor
- Investigators
- quan liu, doctor, Principal investigator, Affiliated Hospital of Jiangnan Universityliu quan, doctor, Study director, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268172
- Sponsor's protocol ID
- 1362566548
- Status last verified
- May 2024
- First submitted
- 6 Dec 2021
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The associated efficacy is uncertain
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Open Multicenter Study of IFN-γ Combined With T Cells in the Treatment of Refractory Malignant Pleural Effusion Tumors
- ClinicalTrials.gov ID
- NCT05268172
- Acronym / sponsor ID
- 1362566548
- Conditions
- Pleural Effusion, Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Collaborators
- Sichuan University, Zhejiang Provincial People's Hospital, Hunan Cancer Hospital, West China Hospital, Wuxi People's Hospital, Shenzhen Second People's Hospital
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Mar 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 was to evaluate the efficacy of IFN- Y combined with T cells in the treatment of refractory malignant pleural effusion and acties, using a multicenter, single-arm, open design.
Detailed description
Malignant pleural effusion is a common complication of malignant tumor, which usually indicates that the patient has reached the advanced stage, and about 30-40% of the patients are stubborn and refractory cases. The lack of standard therapeutic drugs and protocols in clinical practice seriously affects the anti-tumor treatment effect, quality of life and survival time of patients, and the prognosis is poor. IFN-γ can significantly induce the high expression of the costimulatory molecule ICAM-1 on tumor cells, thereby enhancing the killing of TUMOR cells by T cells. Moreover, IFN-γ can enhance the activity of CAR T cells in the presence of PD-L1-PD-1 pathway, and significantly improve the therapeutic effect of T cells on solid tumors. IFN-γ is an approved clinical treatment with known side effects and well-established symptomatic treatment. Although CIK is not a clinically approved drug, it has been used on a large scale in China with good safety and has entered the medical insurance of some provinces and cities. Tcm is an improved CIK cell and has good safety. Many clinical studies have been carried out, and no serious toxic and side effects have been observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IFN- Y combined with T cells | Experimental | Drug: IFN-γ and CIK cells, Tcm cells or CAR T cellsFirst, IFN-γ was combined with CIK cells. After three failed treatments, the CIK cells were replaced with T cells. After three failed treatments, CART cells were finally replaced. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients: ≥18 years old;
- Gastric cancer, colon cancer, lung cancer, lymphoma and other tumors confirmed by histology or cytology. The guidelines recommend entry to clinical trials in accordance with the standard treatment progression recommended by each disease guideline;
- According to iRECIST criteria, the patient should have at least one target lesion with measurable diameter line (tumor lesion CT scan length ≥10 mm, lymph node lesion CT scan short diameter ≥15 mm, scan thickness ≥ 5 mm); Or an unevaluable lesion, including but not limited to pleural effusion, bone metastasis, etc;
- ECOG physical condition score: 0-3;
- Estimated survival ≥3 months;
Key exclusion criteria (8 listed)
- Participated in clinical trials of other drugs within four weeks;
- Patients have a history of other tumors, except cervical carcinoma in situ, treated squamous cell carcinoma or bladder epithelial tumor (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years prior to enrollment);
- Patients with cardiac clinical symptoms or diseases that are not well controlled, such as NYHA grade 2 or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, and clinically significant ventricular or ventricular arrhythmias requiring treatment or intervention；
- For female subjects: surgically sterilized, postmenopausal, or have agreed to use a medically approved contraceptive during study treatment and for 6 months after the study treatment period; Serum or urine pregnancy tests must be negative during the 7 days prior to study enrollment and must be non-lactation. Male subjects: patients who are surgically sterilized or who have agreed to use a medically approved contraceptive during and for 6 months after the study treatment period；
- Patients with active tuberculosis, bacterial or fungal infection (grade ≥2 of NCI-CTC, 3rd edition); Have HIV infection, HBV infection, HCV infection；
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 |
|---|---|---|
| IFN-γ and CIK cells, Tcm cells or CAR T cellsA 50ng/ mL IFN-γ solution was prepared, and the required volume of IFN-γ solution was calculated according to the final concentration of 5ng/ mL according to the volume of pleural fluid or ascites of the patient. CIK cells were injected 1.0-2.0×109 on the second day and review three days later.T cells and CAR T cells were selected sequentially according to the re-examination of pleural fluid or ascites. | Drug | IFN- Y combined with T cells |
Primary outcome
Puncture-free Survival (PuFS)
Time frame: Focusing on the time from the end of the T Cells treatment procedure to the next required drainage or death
Puncture-free Survival (PuFS) is a clinical endpoint used to measure the time duration during which a patient with a condition like malignant ascites or malignant pleural effusion remains free from needing a puncture procedure
5 secondary outcomes
Disease control rate
Time frame: The tumor shrinks or stabilizes for a certain period of time，Lasts at least 4 weeks
Objective response rate
Time frame: 8 weeks
Molecular markers for efficacy prediction
Time frame: 8 weeks
Overall survival
Time frame: From the time of diagnosis of tumor to death from any cause，From initiation of study treatment until date of death from any cause, up to 100 months
Progression-free survival
Time frame: From time of treatment to time of disease progression or death from any cause as assessed by the investigator at each treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No. The associated efficacy is uncertain
Related trials for Pleural Effusion, Malignant
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
RecruitingObservational study
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
Pleural Neoplasm
Recruiting
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
Malignant Pleural Effusions (Mpe), Medical Thoracoscopy
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.
quan liu, doctor principal investigator
Affiliated Hospital of Jiangnan University
liu quan, doctor study director
Affiliated Hospital of Jiangnan University
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 IFN-γ and CIK cells, Tcm cells or CAR T cells in people with Pleural Effusion, Malignant, run by Affiliated Hospital of Jiangnan 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 8 inclusion and 8 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 16 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact liu quan, doctor (15995299079, Quanliu.lq@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Puncture-free Survival (PuFS) (time frame: Focusing on the time from the end of the T Cells treatment procedure to the next required drainage or death). 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 16 May 2024.