IFN-γ Combined With T Cells in the Treatment of Refractory Malignant Pleural Effusion and Ascites

NCT05268172 | Recruiting Phase 1

• 1 other identifier: 1362566548
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pleural Effusion, Malignant

Outcome Measures

Primary Outcomes (1)

• 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

  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

  The tumor shrinks or stabilizes for a certain period of time，Lasts at least 4 weeks

• Objective response rate

  8 weeks

• Molecular markers for efficacy prediction

  8 weeks

• Overall survival

  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 from any cause as assessed by the investigator at each treatment period

Study Arms (1)

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.

Drug: IFN-γ and CIK cells, Tcm cells or CAR T cells

Interventions

IFN-γ and CIK cells, Tcm cells or CAR T cells DRUG

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.

IFN- Y combined with T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead
• Sichuan University: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• Hunan Cancer Hospital: collaborator
• West China Hospital: collaborator
• Wuxi People's Hospital: collaborator
• Shenzhen Second People's Hospital: collaborator

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• quan liu, doctor

  Affiliated Hospital of Jiangnan University

  PRINCIPAL INVESTIGATOR

• liu quan, doctor

  Affiliated Hospital of Jiangnan University

  STUDY DIRECTOR

Central Study Contacts

liu quan, doctor

CONTACT

15995299079; Quanliu.lq@outlook.com

jiang li qing, postgraduate

CONTACT

15261479578; jjiangliq@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: March 7, 2022
• Study Start: December 20, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)