- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060796
Study of CXCR5 Modified EGFR Targeted CAR-T Cells for Advanced NSCLC
A Single-arm, Open-label, Phase I Study to Evaluate the Safety and Efficacy of CXCR5 Modified EGFR Chimeric Antigen Receptor Autologous T Cells in EGFR-positive Patients With Advanced Non-small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
-
Guangzhou, China, 510260
- Recruiting
- Second Affiliated Hospital of Guangzhou Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All subjects or legal guardians must sign the informed consent form approved by the ethics committee in writing before starting any screening procedure;
- 18 Years to 75 Years, Histologically or cytologically confirmed Routine treatment of patients with advanced non-small cell lung cancer(Including TKI treatment failure patients);
- After the signature of the informed consent and prior to the collection of a single nuclear cell, the immuno- histochemical test must determine that the expression of EGFR in the tumor site of the patient reaches the positive standard and the score is 2 + or more;
- Pathological results suggest that CXCL13 factor positive rate ≥ 10 %;
- According to RECIST 1.1. The patient has at least one tumor lesion that can be measured (Results available within one month prior to screening period);
- Expected survival time ≥ 12 weeks;
- The Eastern oncology group strength status score (ECOG) was 0-1;
- Patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters: Serum creatinine≤ 1.6 mg/ml or the creatinine clearance ≥ 40 ml/min/1.73m. Total bilirubin < 1.5 times upper limits of normal;
- The hemodynamics determined by echocardiography or multichannel radionuclide angiography(MUGA) are stable and the left ventricular ejection fraction (LVEF)≥50%;
- Have sufficient bone marrow reserves (subjects can meet this requirement through blood transfusion), defined as: The number of white blood cells should not be less than 2 × 10^9/L;Platelet≥100 x 10^9/L; Hemoglobin ≥100 g/L;
If the patient uses the following drugs, the following conditions must be met:
Glucocorticoid: The therapeutic dose of glucocorticoid must be stopped 2 weeks before the EGFR CAR-T infusion. However, the following physiological replacement doses of glucocorticoids are allowed: 12 mg/m2 / dihydrogenated cortisone or equivalent; Immunosuppressive drugs: any immunosuppressive drugs must be stopped before they are selected for 4 weeks; Stop using granulocyte colony factor a week before plasmaphoresis.
- Women of childbearing age and all male subjects must agree to use effective contraceptive methods for at least 52 weeks after EGFR CAR-T infusion, and until two consecutive PCR tests show that CAR-T cells are no longer present in the body.
Exclusion Criteria:
- Patients who have previously received any gene therapy product treatment, including CAR-T treatment;
- Patients with uncontrolled hypertension (> 160/95), unstable coronary artery disease confirmed by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure(>New York Heart Association Class II) or myocardial infarction within 6 months before cell infusion;
- Patients with severe liver and kidney dysfunction or consciousness disorders;
- Patients who had undergone antitumor chemotherapy other than lymphocyte clearance chemotherapy within 14 days before the EGFR CAR-T infusion;
- Screening of patients who had received other research drugs within 30 days before infusion;
- Patients undergoing radiotherapy and TKI treatment within 2 weeks before infusion ;
- Patients with active hepatitis B: HBVDNA >1000 cps/ml;
- Patients with HIV antibody, hepatitis C antibody, syphilis spirocyte positive;
- Patients with The sputum smear and tuberculosis infection T cell test positive;
- Patients with Interstitial lung disease or pneumonia;
- Patients with acute life-threatening bacteria, viruses or fungal infections that have not yet been controlled(for example, before transfusion ≤ 72 hours of blood culture positive);
- Patients with central nervous system metastasis (after cerebral metastasis treatment is stable for more than 4 weeks and patients with asymptomatic brain metastasis do not need treatment), pericardial metastasis accompanied by a large amount of pericardial effusion;
Patients with a previous or concurrent second tumor, with the following exceptions:
Adequate treatment of basal or squamous cell carcinoma(adequate wound healing prior to entry into the study);In situ cancer of the cervix or breast cancer with no signs of recurrence at least three years prior to the study following curable treatment; The primary malignant tumor has been completely removed and has been completely relieved for 5 years.
- Pregnant or lactating women;
- Patients with history of T cell tumors or present with the disease.
- Having autoimmune or inflammatory disorders of active nerves (such as Guillian-Barre syndrome, amyotrophic lateral sclerosis);
- The researchers believe that other circumstances such as compliance should not be involved in this clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EGFR CAR-T
Group: 3 dose levels
|
The first dose group: 0.5 × 10^6/kg CAR positive T cells; The second dose group: 1.58 × 10^6/ kg CAR positive T cells; The third dose group: 5 × 10^6/kg CAR positive T cells.
The above dose allows a 20 % error; For subjects with body weight greater than 60 kg, the number of cells can only be calculated according to 60 kg of body weight.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time Frame: In CAR-T cells infusion, up to 52 weeks.
|
The type, frequency, severity, and duration of adverse events as a result of EGFR CAR T cells infusion will be summarized.
|
In CAR-T cells infusion, up to 52 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: In CAR-T cells infusion, up to 52 weeks.
|
Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1) assessed by MRI or CT.
ORR is the percentage of patients at Complete Response (CR) or Partial Response (PR) (according to independent review), prior to progression or further anti-cancer therapy.
|
In CAR-T cells infusion, up to 52 weeks.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZZBGCART-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells
-
Sun Yat-sen UniversityGuangzhou Bio-gene Technology Co., Ltd.Unknown
-
Southwest Hospital, ChinaRecruiting
-
The First Affiliated Hospital of Soochow UniversityRecruitingRelapsed/Refractory B-cell Non-Hodgkin's LymphomaChina
-
Innovative Cellular Therapeutics Co., Ltd.UnknownLymphoma, B-Cell | Leukemia, B-CellChina
-
Hebei Senlang Biotechnology Inc., Ltd.Tongji HospitalRecruiting19 and 22+ B Cell Hematologic Tumors | 19 and 20+ B Cell Hematologic TumorsChina
-
PersonGen BioTherapeutics (Suzhou) Co., Ltd.Anhui Provincial HospitalRecruitingCAR | Malignant TumorsChina
-
Xuanwu Hospital, BeijingBeijing Mario Biotech Company; Hebei Senlang BIotech Company; Beijing HuiNengAn...RecruitingGlioma | Malignant Glioma of Brain | Recurrence TumorChina
-
The First Affiliated Hospital with Nanjing Medical...UnknownLymphoma, B-Cell | Leukemia, B-cellChina
-
PersonGen BioTherapeutics (Suzhou) Co., Ltd.Unknown
-
PersonGen BioTherapeutics (Suzhou) Co., Ltd.Anhui Provincial HospitalRecruiting