Non Small Cell Lung CancerEarly Phase 1NCT05060796

Study of CXCR5 Modified EGFR Targeted CAR-T Cells for Advanced NSCLC

A Early Phase 1 study testing CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells in people with Non Small Cell Lung Cancer, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This study is a single arm, open-label, intravenous infusion of Anti- Epidermal growth factor receptor (EGFR) Chimeric Antigen Receptor (CAR) T cells modified by C-X-C Chemokine receptor type 5 (CXCR 5) in patients with advanced adult non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Non Small Cell Lung Cancer
What is being tested?: CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteChina
Study dates: 1 Sep 2019to 1 Nov 2034
Phase: Early 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 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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 ;

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhenfeng Zhang, MD, PhD contact

0086-020-39195966

zhangzhf@gzhmu.edu.cn

Bingjia He, MD contact

14748877800

China1 site, 1 recruiting

Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510260
Zhenfeng Zhang, MD, PhD, +862039195966, zhangzhf@gzhmu.edu.cn
Bingjia He, MD, +862039195965, 464677938@qq.com
Recruiting

Other trials in China

About this study

Official title: 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

Read the detailed description

In this study, the dose(number of cells by body weight) and time of infusion should be recorded in detail according to the dosage of slope climbing and single infusion. The safety of chimeric antigen receptor T(CAR-T) cells treatment was evaluated by observing the adverse events after cell therapy. The effectiveness of CAR-T treatment was initially assessed compared with the results of the patient's own previous standard treatment plan. Blood was collected before and within 12 months after infusion to detect the number and activity of CAR-T cells and evaluate the pharmacokinetic characteristics of CAR-T cells.

Conditions: Non Small Cell Lung Cancer
Being tested: CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cellsBiological
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.

Study groups in NCT05060796
Study group	Role	What they receive
EGFR CAR-T	Experimental	Group: 3 dose levels Receives: Biological: CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
The type, frequency, severity, and duration of adverse events as a result of EGFR CAR T cells infusion will be summarized.
Measured: In CAR-T cells infusion, up to 52 weeks.

Secondary outcomes (1)

Objective Response Rate (ORR)
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.
Measured: In CAR-T cells infusion, up to 52 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20191 Nov 2034

First posted29 Sep 2021
Study start1 Sep 2019
Primary completion1 Nov 2029 (estimated)
Study completion1 Nov 2034 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe 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: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05060796
Sponsor's protocol ID: ZZBGCART-014
Status last verified: Jun 2024
First submitted: 19 Sep 2021
Last updated: 25 Jun 2024
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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05060796
Acronym / sponsor ID: ZZBGCART-014
Conditions: Non Small Cell Lung Cancer
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 11 participants (estimated)
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
Study start: 1 Sep 2019 (actual)
Primary completion: 1 Nov 2029 (estimated)
Study completion: 1 Nov 2034 (estimated)
First posted: 29 Sep 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EGFR CAR-T	Experimental	Biological: CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cellsGroup: 3 dose levels

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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);

Key exclusion criteria (18 listed)

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;

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
CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cellsThe 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.	Biological	EGFR CAR-T

Primary outcome

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.

1 secondary outcome

Objective Response Rate (ORR)
Time frame: In CAR-T cells infusion, up to 52 weeks.

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 25 Jun 2024.
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.

Zhenfeng Zhang, MD, PhD contact

0086-020-39195966

zhangzhf@gzhmu.edu.cn

Bingjia He, MD contact

14748877800

Zhenfeng Zhang, MD, PHD principal investigator

Second Affiliated Hospital of Guangzhou Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 25 Jun 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Contact Zhenfeng Zhang, MD, PhD (0086-020-39195966, zhangzhf@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. (time frame: In CAR-T cells infusion, up to 52 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05060796.

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 25 Jun 2024.