Non Small Cell Lung CancerPhase 1NCT04153799
Study of CXCR5 Modified EGFE Chimeric Antigen Receptor Autologous T Cells in EGFR- Positive Patients With Advanced Non-small Cell Lung Cancer
A Phase 1 study testing CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells in people with Non Small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is a clinical study on the safety, efficacy and I phase of single center, single arm, open-dose climbing, 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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 Nov 2019to Dec 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- 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;
- 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 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;
- Patients undergoing radiotherapy 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.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yuxiang Ma, M.D., 86-020-87343894, mayx@sysucc.org.cn
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
This study is a clinical study on the safety, efficacy and I phase of single center, single arm, open-dose climbing, 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 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
- Keywords
- EGFR, CAR-T cells, NSCLC
- 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 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.
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.
Secondary outcomes (3)
Peak Plasma Concentration (Cmax) of CAR T cells in patients.
Cmax of CAR T cells in patients is monitored by flow or qPCR.
Measured: In CAR-T cells infusion, up to 6 weeks.
Peak plasma time (Tmax) of CAR T cells in patients.
Tmax of CAR T cells in patients is monitored by flow or qPCR.
Measured: In CAR-T cells infusion, up to 6 weeks.
Area under the plasma concentration versus time curve (AUC) of CAR T cells in patients.
AUC of CAR T cells in patients is monitored by flow or qPCR.
Measured: In CAR-T cells infusion, up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Nov 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (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 Sun Yat-sen 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Bio-gene Technology Co., Ltd
- Responsible party
- Principal investigator, Li Zhang, MD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153799
- Sponsor's protocol ID
- B2019-136-01
- Status last verified
- May 2020
- First submitted
- 9 Oct 2019
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. 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
- NCT04153799
- Acronym / sponsor ID
- B2019-136-01
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- EGFR, CAR-T cells, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Bio-gene Technology Co., Ltd
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Nov 2019 (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.
This study is a clinical study on the safety, efficacy and I phase of single center, single arm, open-dose climbing, 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).
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.
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
- Not 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;
- 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 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;
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.
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.
3 secondary outcomes
Peak Plasma Concentration (Cmax) of CAR T cells in patients.
Time frame: In CAR-T cells infusion, up to 6 weeks.
Peak plasma time (Tmax) of CAR T cells in patients.
Time frame: In CAR-T cells infusion, up to 6 weeks.
Area under the plasma concentration versus time curve (AUC) of CAR T cells in patients.
Time frame: In CAR-T cells infusion, up to 6 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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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.
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 CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells in people with Non Small Cell Lung Cancer, run by Sun Yat-sen 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 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: status not confirmed, as of the sponsor's last update on 12 May 2020. 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 Yuxiang Ma, M.D. (86 020 87343894, mayx@sysucc.org.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.). The study lists 2 primary outcomes in all. 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 12 May 2020.