EGFR/ B7H3-positive Advanced Lung CancerEarly Phase 1NCT05341492
EGFR/B7H3 CAR-T on Lung Cancer and Triple Negative Breast Cancer
A Early Phase 1 study testing EGFR/B7H3 CAR-T in people with EGFR/ B7H3-positive Advanced Lung Cancer and EGFR/ B7H3-positive Advanced Triple-negative Breast Cancer, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study is a single-arm, open, exploratory clinical study to evaluate the safety and efficacy of EGFR/B7H3 CAR-T in patients with EGFR/ B7H3-positive advanced solid tumors (lung cancer and triple-negative breast cancer) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- EGFR/ B7H3-positive Advanced Lung Cancer, EGFR/ B7H3-positive Advanced Triple-negative Breast Cancer
- What is being tested?
- EGFR/B7H3 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 May 2035
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.All subjects or legal guardians must sign the informed consent form approved by the ethics committee in writing before starting any screening procedure;
- 2.18 Years to 75 Years, Histologically or cytologically confirmed Routine treatment of patients with advanced lung cancer and triple-negative breast cancer(Including TKI treatment failure patients);
- 3.EGFR/B7H3 expression was confirmed positive in tumor site by immunohistochemical test within 3 months before signing the informed consent form;
- 4.According to RECIST version 1.1 of solid tumor efficacy evaluation criteria, there should be at least one measurable lesion during screening period (results are available within one month prior to screening period) ;
- 5.Expected survival time ≥ 12 weeks;
- 6.The Eastern oncology group strength status score (ECOG) was 0-1;
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- 7.Adequate organ function: alanine aminotransferase, aspartate aminotransferase (ALT, AST) < 3 times of normal value, total bilirubin (TBiL) < 1.5 times of normal value, serum creatinine (SCr) < 1.5 times of normal value;
- 8.The hemodynamics determined by echocardiography or multichannel radionuclide angiography(MUGA) are stable and the left ventricular ejection fraction (LVEF)≥50%;
- 9.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 1 × 10^9/L;Platelet≥100 x 10^9/L; Hemoglobin ≥100 g/L;
- 10.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
- 1.Uncontrolled hypertension (> 160/95), unstable coronary artery disease confirmed by uncontrolled arrhythmia, unstable angina pectoris, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months prior to cell infusion;
- 2.Patients with severe liver and kidney dysfunction or consciousness disorder;
- 3.Patients who received antitumor chemotherapy other than lymphocyte clearance chemotherapy within 14 days prior to CAR T infusion;
- 4.Patients who received other study drugs within 14 days prior to infusion;
- 5. Patients treated with radiotherapy or TKI within 2 weeks prior to infusion;
- 6. Patients with active hepatitis B: HBV DNA>1000IU/mL;
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- 7. HIV antibody, hepatitis C antibody, treponema pallidum antibody positive patients;
- 8. Sputum smears and patients who test positive for T cells of tuberculosis infection
- 9.Patients with interstitial lung disease or pneumonia;
- 10.patients with uncontrolled acute life-threatening bacterial, viral or fungal infection (e.g. positive blood culture ≤72 hours prior to infusion);
- 11.Patients with central nervous primary tumor or central metastasis solid tumor (patients with stable treatment for more than 4 weeks after brain metastasis or patients with asymptomatic brain metastasis without treatment are excluded from this range), and patients with pericardial metastasis accompanied by large pericardial effusion.
- 12.Patients with a prior or concurrent second tumor, except in the following cases:
- Adequately treated basal cell or squamous cell carcinoma (adequate wound healing required prior to enrollment);
- Carcinoma in situ of cervical or breast cancer with no signs of recurrence for at least 3 years prior to study after curative treatment;
- The primary malignancy has been completely resected and in complete remission for ≥5 years.
- 13.Pregnant or lactating women;
- 14.Patients who have a history of or currently have T-cell tumors;
- 15. have active neuroautoimmune or inflammatory disorders (e.g. Guillian-Barre syndrome, AMyotrophic lateral sclerosis);
- 16.Other conditions, such as compliance, that the investigator considers should not be included 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.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Zhang Zhenfeng, MD, PhD, +862039195966, zhangzhf@gzhmu.edu.cn
About this study
Official title: A Single-arm, Open, Exploratory Clinical Study Evaluating the Safety and Efficacy of EGFR/B7H3 CAR-T in Patients With EGFR/ B7H3-positive Advanced Solid Tumors (Lung and Triple-negative Breast Cancer)
This study is a single-arm, open, exploratory clinical study to evaluate the safety and efficacy of EGFR/B7H3 CAR-T in patients with EGFR/ B7H3-positive advanced solid tumors (lung cancer and triple-negative breast cancer)
- Conditions
- EGFR/ B7H3-positive Advanced Lung Cancer, EGFR/ B7H3-positive Advanced Triple-negative Breast Cancer
- Being tested
- EGFR/B7H3 CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR/B7H3 CAR-TBiological
2 × 10^6/kg CAR-T cells,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 |
|---|---|---|
| Treatment | Experimental | Patients will receive 2*10e6/kgCAR-T cells. Receives: Biological: EGFR/B7H3 CAR-T |
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/B7H3 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.
- First posted22 Apr 2022
- Study start1 May 2022
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EGFR/ B7H3-positive Advanced 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luo min, PhD, Study chair, Guangzhou Bio-gene Technology Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341492
- Sponsor's protocol ID
- ZZBGCART-016
- Status last verified
- Jun 2024
- First submitted
- 18 Apr 2022
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ou Y, Zhang J, Tan H, He B, Li T, Liu M, Zhi C, Huang J, Li M, Zuo S, Shah NUH, Chen Y, Huang J, Chen D, Qin R, Li X, Lian H, Wu Q, Yang H, Zhang Z. CT-guided intratumoral immunotherapy for advanced solid tumors: a prospective clinical study of safety and systemic antitumor effects. Front Immunol. 2026 Jul 24;17:1869154. doi: 10.3389/fimmu.2026.1869154. eCollection 2026.
PubMed 42568612
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, Exploratory Clinical Study Evaluating the Safety and Efficacy of EGFR/B7H3 CAR-T in Patients With EGFR/ B7H3-positive Advanced Solid Tumors (Lung and Triple-negative Breast Cancer)
- ClinicalTrials.gov ID
- NCT05341492
- Acronym / sponsor ID
- ZZBGCART-016
- Conditions
- EGFR/ B7H3-positive Advanced Lung Cancer, EGFR/ B7H3-positive Advanced Triple-negative Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2035 (estimated)
- First posted
- 22 Apr 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.
This study is a single-arm, open, exploratory clinical study to evaluate the safety and efficacy of EGFR/B7H3 CAR-T in patients with EGFR/ B7H3-positive advanced solid tumors (lung cancer and triple-negative breast cancer)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: EGFR/B7H3 CAR-TPatients will receive 2*10e6/kgCAR-T cells. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1.All subjects or legal guardians must sign the informed consent form approved by the ethics committee in writing before starting any screening procedure;
- 2.18 Years to 75 Years, Histologically or cytologically confirmed Routine treatment of patients with advanced lung cancer and triple-negative breast cancer(Including TKI treatment failure patients);
- 3.EGFR/B7H3 expression was confirmed positive in tumor site by immunohistochemical test within 3 months before signing the informed consent form;
- 4.According to RECIST version 1.1 of solid tumor efficacy evaluation criteria, there should be at least one measurable lesion during screening period (results are available within one month prior to screening period) ;
- 5.Expected survival time ≥ 12 weeks;
Key exclusion criteria (19 listed)
- 1.Uncontrolled hypertension (> 160/95), unstable coronary artery disease confirmed by uncontrolled arrhythmia, unstable angina pectoris, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months prior to cell infusion;
- 2.Patients with severe liver and kidney dysfunction or consciousness disorder;
- 3.Patients who received antitumor chemotherapy other than lymphocyte clearance chemotherapy within 14 days prior to CAR T infusion;
- 4.Patients who received other study drugs within 14 days prior to infusion;
- 5. Patients treated with radiotherapy or TKI within 2 weeks prior to 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 |
|---|---|---|
| EGFR/B7H3 CAR-T2 × 10^6/kg CAR-T cells,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 | Treatment |
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/B7H3 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.
- Derived from this study: PubMed 42568612Ou Y, Zhang J, Tan H, He B, Li T, Liu M, Zhi C, Huang J, Li M, Zuo S, Shah NUH, Chen Y, Huang J, Chen D, Qin R, Li X, Lian H, Wu Q, Yang H, Zhang Z. CT-guided intratumoral immunotherapy for advanced solid tumors: a prospective clinical study of safety and systemic antitumor effects. Front Immunol. 2026 Jul 24;17:1869154. doi: 10.3389/fimmu.2026.1869154. eCollection 2026.
- Individual participant dataSharing planned: No
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.
Luo min, PhD study chair
Guangzhou Bio-gene Technology Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EGFR/B7H3 CAR-T in people with EGFR/ B7H3-positive Advanced Lung Cancer and EGFR/ B7H3-positive Advanced Triple-negative Breast Cancer, run by Second Affiliated Hospital of Guangzhou Medical 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 10 inclusion and 19 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 Zhang Zhenfeng, PhD (+862039195965, 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 NCT05341492, which also lists 1 linked publication.
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.