Advanced Solid TumorPhase 1NCT07859462
Phase I Study of In Vivo CAR-Tumor Technology for the Treatment of Advanced Malignant Tumors
A Phase 1 study testing CAR-Tumor05, CAR-Tumor 05 and CAR-Tumor M01 in people with Advanced Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a single-arm, open-label, dose-escalation platform clinical trial designed to evaluate the safety, tolerability, efficacy, pharmacokinetic and pharmacodynamic characteristics of CAR-Tumour oncolytic virus as a vector platform for the treatment of advanced malignant tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CAR-Tumor05, CAR-Tumor 05 and CAR-Tumor M01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 30 Jul 2027
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form, understand the study, agree to comply with the protocol, and agree to complete all trial procedures;
- Be aged 18 years or over at the time of signing the informed consent form; gender is not restricted.
- Patients with advanced solid tumours confirmed by histological and/or cytological examination of the primary and/or metastatic lesions.
- Patients who have failed standard treatment, are at the end of standard treatment options, or are unsuitable for standard treatment for medical reasons.
- Participants with an ECOG performance status score of 0-2 and an expected survival of at least 12 weeks.
- Adequate organ and haematopoietic function: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count ≥ 75 × 10⁹/L (no platelet transfusions or thrombopoietin (TPO) therapy within 2 weeks prior to the first dose); haemoglobin ≥ 90 g/L (no blood transfusions within 2 weeks); Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or endogenous creatinine clearance (CCr) ≥ 50 mL/min; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN; in patients with liver metastases, AST and ALT < 5 × ULN; total serum bilirubin (TBIL) ≤ 2 × ULN; International Normalised Ratio (INR) ≤ 1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
- Women of childbearing potential must undergo a pregnancy test within 7 days prior to the start of treatment, with a negative result.
- Male and female subjects of childbearing potential must agree to use reliable contraception during the trial and for at least 6 months following the last dose.
Who cannot join
- Subjects who have had other active malignant tumours within the past 5 years. Excluded are subjects who have been completely cured and do not require follow-up treatment, and subjects whose malignant tumours fall within the scope of the indication;
- The longest diameter of the lesion to be injected is >100 mm;
- Subjects who have participated in or are currently participating in clinical trials of other drugs or medical devices within the past 4 weeks;
- Subjects who are scheduled to undergo or have previously undergone a tissue/organ transplant;
- Subjects with human immunodeficiency virus (HIV) infection who have had AIDS-related opportunistic infections within the past 12 months, or whose CD4+ T-cell (CD4+) count is < 350 cells/μL; Patients who are positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) during the screening period, and whose HBV-DNA is above the lower limit of detection; patients who are positive for HCV antibody during the screening period and whose HCV-RNA is above the lower limit of detection; subjects with a positive serological reaction for Treponema pallidum;
- Subjects who require antiviral medication during the study period or who are within 5 half-lives of antiviral medication at the time of the first dose.
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- Subjects who require therapeutic anticoagulants during the study period.
- Subjects with uncontrolled active infections of grade ≥3 according to CTCAE V6.0 that are clinically significant;
- Recipients who have received anticancer drug therapy, including chemotherapy, radiotherapy, biological therapy, endocrine therapy or immunotherapy, within 4 weeks prior to the first dose; recipients who have received small-molecule targeted therapy or oral fluoropyrimidine agents within 2 weeks prior to the first dose or within 5 half-lives (whichever is longer); Received traditional Chinese herbal medicines or proprietary Chinese medicines with anti-tumour indications within 2 weeks prior to the first dose; received nitrosoureas or mitomycin C within 6 weeks prior to the first dose; palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to the first dose);
- Hypertension or pulmonary arterial hypertension uncontrolled by medication, or unstable angina; myocardial infarction or bypass or stent surgery within 6 months prior to dosing; history of chronic heart failure classified as New York Heart Association (NYHA) Class 3-4; Severe arrhythmias requiring treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia deemed by the investigator to have no impact on the trial), including QTcF ≥450 ms in males and ≥470 ms in females (calculated using the Fridericia formula); cerebrovascular accident (CVA) or transient ischaemic attack (TIA) within 6 months prior to enrolment;
- Patients with active autoimmune diseases or a history of autoimmune diseases that may recur; however, patients with the following conditions are not excluded and may be further screened: type 1 diabetes; hypothyroidism (if controlled by hormone replacement therapy alone); well-controlled coeliac disease; skin conditions not requiring systemic treatment (e.g. vitiligo, psoriasis, alopecia); any other condition that will not recur in the absence of external triggers;
- Subjects who require systemic corticosteroids (>10 mg/day prednisolone or equivalent dose) or other immunosuppressive agents within 14 days prior to the first dose or during the study, with the following exceptions: adrenal replacement steroids (prednisolone ≤10 mg/day or equivalent dose of a similar agent); Topical, ophthalmic, intra-articular, intranasal or inhaled corticosteroids; prophylactic short-term (≤7 days) use of corticosteroids (e.g., for contrast medium allergy) or for the treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by contact allergens);
- Subjects who are scheduled to receive any live vaccine during the screening or treatment periods;
- Subjects with hypersensitivity to any component of the study drug, immunotherapy or related medications;
- Subjects with psychiatric disorders, alcoholism, inability to quit smoking, drug addiction or substance abuse;
- Pregnant or breastfeeding women;
- Adverse reactions from previous anticancer treatment have not yet resolved to Grade 1 (CTCAE 5.0) (excluding alopecia);
- The investigator determines that the subject has a serious uncontrolled medical condition, or other circumstances that may affect their ability to receive treatment in this study, and deems them unsuitable for participation;
- Other circumstances deemed by the investigator to render the subject unsuitable for enrolment.
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
Cancer Hospital Chinese Academy of Medical Sciences 17 Panjiayuan Nanli, Chaoyang District
Beijing, Beijing Municipality, 100021
About this study
Official title: A Phase I Platform Study on the Treatment of Advanced Malignant Tumors Using In Vivo CAR-Tumor Technology
This study is a single-arm, open-label, dose-escalation platform clinical trial designed to evaluate the safety, tolerability, efficacy, pharmacokinetic and pharmacodynamic characteristics of CAR-Tumour oncolytic virus as a vector platform for the treatment of advanced malignant tumours.
Subjects will be screened and assigned to cohorts based on target and indication:
Cohort A: Intratumoural injection or intravenous injection of CAR-Tumor05 solution for the treatment of advanced malignant solid tumours Co-group B: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, and intraperitoneal perfusion of CAR-Tumor05 injection for the treatment of advanced malignant solid tumours Co-group C: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, and intraperitoneal perfusion of CAR-Tumor M01 injection for the treatment of advanced malignant solid tumours
Read the detailed description
This study is a single-arm, open-label, dose-escalation platform clinical trial designed to evaluate the safety, tolerability, efficacy, pharmacokinetic and pharmacodynamic characteristics of CAR-Tumour oncolytic virus as a vector platform for the treatment of advanced malignant tumours.
Dose escalation and subject enrolment principles
Dose Escalation Protocol:
This study employs a 3+3 design to identify the Maximum Tolerated Dose (MTD), and based on the MTD determination, the Recommended Phase 2 Dose (RP2D) will be established. A total of two dose groups are established.
In the initial Dose Group 1, following the first administration to the first subject, a 21-day DLT observation period will commence. If no DLT occurs during this period, the next two subjects at this dose level will be enrolled and receive their first administration, followed by a similar 21-day DLT observation period.
From dose level 2 onwards, there will also be a 21-day interval between the enrolment of the first and second subjects, who will then receive treatment at the corresponding dose level. Following the first administration, subjects will enter a 21-day DLT observation period; if no DLT occurs, further subjects at this dose level will be enrolled.
Subjects will be screened and assigned to cohorts based on target and indication:
Cohort A: Intratumoural injection or intravenous injection of CAR-Tumor05 solution for the treatment of advanced malignant solid tumours Co-group B: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, and intraperitoneal perfusion of CAR-Tumor05 injection for the treatment of advanced malignant solid tumours Co-group C: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, and intraperitoneal perfusion of CAR-Tumor M01 injection for the treatment of advanced malignant solid tumours
- Conditions
- Advanced Solid Tumor
- Being tested
- CAR-Tumor05, CAR-Tumor 05, CAR-Tumor M01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-Tumor05Biological
Intralesional injection, intravenous injection
CAR-Tumor 05Biological
Intralesional injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, intraperitoneal perfusion
CAR-Tumor M01Biological
Intralesional injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, intraperitoneal perfusion
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Intratumoural and intravenous administration of CAR-Tumor05 for the treatment of advanced malignant solid tumours，Two dose groups were established: 6 × 10⁹ PFU/mL and 6 × 10¹⁰ PFU/mL. Administration took place on day 1 (D1) of each cycle, with each treatment cycle lasting two weeks; a maximum of six cycles were administered, with multiple doses administered on the same day. Receives: Biological: CAR-Tumor05 |
| Group B | Experimental | Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion and intraperitoneal perfusion of CAR-Tumor05 injection for the treatment of advanced malignant solid tumours，Two dose groups were established: 6 × 10⁹ PFU/mL and 6 × 10¹⁰ PFU/mL. Administration took place on day 1 (D1) of each cycle, with each treatment cycle lasting two weeks; a maximum of six cycles were administered, with multiple doses administered on the same day. Receives: Biological: CAR-Tumor 05 |
| Group C | Experimental | Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion and intraperitoneal perfusion of CAR-Tumor M01 injection for the treatment of advanced malignant solid tumours，Two dose groups were established: 6 × 10⁶ PFU/mL and 6 × 10¹¹ PFU/mL. Administration took place on day 1 (D1) of each cycle, with each treatment cycle lasting two weeks; a maximum of six cycles were administered, with multiple administration routes administered on the same day. Receives: Biological: CAR-Tumor M01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
In accordance with the internationally recognised CTCAE V6.0 toxicity assessment criteria
Measured: the study drug OVV-01 occurring within 3 weeks of the first dose.
Secondary outcomes (5)
Incidence of Adverse Events (AEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.
Measured: From signing ICF until 24 months after the last infusion
ORR
The proportion of subjects achieving CR or PR will be assessed according to RECIST 1.1.
Measured: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
DCR
The proportion of subjects achieving CR, PR, or SD will be assessed according to RECIST 1.1.
Measured: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months
PFS
The time from the first study treatment to the first documented disease progression or death from any cause (whichever occurs first) will be assessed according to RECIST 1.1.
Measured: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
OS
The time from the first study treatment to death from any cause will be assessed according to RECIST 1.1.
Measured: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Co-group A: Treatment of advanced malignant solid tumours with intratumoural and intravenous administration of CAR-Tumor05 injection Co-group B: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion and intraperitoneal perfusion of CAR-Tumor05 Injection for the treatment of advanced malignant solid tumours Co-group C: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion and intraperitoneal perfusion of CAR-Tumor M01 Injection for the treatment of advanced malignant solid tumours \*\*\* Translated with www.DeepL.com/Translator (free version) \*\*\*
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Joint Biosciences Ltd.
- Responsible party
- Principal investigator, NING LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Ning Li, Principal investigator, The Cancer Hospital of the Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859462
- Sponsor's protocol ID
- CAR-Tumor-A01
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Platform Study on the Treatment of Advanced Malignant Tumors Using In Vivo CAR-Tumor Technology
- ClinicalTrials.gov ID
- NCT07859462
- Acronym / sponsor ID
- CAR-Tumor-A01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Joint Biosciences Ltd.
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 5 Oct 2026 (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-label, dose-escalation platform clinical trial designed to evaluate the safety, tolerability, efficacy, pharmacokinetic and pharmacodynamic characteristics of CAR-Tumour oncolytic virus as a vector platform for the treatment of advanced malignant tumours.
Subjects will be screened and assigned to cohorts based on target and indication:
Cohort A: Intratumoural injection or intravenous injection of CAR-Tumor05 solution for the treatment of advanced malignant solid tumours Co-group B: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, and intraperitoneal perfusion of CAR-Tumor05 injection for the treatment of advanced malignant solid tumours Co-group C: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, and intraperitoneal perfusion of CAR-Tumor M01 injection for the treatment of advanced malignant solid tumours
Detailed description
This study is a single-arm, open-label, dose-escalation platform clinical trial designed to evaluate the safety, tolerability, efficacy, pharmacokinetic and pharmacodynamic characteristics of CAR-Tumour oncolytic virus as a vector platform for the treatment of advanced malignant tumours.
Dose escalation and subject enrolment principles
Dose Escalation Protocol:
This study employs a 3+3 design to identify the Maximum Tolerated Dose (MTD), and based on the MTD determination, the Recommended Phase 2 Dose (RP2D) will be established. A total of two dose groups are established.
In the initial Dose Group 1, following the first administration to the first subject, a 21-day DLT observation period will commence. If no DLT occurs during this period, the next two subjects at this dose level will be enrolled and receive their first administration, followed by a similar 21-day DLT observation period.
From dose level 2 onwards, there will also be a 21-day interval between the enrolment of the first and second subjects, who will then receive treatment at the corresponding dose level. Following the first administration, subjects will enter a 21-day DLT observation period; if no DLT occurs, further subjects at this dose level will be enrolled.
Subjects will be screened and assigned to cohorts based on target and indication:
Cohort A: Intratumoural injection or intravenous injection of CAR-Tumor05 solution for the treatment of advanced malignant solid tumours Co-group B: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, and intraperitoneal perfusion of CAR-Tumor05 injection for the treatment of advanced malignant solid tumours Co-group C: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, and intraperitoneal perfusion of CAR-Tumor M01 injection for the treatment of advanced malignant solid tumours
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Co-group A: Treatment of advanced malignant solid tumours with intratumoural and intravenous administration of CAR-Tumor05 injection Co-group B: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion and intraperitoneal perfusion of CAR-Tumor05 Injection for the treatment of advanced malignant solid tumours Co-group C: Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion and intraperitoneal perfusion of CAR-Tumor M01 Injection for the treatment of advanced malignant solid tumours * Translated with www.DeepL.com/Translator (free version) *
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: CAR-Tumor05Intratumoural and intravenous administration of CAR-Tumor05 for the treatment of advanced malignant solid tumours，Two dose groups were established: 6 × 10⁹ PFU/mL and 6 × 10¹⁰ PFU/mL. Administration took place on day 1 (D1) of each cycle, with each treatment cycle lasting two weeks; a maximum of six cycles were administered, with multiple doses administered on the same day. |
| Group B | Experimental | Biological: CAR-Tumor 05Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion and intraperitoneal perfusion of CAR-Tumor05 injection for the treatment of advanced malignant solid tumours，Two dose groups were established: 6 × 10⁹ PFU/mL and 6 × 10¹⁰ PFU/mL. Administration took place on day 1 (D1) of each cycle, with each treatment cycle lasting two weeks; a maximum of six cycles were administered, with multiple doses administered on the same day. |
| Group C | Experimental | Biological: CAR-Tumor M01Intratumoural injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion and intraperitoneal perfusion of CAR-Tumor M01 injection for the treatment of advanced malignant solid tumours，Two dose groups were established: 6 × 10⁶ PFU/mL and 6 × 10¹¹ PFU/mL. Administration took place on day 1 (D1) of each cycle, with each treatment cycle lasting two weeks; a maximum of six cycles were administered, with multiple administration routes administered on the same day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily sign the informed consent form, understand the study, agree to comply with the protocol, and agree to complete all trial procedures;
- Be aged 18 years or over at the time of signing the informed consent form; gender is not restricted.
- Patients with advanced solid tumours confirmed by histological and/or cytological examination of the primary and/or metastatic lesions.
- Patients who have failed standard treatment, are at the end of standard treatment options, or are unsuitable for standard treatment for medical reasons.
- Participants with an ECOG performance status score of 0-2 and an expected survival of at least 12 weeks.
Key exclusion criteria (19 listed)
- Subjects who have had other active malignant tumours within the past 5 years. Excluded are subjects who have been completely cured and do not require follow-up treatment, and subjects whose malignant tumours fall within the scope of the indication;
- The longest diameter of the lesion to be injected is >100 mm;
- Subjects who have participated in or are currently participating in clinical trials of other drugs or medical devices within the past 4 weeks;
- Subjects who are scheduled to undergo or have previously undergone a tissue/organ transplant;
- Subjects with human immunodeficiency virus (HIV) infection who have had AIDS-related opportunistic infections within the past 12 months, or whose CD4+ T-cell (CD4+) count is < 350 cells/μL; Patients who are positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) during the screening period, and whose HBV-DNA is above the lower limit of detection; patients who are positive for HCV antibody during the screening period and whose HCV-RNA is above the lower limit of detection; subjects with a positive serological reaction for Treponema pallidum;
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 |
|---|---|---|
| CAR-Tumor05Intralesional injection, intravenous injection | Biological | Group A |
| CAR-Tumor 05Intralesional injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, intraperitoneal perfusion | Biological | Group B |
| CAR-Tumor M01Intralesional injection, intravenous injection, subcutaneous injection, intramuscular injection, pleural perfusion, intraperitoneal perfusion | Biological | Group C |
Primary outcome
DLT
Time frame: the study drug OVV-01 occurring within 3 weeks of the first dose.
In accordance with the internationally recognised CTCAE V6.0 toxicity assessment criteria
5 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: From signing ICF until 24 months after the last infusion
ORR
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
DCR
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months
PFS
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
OS
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
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 5 Oct 2026.
- 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.
Ning Li principal investigator
The Cancer Hospital of the Chinese Academy of Medical Sciences
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 CAR-Tumor05, CAR-Tumor 05 and CAR-Tumor M01 in people with Advanced Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 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: opening soon, as of the sponsor's last update on 5 Oct 2026. 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?
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 Yanjie Han (01087788165, annyhan_1997@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: the study drug OVV-01 occurring within 3 weeks of the first dose.). 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 5 Oct 2026.