Solid TumorsNCT07152236
Clinical Study on the Safety and Efficacy of B7H3 CAR T Cells in Patients With B7H3 Positive Solid Tumors
A study testing CAR-T in people with Solid Tumors, run by Guangzhou Bio-gene Technology Co., Ltd at 1 site in China.
Trial summary
This single-arm, single-center investigator-initiated trial (IIT) evaluates the safety, efficacy, and pharmacodynamic (PD)/pharmacokinetic (PK) profiles of CAR-T cells in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 1 year to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2025to 2 Mar 2026
- Phase
- Interventional
- 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 1 year to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient fully understands the study procedures and voluntarily signs the informed consent form.
- Patients diagnosed with tumors that demonstrate positive B7H3 expression in tumor tissues as confirmed by immunohistochemistry (IHC).
- Presence of at least one extracranial lesion that is measurable according to the RECIST 1.1 criteria;
- Estimated survival duration of ≥12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤1 at baseline;
- Recovery from prior treatment-related toxicities to a level below Grade 2.
- Adequate hematopoietic and organ function without severe impairment;
- Availability of suitable venous access for leukapheresis, with no contraindications to the collection of white blood cells.
Who cannot join
- Patients with a history of or currently diagnosed with other malignant tumors;
- Presence of brain metastases or clinically significant central nervous system (CNS) disorders;
- Prior treatment within 14 days or five half-lives (whichever is longer) before blood collection for CAR-T preparation that may interfere with lymphocyte expansion;
- HIV+，HBV，HCV，EBV，CMV.
- Positive T-cell interferon-gamma release assay or sputum smear for tuberculosis;
- Documented history or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or significant pulmonary dysfunction;
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- History of severe allergic reactions or known hypersensitivity to any component of the investigational drugs used in the study;
- Severe cardiovascular disease or uncontrolled refractory hypertension, unless deemed stable and non-interfering with the study by the investigator;
- Severe hepatic or renal dysfunction, or presence of altered mental status;
- Active autoimmune or inflammatory neurological disorders;
- Presence of uncontrolled infections requiring systemic antibiotic, antifungal, or antiviral therapy;
- Receipt of (attenuated) live vaccines within 4 weeks prior to screening;
- Individuals with a history of alcohol dependence or substance abuse;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Evaluating the Safety and Efficacy of B7H3 CAR-T Cell Therapy in Patients With B7H3-Positive Solid Tumors
This single-arm, single-center investigator-initiated trial (IIT) evaluates the safety, efficacy, and pharmacodynamic (PD)/pharmacokinetic (PK) profiles of CAR-T cells in patients with advanced solid tumors.
Eligible subjects are followed until 12 months after infusion or until meeting treatment withdrawal criteria, whichever occurs first.
- Conditions
- Solid Tumors
- Being tested
- CAR-T
- Keywords
- Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-TBiological
Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T | Experimental | The administration can be performed via intravenous infusion, either as a single dose or multiple doses, at a dosage ranging from 3×10⁶ to 1×10⁷ CAR-positive T cells per kilogram of body weight, with an allowable deviation of ±20%. Receives: Biological: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety
Count the Incidence of adverse events
Measured: Up to 1 years after CAR-T infusion
Effectiveness evaluation
According to the RECIST 1.1 evaluation criteria for the efficacy of solid tumors, the objective response rate (ORR) of all patients after CAR-T treatment, including complete response (CR) and partial response (PR).
Measured: Up to 1 year after CAR-T infusion
Secondary outcomes (2)
Pharmacokinetic parameters
The highest concentration of CAR-T cell expansion in peripheral blood after administration
Measured: Up to 1 year after CAR-T infusion
Pharmacodynamic parameters
The peak values of CAR-T-related cytokines, which include at least IL-6 and IFN-γ.
Measured: Up to 1 year after CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start31 Aug 2025
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Why it stopped: Due to corporate strategic adjustment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Bio-gene Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152236
- Sponsor's protocol ID
- CF-25-004
- Status last verified
- May 2026
- First submitted
- 26 Aug 2025
- Last updated
- 28 May 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety and Efficacy of B7H3 CAR-T Cell Therapy in Patients With B7H3-Positive Solid Tumors
- ClinicalTrials.gov ID
- NCT07152236
- Acronym / sponsor ID
- CF-25-004
- Conditions
- Solid Tumors
- Keywords
- Solid Tumors
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to corporate strategic adjustment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangzhou Bio-gene Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 3 Sep 2025 (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 single-arm, single-center investigator-initiated trial (IIT) evaluates the safety, efficacy, and pharmacodynamic (PD)/pharmacokinetic (PK) profiles of CAR-T cells in patients with advanced solid tumors.
Eligible subjects are followed until 12 months after infusion or until meeting treatment withdrawal criteria, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T | Experimental | Biological: CAR-TThe administration can be performed via intravenous infusion, either as a single dose or multiple doses, at a dosage ranging from 3×10⁶ to 1×10⁷ CAR-positive T cells per kilogram of body weight, with an allowable deviation of ±20%. |
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- The patient fully understands the study procedures and voluntarily signs the informed consent form.
- Patients diagnosed with tumors that demonstrate positive B7H3 expression in tumor tissues as confirmed by immunohistochemistry (IHC).
- Presence of at least one extracranial lesion that is measurable according to the RECIST 1.1 criteria;
- Estimated survival duration of ≥12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤1 at baseline;
Key exclusion criteria (14 listed)
- Patients with a history of or currently diagnosed with other malignant tumors;
- Presence of brain metastases or clinically significant central nervous system (CNS) disorders;
- Prior treatment within 14 days or five half-lives (whichever is longer) before blood collection for CAR-T preparation that may interfere with lymphocyte expansion;
- HIV+，HBV，HCV，EBV，CMV.
- Positive T-cell interferon-gamma release assay or sputum smear for tuberculosis;
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-TEligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy. | Biological | CAR-T |
Primary outcome
Evaluation of Safety
Time frame: Up to 1 years after CAR-T infusion
Count the Incidence of adverse events
Effectiveness evaluation
Time frame: Up to 1 year after CAR-T infusion
According to the RECIST 1.1 evaluation criteria for the efficacy of solid tumors, the objective response rate (ORR) of all patients after CAR-T treatment, including complete response (CR) and partial response (PR).
2 secondary outcomes
Pharmacokinetic parameters
Time frame: Up to 1 year after CAR-T infusion
Pharmacodynamic parameters
Time frame: Up to 1 year after CAR-T infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumors
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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR-T in people with Solid Tumors, run by Guangzhou Bio-gene Technology Co., Ltd 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 14 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: withdrawn, as of the sponsor's last update on 28 May 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Safety (time frame: Up to 1 years after CAR-T infusion). 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 28 May 2026.