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Solid TumorsPhase 1NCT07231081

Phase I Study of TX103 CAR-T Cells in Participants With Advanced Solid Tumors

A Phase 1 study testing Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103 in people with Solid Tumors, run by Tcelltech Inc. at 2 sites in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This is a single-arm, open-label, Phase I study to evaluate the safety, tolerability, and antitumor activity of TX103 CAR-T cells in subjects with TX103-positive advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumors
What is being tested?
Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
2 sitesChina
Study dates
16 Oct 2025to 20 Dec 2027
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

  • 1. Voluntary participation: Subjects must voluntarily participate in this clinical trial, fully understand and sign the informed consent form (ICF), and be willing and able to comply with all study procedures.
  • 2. Age: Male or female patients aged ≥18 years and <75 years at the time of signing the ICF.
  • 3. Diagnosis: Subjects must have B7-H3/CD276-positive advanced solid tumors confirmed by pathology, who have failed standard therapy or are intolerant to standard treatment.
  • Intraperitoneal infusion cohort: limited to subjects with recurrent or metastatic ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or other advanced solid tumors with peritoneal metastases confined to the peritoneal cavity.
  • Intravenous infusion cohort: subjects with advanced solid tumors regardless of peritoneal metastasis, preferably including head and neck squamous cell carcinoma, esophageal cancer, lung malignancies, triple-negative breast cancer, colorectal cancer, and mesenchymal-derived malignancies.
  • 4. B7-H3/CD276 expression: Tumor tissue immunohistochemistry (IHC) results show B7-H3/CD276 positivity ≥20%, defined as the percentage of viable tumor cells with positive membrane expression of B7-H3/CD276 in non-necrotic tumor tissue.
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  • 5. Measurable/evaluable disease:
  • Intraperitoneal infusion cohort, Phase Ia: at least one evaluable lesion per RECIST 1.1;
  • Intravenous infusion cohorts (Ia and Ib) and intraperitoneal infusion cohort (Ib): at least one measurable lesion per RECIST 1.1.
  • 6. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • 7. Life expectancy: Expected survival of >6 months. 8. Apheresis capability: Adequate venous access for leukapheresis and no contraindications to the procedure.
  • 9. Adequate organ function (per NCI CTCAE v5.0) within screening period:
  • Hematologic: WBC ≥ 3.0×10⁹/L; hemoglobin ≥ 8.0 g/dL; absolute neutrophil count ≥ 1.5×10⁹/L; platelet count ≥ 75.0×10⁹/L. No transfusions or supportive treatments (e.g., G-CSF, erythropoietin, TPO agonists, IL-11) within 14 days before testing.
  • Renal: Serum creatinine ≤ 1.5× upper limit of normal (ULN) and estimated glomerular filtration rate (eGFR) or creatinine clearance (CrCl, per Cockcroft-Gault formula) > 50 mL/min.
  • Hepatic: ALT and AST ≤ 2.5× ULN (≤ 5.0× ULN for patients with liver metastases).
  • Bilirubin: Total bilirubin ≤ 2.0× ULN (except for patients with Gilbert's syndrome).
  • Coagulation: PT, APTT, or INR ≤ 1.5× ULN (without anticoagulant therapy).
  • Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% within 1 month before enrollment.
  • Pregnancy test: Negative serum pregnancy test for women of childbearing potential.
  • Contraception: Subjects with reproductive potential must agree to use effective contraception from the date of informed consent signing until 365 days after the last infusion.

Who cannot join

  • 1. Pregnant or lactating women. 2. Viral infections:
  • Positive for HIV antibody or syphilis serologic test;
  • Positive for HBsAg or HBcAb with HBV DNA ≥ 2000 IU/mL;
  • Positive for HCV antibody with detectable HCV RNA;
  • Presence of other active viremia. 3. Known hypersensitivity, allergy, intolerance, or contraindication to TX103 CAR-T or any component of the study drugs (including fludarabine, cyclophosphamide, or tocilizumab), or history of severe allergic reactions.
  • 4. Active autoimmune diseases, including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism.
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  • Subjects with vitiligo or childhood asthma that has resolved and requires no intervention may be included.
  • Subjects requiring medical intervention for asthma (e.g., bronchodilators) are excluded.
  • 5. Receiving systemic immunosuppressive therapy, or judged by the investigator to require long-term immunosuppressants during the study. Topical, inhaled, or intranasal corticosteroids are permitted.
  • 6. Prior exposure to any gene-engineered T-cell therapy (including CAR-T or TCR-T) or any other gene therapy.
  • 7. History of organ transplantation. 8. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal metastases.
  • Subjects previously treated for brain/leptomeningeal metastases may be eligible if neurologically stable for ≥1 month (MRI) and off systemic corticosteroids for >2 weeks.
  • 9. Imaging (CT/MRI) showing tumor invasion of major blood vessels (e.g., aorta, pulmonary arteries/veins, vena cava) or indistinct vascular margins.
  • 10. History of epilepsy or seizure-provoking disorders within 1 year prior to infusion.
  • 11. Unresolved toxicities from prior anticancer therapy not recovered to CTCAE v5.0 Grade ≤1, except for investigator-judged non-safety-risk toxicities (e.g., alopecia, Grade 2 peripheral neuropathy, stable hypothyroidism with replacement therapy).
  • 12. Major surgery or significant trauma within 1 month prior to leukapheresis. 13. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase risk or interfere with study results, including but not limited to:
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  • Active infection requiring systemic therapy prior to lymphodepletion;
  • Uncontrolled cardiac disease: unstable angina, myocardial infarction within 1 year, heart failure (NYHA class ≥ II), or clinically significant arrhythmia requiring treatment/intervention;
  • Poorly controlled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg despite therapy);
  • Clinically significant bleeding (e.g., GI bleeding, bleeding ulcers, stool occult blood ++ or above, vasculitis) within 3 months before first infusion;
  • Arterial/venous thrombotic events (e.g., stroke, TIA, intracerebral hemorrhage, DVT, pulmonary embolism) within 6 months before first infusion;
  • Clinically significant pleural, pericardial, or peritoneal effusions not controllable by drainage or other means;
  • Severe cirrhosis, hepatic atrophy, or severe portal hypertension;
  • Complete intestinal obstruction. 14. History of or concurrent malignancy within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, or breast).

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Cancer Hospital

    Beijing

  • Beijing Gaobo Hospital

    Beijing

Other trials in China

About this study

Official title: An Open-label, Single-arm, Phase I Clinical Trial to Evaluate the Safety and Efficacy of TX103 CAR-T Cells in Participants With Advanced Solid Tumors

This is a single-arm, open-label, Phase I study to evaluate the safety, tolerability, and antitumor activity of TX103 CAR-T cells in subjects with TX103-positive advanced solid tumors. The study also aims to explore the maximum tolerated dose (MTD) and determine the recommended Phase II dose (RP2D) of TX103 CAR-T cell therapy.

Conditions
Solid Tumors
Being tested
Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103

What participants receive

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

  • Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103Biological

    TX103 CAR-T cells are autologous T cells genetically engineered to express a chimeric antigen receptor (CAR) targeting TX103-positive tumor cells. This therapy is designed to recognize and kill TX103-expressing malignant cells.

    TX103 CAR-T cells are administered either via intravenous (IV) infusion or intraperitoneal (IP) infusion, depending on the cohort. For dose-escalation cohorts (Phase Ia), a standard 3+3 design is used:

    1. IV dose-escalation cohort: planned doses range from 1.0 × 10⁸ to 2.0 × 10⁹ CAR-T cells.
    2. IP dose-escalation cohort: initiated sequentially after the IV cohort; starting dose is based on the safe and potentially efficacious dose from IV cohort, with planned escalation up to 4.0 × 10⁹ CAR-T cells.

    The Phase Ib expansion cohort administers TX103 CAR-T at the dose determined to be safe and potentially efficacious in Phase Ia, focusing on tumor types that showed preliminary signs of antitumor activity and meet clinical needs.

    TX103 CAR-T therapy is distinct fro

Study groups in NCT07231081
Study groupRoleWhat they receive
IV Dose-Escalation CohortExperimentalSubjects in this arm will receive TX103 CAR-T cells via intravenous infusion. A standard 3+3 dose-escalation design will be used to evaluate safety, tolerability, and preliminary antitumor activity. The planned dose levels are as follows:Dose Level 1: 1.0 × 10⁸ CAR-T cells;Dose Level 2: 3.0 × 10⁸ CAR-T cells;Dose Level 3: 9.0 × 10⁸ CAR-T cells;Dose Level 4: 2.0 × 10⁹ CAR-T cells.
Receives: Biological: Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103
IP Dose-Escalation CohortExperimentalSubjects in this arm will receive TX103 CAR-T cells via intraperitoneal (IP) infusion. This cohort will be initiated sequentially after the IV dose-escalation cohort. The starting dose for the IP cohort will be based on the safe and potentially efficacious dose identified in the IV cohort. Further dose escalation will be determined by the Safety Science Committee based on accumulated safety and efficacy data. The planned dose levels are as follows:Dose Level 1: 1.0 × 10⁸ CAR-T cells;Dose Level 2: 3.0 × 10⁸ CAR-T cells;Dose Level 3: 9.0 × 10⁸ CAR-T cells;Dose Level 4: 2.0 × 10⁹ CAR-T cells;Dose Level 5: 4.0 × 10⁹ CAR-T cells. Dose escalation will proceed sequentially, with safety evaluation at each dose level before escalation.
Receives: Biological: Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103
Expansion Cohort (Phase Ib)ExperimentalSubjects in this arm will receive TX103 CAR-T cells at the dose determined to be safe and potentially efficacious in the Phase Ia dose-escalation cohorts. The expansion cohort will focus on tumor types that showed preliminary signs of antitumor activity in Phase Ia, and selection will also consider clinical needs and other relevant factors. The purpose of this cohort is to further evaluate the safety, tolerability, and preliminary efficacy of TX103 CAR-T therapy in these selected tumor types.
Receives: Biological: Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103

What is being measured

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

  1. Safety#Incidence and severity of adverse events (AEs)

    To evaluate the possible adverse events after TX103 infusion, including the incidence, and severity of AEs.

    Measured: 1 year post CAR-T cells infusion

  2. Safety#Incidence of Dose Limiting Toxicity (DLT)

    Type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TX103 infusion.

    Measured: 28 days after the first TX103 infusion

  3. The maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of TX103

    Measured: From first dose of TX103 until the end of Dose Limiting Toxicity (DLT) observation period (typically 28 days post-infusion for each dose).

Secondary outcomes (7)

  1. Progression Free Survival (PFS)

    To evaluate the time from the start of TX103 therapy to disease progression (according to RICIST1.1 criteria) or death from any cause, whichever occurs first.

    Measured: 1 year post CAR-T cells infusion

  2. Disease Control Rate (DCR)

    To evaluate the proportion of subjects who achieved CR/PR/SD in the best overall response according to RICIST1.1 criteria.

    Measured: 1 year post CAR-T cells infusion.

  3. Overall survival (OS)

    The proportion of subjects who have survived for more than 6 and 12 months since the first infusion.

    Measured: 6 and 12 months post CAR-T cells infusion

  4. Objective response rate (ORR)

    To evaluate the proportion of subjects who achieved CR/PR in the best response condition according to RICIST1.1 criteria.

    Measured: 1 year post CAR-T cells infusion

  5. Time to Remission (TTR)

    To evaluate the time from the start of treatment to the first remission (CR/PR).

    Measured: 1 year post CAR-T cells infusion.

  6. Duration of Response (DOR)

    Defined as the time from the first evaluation of the tumor as CR or PR to the first evaluation of PD or death from any cause.

    Measured: 1 year post CAR-T cells infusion.

  7. Duration of disease control (DDC)

    To evaluate the time from the first evaluation of tumor as CR, PR or SD to the first evaluation of PD or death from any cause.

    Measured: 1 year post CAR-T cells infusion.

Timeline

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

  1. First posted17 Nov 2025
  2. Study start16 Oct 2025
  3. Primary completion20 Dec 2027 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Why it stopped: Following a comprehensive review and strategic realignment of the company's operations and projects in 2026, the Sponsor made the decision to voluntarily suspend the clinical trial.

Resources

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
Single group
Masking
None (open label)
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07231081
Sponsor's protocol ID
TX103T-RP007
Status last verified
Nov 2025
First submitted
13 Nov 2025
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103 in people with Solid Tumors, run by Tcelltech Inc. at 2 sites 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 20 inclusion and 25 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: paused, as of the sponsor's last update on 14 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 2 sites 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?

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?

Safety#Incidence and severity of adverse events (AEs) (time frame: 1 year post CAR-T cells infusion). The study lists 3 primary outcomes in all. 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 NCT07231081.

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 14 Oct 2026.

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