Solid CancerEarly Phase 1NCT07242417
TC-G203 for Patients With GPC3-Positive Advanced Solid Tumors
A Early Phase 1 study testing TC-G203 cells treatment in people with Solid Cancer and GPC3 Positive Hepatocellular Carcinoma, run by Beijing GoBroad Hospital at 2 sites in China.
Trial summary
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-G203 in patients with GPC3-positive recurrent or metastatic solid tumors who have progressed after prior therapies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Cancer, GPC3 Positive Hepatocellular Carcinoma
- What is being tested?
- TC-G203 cells treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 18 Dec 2025to 1 Nov 2027
- 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
- Participants must voluntarily provide written informed consent.
- Aged 18-75 years (inclusive).
- Life expectancy ≥ 12 weeks.
- ECOG performance status 0-1.
- Failed or unsuitable for standard therapy.
- At least one measurable lesion per RECIST 1.1.
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- GPC3-positive tumor confirmed by immunohistochemistry.
- Adequate organ and bone marrow function.
- Effective contraception required for participants of childbearing potential.
- Adequate venous access for leukapheresis.
Who cannot join
- Primary CNS malignancy or uncontrolled CNS metastases.
- Other malignancies within 5 years
- Active autoimmune disease or history of autoimmune disease.
- Immunodeficiency, including HIV positivity
- Bleeding disorders (inherited or acquired).
- Clinically significant cardiovascular disease.
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- Active infection (including tuberculosis, hepatitis C, syphilis).
- Pregnant or breastfeeding women.
- Severe systemic or psychiatric illness.
- Prior cell or gene therapy.
- Severe drug hypersensitivity history.
- Investigator-assessed unsuitability for trial participation. -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Gobroad Hospital
Beijing, Beijing Municipality, 100000
Qi Changsong Beijing Goabroad Hospital, xiwangpku@126.com
- Not yet recruiting
GoBroad Healthcare Group
Beijing, Beijing Municipality, 102206
Changsong Qi, +8601050847838, xiwangpku@126.com
About this study
Official title: A Preliminary Clinical Study of TC-G203 for Patients With GPC3-Positive Recurrent/Metastatic Solid Tumors
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-G203 in patients with GPC3-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
Read the detailed description
This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of TC-G203 therapy in patients with recurrent or metastatic solid tumors. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) TC-G203 infusion, and (5) post-infusion follow-up.
- Being tested
- TC-G203 cells treatment
- Keywords
- Solid Cancer, GPC3 positive hepatocellular carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-G203 cells treatmentBiological
Also called Cyclophosphamide, Fludarabine
TC-G203 CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
| Study group | Role | What they receive |
|---|---|---|
| TC-G203 Cell Therapy | Experimental | TC-G203 CAR-T Cells Following lymphodepletion chemotherapy, participants will receive TC-G203 CAR-T cell infusion. Receives: Biological: TC-G203 cells treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD)
DLT is defined as any CAR-T cell-related adverse event graded per ASTCT 2019 CRS criteria and NCI CTCAE v5.0, including: ≥Grade 4 hematologic toxicity not recovering to ≤Grade 2 by Day 28, ≥Grade 4 CRS lasting ≥3 days, ≥Grade 3 ICANS, or ≥Grade 3 non-hematologic toxicity lasting >7 days (excluding fever, fatigue, nausea/vomiting).
Measured: Within 28 days after TC-G203 infusion
Secondary outcomes (1)
Tumor Response and Survival Outcomes
Objective Response Rate (ORR): Number of participants with complete response (CR) or partial response (PR) Duration of Response (DOR): Time from first documented response to disease progression or death Progression-Free Survival (PFS): Time from TC-G203 infusion to disease progression or death Overall Survival (OS): Time from TC-G203 infusion to death from any cause
Measured: 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 posted21 Nov 2025
- Study start18 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancerStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242417
- Sponsor's protocol ID
- G203-IIT-01
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 21 Jan 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Clinical Study of TC-G203 for Patients With GPC3-Positive Recurrent/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07242417
- Acronym / sponsor ID
- G203-IIT-01
- Keywords
- Solid Cancer, GPC3 positive hepatocellular carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 21 Nov 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 is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-G203 in patients with GPC3-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
Detailed description
This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of TC-G203 therapy in patients with recurrent or metastatic solid tumors. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) TC-G203 infusion, and (5) post-infusion follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TC-G203 Cell Therapy | Experimental | Biological: TC-G203 cells treatmentTC-G203 CAR-T Cells Following lymphodepletion chemotherapy, participants will receive TC-G203 CAR-T cell infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must voluntarily provide written informed consent.
- Aged 18-75 years (inclusive).
- Life expectancy ≥ 12 weeks.
- ECOG performance status 0-1.
- Failed or unsuitable for standard therapy.
Key exclusion criteria (12 listed)
- Primary CNS malignancy or uncontrolled CNS metastases.
- Other malignancies within 5 years
- Active autoimmune disease or history of autoimmune disease.
- Immunodeficiency, including HIV positivity
- Bleeding disorders (inherited or acquired).
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 |
|---|---|---|
| TC-G203 cells treatmentAlso: Cyclophosphamide, FludarabineTC-G203 CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide. | Biological | TC-G203 Cell Therapy |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD)
Time frame: Within 28 days after TC-G203 infusion
DLT is defined as any CAR-T cell-related adverse event graded per ASTCT 2019 CRS criteria and NCI CTCAE v5.0, including: ≥Grade 4 hematologic toxicity not recovering to ≤Grade 2 by Day 28, ≥Grade 4 CRS lasting ≥3 days, ≥Grade 3 ICANS, or ≥Grade 3 non-hematologic toxicity lasting >7 days (excluding fever, fatigue, nausea/vomiting).
1 secondary outcome
Tumor Response and Survival Outcomes
Time frame: 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 21 Jan 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.
2 sites 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 TC-G203 cells treatment in people with Solid Cancer and GPC3 Positive Hepatocellular Carcinoma, run by Beijing GoBroad Hospital 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 10 inclusion and 12 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 21 Jan 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?
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 Changsong Qi (+8601050847838, xiwangpku@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLT) and Maximum Tolerated Dose (MTD) (time frame: Within 28 days after TC-G203 infusion). 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 21 Jan 2026.