Solid TumorsEarly Phase 1NCT06951425
An Exploratory Clinical Study of the Efficiency and Safety of TH027 in the Treatment of Relapsed/Refractory Solid Tumors
A Early Phase 1 study testing TH-CART-027 in people with Solid Tumors, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
Trial summary
This is a Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerabilityand Antitumor Activity of TH027 CAR-T Cell lnjection (TH-CART-027) in Subjects With Relapsed or Refractory 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?
- TH-CART-027
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Nov 2028
- 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.The patients were aged from 18 to 75 years old (including the cut-off value), and the gender was not limited;
- 2.The expected survival time was more than 12 weeks;
- 3.ECOG score was 0-2;
- 4.One of the following tumor types was confirmed by pathology: osteosarcoma, neuroblastoma, gastric cancer or lung cancer, and the positive rate of CD276 expression in tumor tissue was more than 30% by immunohistochemistry;
- 5.Patients with ineffective standard treatment methods (such as postoperative recurrence, chemotherapy, radiotherapy, and progression after targeted drugs);
- 6.According to RECIST 1.1, there was at least one measurable lesion (the longest diameter of solid lesion >=10 mm, or the short diameter of lymph node lesion >=15 mm);
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- 7.The function of main organs was normal (white blood cell count >= 3 × 10^9 / L, neutrophil count >= 1.5 × 10^9 / L, hemoglobin >= 8.5g/dl, platelet count >= 80 × 10^9 / L and lymphocyte count at 1 × 10^9 / L (including) ~ 4 × 10^9 / L (inclusive);
- 8.The liver and kidney function and cardiopulmonary function meet the following requirements:
- Urea and serum creatinine <= 1.5 × ULN；
- Left ventricular ejection fraction >= 50%;
- Baseline oxygen saturation >= 94%;
- Total bilirubin <= 1.5 × ULN； ALT and AST <= 2.5 × ULN；
- 9.The patient or legal representative can fully understand the significance and risk of this trial and has signed the informed consent.
Who cannot join
- 1.Patients with history of immune deficiency or autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); Patients with graft-versus-host disease (GVHD) or need immunosuppressive agents;
- 2.There was a history of other second malignancies in 5 years before screening;
- 3.Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) were positive, and the peripheral blood HBV DNA titer was not within the normal reference value; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis was positive;
- 4.Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification >= III), severe arrhythmia;
- 5.Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- 6.Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);
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- 7.Pregnant or lactating women, female subjects who plan to conceive within one year after cell transfusion, or male subjects whose partners plan to conceive within one year after cell transfusion;
- 8.Patients who had received CAR-T therapy or other gene modified cell therapy before screening;
- 9.The subjects who were receiving systemic steroid treatment within 7 days before the screening or who needed long-term systemic steroid treatment (except inhalation or local use) were determined by the researchers;
- 10.The ascites increased gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding ascites drainage);
- 11.According to the judgment of the researcher, it does not conform to the situation of cell preparation;
- 12.Other researchers think that it is not suitable for inclusion.
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
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai
Liying Chen, +8615618670468, lab7182@tongji.edu.cn
About this study
Official title: A Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerability and Antitumor Activity of TH027 CAR-T Cells (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors
This is a Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerabilityand Antitumor Activity of TH027 CAR-T Cell lnjection (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors.
- Conditions
- Solid Tumors
- Being tested
- TH-CART-027
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TH-CART-027Drug
3+3 dose escalation design: Dose Level 1: 0.3×10^6 CAR+ T cells /kg; Dose Level 2: 1.0×10^6 CAR+ T cells /kg; Dose Level 3: 3.0×10^6 CAR+ T cells /kg
| Study group | Role | What they receive |
|---|---|---|
| Treatment of B7H3+ solid tumors | Experimental | Intraperitoneal Infusion for Ovarian Cancer and Peritoneal Metastatic Tumors; Intravenous Infusion for Other Types of Solid Tumors Receives: Drug: TH-CART-027 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety：Incidence of Dose Limiting Toxicity (DLT)
Limiting toxicity type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TH-CART-027 infusion
Measured: 28 days after the first TH-CART-027 infusion.
Safety：Incidence and severity of adverse events (AEs)
To evaluate possible adverse events after TH-CAPT-027 infusion, including the incidence and severity of AEs.
Measured: Six months post CAR-T cells infusion.
Secondary outcomes (4)
Overall survival (OS)
Time from treatment initiation to death from any cause.
Measured: 12 and 24 months post CAR-T cells infusion.
Objective response rate (ORR)
The assessment will be based on the investigator's evaluation of imaging evaluations, with efficacy evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). ORR refers to the proportion of patients with objective evidence of achieving a Complete Response (CR) or Partial Response (PR). Where applicable, responses recorded after disease progression or initiation of non-investigational anticancer therapy will be excluded.
Measured: 3 months post CAR-T cells infusion.
Progression Free Survival (PFS)
Defined as the time from initiation of the investigational drug to the first occurrence of progressive disease (PD) or death from any cause in the absence of documented PD. If no tumor progression is observed and the subject does not die during the study period, the analysis cutoff date will be determined as the date of the last tumor assessment.
Measured: 1 year post CAR-T cells infusion.
Disease Control Rate (DCR)
Defined as the proportion of patients achieving Partial Response (PR), Complete Response (CR), or Stable Disease (SD) according to RECIST 1.1 criteria, relative to the total number of cases in the study.
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.
- First posted30 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- ThinkingBiomed
- Responsible party
- Principal investigator, Aibin Liang, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951425
- Sponsor's protocol ID
- TH027-ST001
- Status last verified
- May 2025
- First submitted
- 20 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerability and Antitumor Activity of TH027 CAR-T Cells (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT06951425
- Acronym / sponsor ID
- TH027-ST001
- Conditions
- Solid Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Collaborators
- ThinkingBiomed
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 30 Apr 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 Phase l, Open-Label, Dose-escalation Study to Evaluate the Safety, Tolerabilityand Antitumor Activity of TH027 CAR-T Cell lnjection (TH-CART-027) in Subjects With Relapsed or Refractory Solid Tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of B7H3+ solid tumors | Experimental | Drug: TH-CART-027Intraperitoneal Infusion for Ovarian Cancer and Peritoneal Metastatic Tumors; Intravenous Infusion for Other Types of Solid Tumors |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1.The patients were aged from 18 to 75 years old (including the cut-off value), and the gender was not limited;
- 2.The expected survival time was more than 12 weeks;
- 3.ECOG score was 0-2;
- 4.One of the following tumor types was confirmed by pathology: osteosarcoma, neuroblastoma, gastric cancer or lung cancer, and the positive rate of CD276 expression in tumor tissue was more than 30% by immunohistochemistry;
- 5.Patients with ineffective standard treatment methods (such as postoperative recurrence, chemotherapy, radiotherapy, and progression after targeted drugs);
Key exclusion criteria (12 listed)
- 1.Patients with history of immune deficiency or autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, insulin-dependent diabetes, etc.); Patients with graft-versus-host disease (GVHD) or need immunosuppressive agents;
- 2.There was a history of other second malignancies in 5 years before screening;
- 3.Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) were positive, and the peripheral blood HBV DNA titer was not within the normal reference value; HCV antibody and HCV RNA in peripheral blood were positive; HIV antibody positive patients; Syphilis was positive;
- 4.Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification >= III), severe arrhythmia;
- 5.Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
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 |
|---|---|---|
| TH-CART-0273+3 dose escalation design: Dose Level 1: 0.3×10^6 CAR+ T cells /kg; Dose Level 2: 1.0×10^6 CAR+ T cells /kg; Dose Level 3: 3.0×10^6 CAR+ T cells /kg | Drug | Treatment of B7H3+ solid tumors |
Primary outcome
Safety：Incidence of Dose Limiting Toxicity (DLT)
Time frame: 28 days after the first TH-CART-027 infusion.
Limiting toxicity type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TH-CART-027 infusion
Safety：Incidence and severity of adverse events (AEs)
Time frame: Six months post CAR-T cells infusion.
To evaluate possible adverse events after TH-CAPT-027 infusion, including the incidence and severity of AEs.
4 secondary outcomes
Overall survival (OS)
Time frame: 12 and 24 months post CAR-T cells infusion.
Objective response rate (ORR)
Time frame: 3 months post CAR-T cells infusion.
Progression Free Survival (PFS)
Time frame: 1 year post CAR-T cells infusion.
Disease Control Rate (DCR)
Time frame: 1 year post CAR-T cells infusion
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 13 May 2025.
- 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.
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 TH-CART-027 in people with Solid Tumors, run by Shanghai Tongji Hospital, Tongji University School of Medicine 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 13 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: opening soon, as of the sponsor's last update on 13 May 2025. 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 Liying Chen (+86 15618670468, lab7182@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety：Incidence of Dose Limiting Toxicity (DLT) (time frame: 28 days after the first TH-CART-027 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 13 May 2025.