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Clinical Trials in China / NCT06951425
Starting soon Phase EARLY_PHASE1

An Exploratory Clinical Study of the Efficiency and Safety of TH027 in the Treatment of Relapsed/Refractory Solid Tumors

NCT06951425 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine
Phase
Phase EARLY_PHASE1
Started
2025-06-01
Last updated
2025-05-13

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

TH-CART-027

TH-CART-027: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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); * 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. Exclusion Criteria: * 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); * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Tongji Hospital, Tongji University School of Medicine Shanghai China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06951425 on ClinicalTrials.gov ↗ ← All trials in China