Status:
NOT_YET_RECRUITING
An Exploratory Clinical Study of the Efficiency and Safety of TH027 in the Treatment of Relapsed/Refractory Solid Tumors
Lead Sponsor:
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborating Sponsors:
ThinkingBiomed
Conditions:
Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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 Soli...
Eligibility Criteria
Inclusion
- The patients were aged from 18 to 75 years old (including the cut-off value), and the gender was not limited;
- The expected survival time was more than 12 weeks;
- ECOG score was 0-2;
- 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;
- Patients with ineffective standard treatment methods (such as postoperative recurrence, chemotherapy, radiotherapy, and progression after targeted drugs);
- 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);
- 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);
- 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；
- The patient or legal representative can fully understand the significance and risk of this trial and has signed the informed consent.
Exclusion
- 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;
- There was a history of other second malignancies in 5 years before screening;
- 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;
- 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;
- Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection);
- 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;
- Patients who had received CAR-T therapy or other gene modified cell therapy before screening;
- 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;
- The ascites increased gradually after 2 weeks of conservative treatment (such as diuresis, sodium restriction, excluding ascites drainage);
- According to the judgment of the researcher, it does not conform to the situation of cell preparation;
- Other researchers think that it is not suitable for inclusion.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06951425
Start Date
June 1 2025
End Date
November 30 2028
Last Update
May 13 2025
Active Locations (1)
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1
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, China