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NCT06951425 | NOT YET RECRUITING | Solid Tumors

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

Shanghai Tongji Hospital, Tongji University School of Medicine

Information provided by (Responsible Party):

AI is more expensive than NL i

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 Solid Tumors.

Condition or disease

Solid Tumors

Intervention/treatment

TH-CART-027

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2028-11-30
Estimated Study Completion Date : 2028-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
An Exploratory Clinical Study of the Efficiency and Safety of TH027 in the Treatment of Relapsed/Refractory Solid Tumors

Location Details

NCT06951425

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How to Participate

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Locations

Not yet recruiting

China, Beijing

ThinkingBiomed (Beijing) Co.,Ltd.

Beijing, Beijing, China, 100176