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

NCT06951425 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: TH027-ST001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Six months post CAR-T cells infusion.

Secondary Outcomes (4)

• Overall survival (OS)

  12 and 24 months post CAR-T cells infusion.

• Objective response rate (ORR)

  3 months post CAR-T cells infusion.

• Progression Free Survival (PFS)

  1 year post CAR-T cells infusion.

• Disease Control Rate (DCR)

  1 year post CAR-T cells infusion

Study Arms (1)

Treatment of B7H3+ solid tumors

EXPERIMENTAL

Intraperitoneal Infusion for Ovarian Cancer and Peritoneal Metastatic Tumors; Intravenous Infusion for Other Types of Solid Tumors

Drug: TH-CART-027

Interventions

TH-CART-027 DRUG

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

Treatment of B7H3+ solid tumors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine: lead
• ThinkingBiomed: collaborator

Study Sites (1)

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, China

Location

Central Study Contacts

Liying Chen

CONTACT

+86 15618670468; lab7182@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician, Vice President of Tongji Hospital, Tongji University School of Medicine etc.

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 30, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)