A Clinical Study of CHT102 in Mesothelin Positive Advanced Solid Tumors

Official title

A Clinical Study of CHT102, a Universal Chimeric Antigen Receptor T-Cell Immunotherapy(U CAR-T) for Mesothelin(MSLN) Positive Advanced Solid Tumors: a Single-arm, Open-label, Dose Escalation and Expansion Clinical Study

Overview

Objectives of Study：In this study investigators plan to evaluate the safety and efficacy of MSLN-targeting Universal Chimeric Antigen Receptor T-Cell Immunotherapy(U CAR-T) in the treatment of MSLN-positive advanced solid tumors.

Interventions

• Biological CHT102 allogeneic CAR T cells
  CHT102 allogeneic CAR T cells

Primary outcome measures

• Dose Limiting Toxicities (DLTs) occurence [Time frame: Baseline up to 28 days after U CAR-T infusion]

Secondary outcome measures (2)

• Objective Response Rate [Time frame: At 4 weeks, and overall]
• Progression-free survival [Time frame: Assessed up to 6 months]

Eligibility criteria

Inclusion criteria

• Ability to understand and sign a written informed consent document；
• Age ≥18 years old, male or female；
• Histopathological confirmed advanced or metastatic solid tumors failed to at least standard first-line therapy or initially diagnosed advanced solid tumors that have no National Comprehensive Cancer Network (NCCN ）guideline recommended standard first-line therapy；
• Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor MSLN expression (tumor MSLN positive (IHC 2+) confirmed by histology or pathology));
• At least one measurable lesion at baseline per RECIST version 1.1；
• The expected survival time is more than 12 weeks;
• ECOG(American Eastern Oncology Consortium) 0-1 points;
• The function of important organs is basically normal;
• The investigator determines that the patient must have fully recovered from previous treatment toxicity to ≤ grade 1, except in the following cases: a. Hair loss; b. Pigmentation; c. Long-term toxicity caused by radiotherapy, which could not be recovered according to the investigators; d. Platinum induced grade 2 or lower neurotoxicity (CTCAE 5.0);
• Subjects agree to use reliable and effective contraceptive methods for contraception within
• 6 months after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception).

Exclusion criteria

• Received any experimental drug treatment or used experimental devices within 28 days;
• Received anti-tumor therapy such as chemotherapy and targeted therapy within 4 weeks;
• Received cell therapy products other than MSLN targets within 1 month;
• Patients who have previously received other cell therapy products should be tested for RCL(Replication Competent Retrovirus ) during the screening period if any test result is positive;
• Received chemotherapy other than lymphocyte clearance chemotherapy within 14 days prior to CHT102 infusion;
• Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks；
• Patients receiving oral or intravenous anticoagulant therapy within 7 days prior to CHT102 cell infusion;
• Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation;
• Patients with immune deficiency or autoimmune diseases, or who require immunosuppressants;
• Vaccination within 14 days of study enrollment, or who required live vaccine immunization during the study period;
• Active/symptomatic central nervous system metastases or meningeal metastases at the time of screening; subjects with brain metastases who have been treated must be confirmed to have no imaging evidence of progression ≥ 4 weeks after the end of treatment before they can be enrolled;
• Serious or uncontrollable systemic disease or any unstable systemic disease, including but not limited to uncontrolled hypertension, uncontrolled hyperglycemia, liver and kidney insufficiency or metabolic disease, central nervous system disease, etc;
• Have any of the following heart conditions:
• New York Heart Association (NYHA) stage III or IV congestive heart failure;
• Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
• Clinically significant ventricular arrhythmia,
• echocardiography showed cardiac ejection fraction<50%, QTc (male)>450 ms，QTc (female)>470 ms；;
• Pregnant, lactating, or breastfeeding females;
• Patients with poor control of thoracoabdominal water;
• Other investigators deem it inappropriate to participate in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Tianjin Medical University Cancer Institute & Hospital — Tianjin

Identifiers

NCT: NCT06717022 · CHT102SIIT-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗