Actively Recruiting

Early Phase 1
Age: 18Years - 70Years
All Genders
NCT05539833

KSH01-TCRT Solid Tumors

Led by TCRx Therapeutics Co.Ltd · Updated on 2023-04-03

50

Participants Needed

1

Research Sites

258 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

1\) Safety and efficacy of TCR-T cells in subjects with refractory/relapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.

CONDITIONS

Official Title

KSH01-TCRT Solid Tumors

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate and able to complete all study procedures
  • Male or female aged 18 to 70 years inclusive
  • Confirmed advanced malignant solid tumors by histology or cytology
  • For dose escalation: no standard treatment available, or failed/relapsed standard treatment, or intolerant to standard treatment with positive target expression
  • For dose expansion: target-positive subjects progressed after first-line therapy
  • HLA-A*02 positive and tumor target positive with >30% cancer cells showing 2+ or 3+ staining intensity
  • Previous anti-tumor therapy toxicities resolved to grade 0-1 or acceptable level except alopecia and vitiligo
  • Adequate organ function without recent medical support including blood transfusion or growth factors
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Expected survival of at least 12 weeks
  • At least one measurable lesion by RECIST 1.1 criteria (dose expansion) or evaluable lesion (dose escalation)
  • Sufficient peripheral blood mononuclear cells available for TCR-T cell preparation
  • Prepared autologous TCR-T cells meet quantity and quality standards for reinfusion
  • Female participants of childbearing potential have negative pregnancy test within 3 days before reinfusion and agree to use effective contraception until 6 months after last treatment
  • Male participants agree to abstain or use effective contraception until 6 months after last treatment and not donate sperm during this period
  • Provide tumor tissue specimens for target analysis, either archived or fresh biopsy (excluding bone biopsy)
Not Eligible

You will not qualify if you...

  • History of severe allergic diseases or severe drug allergies including test drugs
  • Previous coronary artery reconstruction
  • Significant bleeding disorders or high bleeding risk conditions
  • Recent thrombosis or embolism within 6 months before reinfusion
  • Clinically significant bleeding events within 1 month before reinfusion
  • Use of anticoagulants (except low molecular weight heparin) within 2 weeks before reinfusion
  • Use of certain antiplatelet drugs within 10 days before reinfusion
  • Recent treatments including unhealed wounds, live vaccines, or specific chemotherapy drugs within defined periods before reinfusion
  • Recent corticosteroid use except limited short-term or topical use
  • Known leptomeningeal or symptomatic uncontrolled central nervous system metastases
  • Any form of primary immunodeficiency
  • Active or expected relapsing autoimmune diseases except certain controlled or non-systemic conditions
  • Major cardiovascular events or conditions within 6 months before reinfusion
  • Uncontrolled pleural, pericardial, or ascitic effusions
  • Specific cardiac abnormalities or poor heart function
  • Poorly controlled diabetes or hypertension
  • Reduced lung function or need for supplemental oxygen
  • Unexplained fever above 38.5°C during screening or before reinfusion
  • History of allogeneic organ transplantation
  • History of alcohol, psychotropic substance, or drug abuse
  • History of neurological or mental disorders such as epilepsy or schizophrenia
  • Known AIDS diagnosis
  • Severe active infections or positive viral tests (HIV, CMV, HSV, HPV, EBV, syphilis)
  • Active hepatitis B or C infection above specified thresholds
  • Conditions increasing risk or confounding safety evaluations per investigator judgment
  • Expected to receive other antitumor treatments during study
  • Pregnant or breastfeeding women
  • Any other conditions deemed unsuitable by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The first affiliated hospital of Guang Xi medical university

Nanning, Guangxi, China, 530000

Actively Recruiting

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Research Team

C

clinical trials ksh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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