Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT05583201

NKG2D/CLDN18.2 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumors

Led by jianming xu · Updated on 2023-02-08

18

Participants Needed

1

Research Sites

189 weeks

Total Duration

On this page

Sponsors

J

jianming xu

Lead Sponsor

K

KAEDI

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D/CLDN18.2-based CAR-T cells infusion in the treatment of advanced NKG2DL+/CLDN18.2+ solid tumors.

CONDITIONS

Official Title

NKG2D/CLDN18.2 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with advanced solid tumors such as gastric or pancreatic cancer confirmed by pathology or cytology
  • Failed standard treatment, cannot tolerate standard treatment, or no standard treatment exists as per NCCN or CSCO guidelines
  • Aged between 18 and 75 years
  • ECOG performance status score of 0 or 1
  • Expected survival of at least 3 months
  • Meet coagulation requirements and have adequate peripheral venous access for apheresis with sufficient PBMC to manufacture CAR T cells
  • Positive for NKG2DL and CLDN18.2 markers confirmed by immunohistochemistry with a positive score of 5 or more; biopsy tissue must be recent (within 2 years) or a new biopsy must be obtained
  • Adequate organ and bone marrow function, including specified blood counts, liver and kidney function, coagulation, lung function (grade 1 dyspnea or less, SaO2 ≥91%), and cardiac function (LVEF ≥50%)
  • Have measurable lesions according to RECIST 1.1
  • If positive for hepatitis B surface or core antibodies, HBV-DNA must be below 2000 IU/ml; antiviral therapy must be received if HBsAg positive
  • Understand the study and voluntarily sign informed consent
  • Agree to use approved contraceptive methods during the study and for at least 13 months after the last cell infusion until no CAR-T cells are detected by two consecutive PCR tests
Not Eligible

You will not qualify if you...

  • Active HIV infection, active hepatitis B with HBV DNA ≥500 IU/ml, or hepatitis C with detectable HCV RNA
  • Previous gene therapy or T cell therapy including CAR-T cell therapy
  • Participation in other drug trials within 4 weeks prior to enrollment
  • Active or recent (within 1 year) tuberculosis infection
  • Sudden pulmonary disease, interstitial lung disease, pulmonary fibrosis, or acute pulmonary disease
  • Pre-existing or active autoimmune diseases or high risk for recurrence, except stable type 1 diabetes, autoimmune hypothyroidism on hormone therapy, or mild skin conditions not requiring systemic treatment
  • Severe heart disease including poorly controlled hypertension, QT prolongation, congestive heart failure (NYHA class ≥II), recent cardiac events or procedures within 6 months
  • Symptomatic brain metastases except stable, asymptomatic brain metastases treated at least 14 days prior
  • Other central nervous system disorders affecting the trial, such as epilepsy, stroke, dementia, or autoimmune CNS diseases
  • Complicating hematologic cancer or other primary malignant solid tumors except certain treated cervical or breast cancer or successfully removed orthotopic tumors
  • Recent cytotoxic treatment, targeted therapy, monoclonal antibodies, immunomodulators, or radiotherapy within specified time frames before apheresis
  • Pregnant or breastfeeding women
  • History of severe hypersensitivity to study agents or prophylactic drugs used in pretreatment
  • Untreated brain metastases or brain metastases symptoms
  • Heart disease or uncontrolled high blood pressure requiring treatment
  • Unstable or active peptic ulcers or gastrointestinal bleeding
  • History of or preparation for organ transplantation
  • Need for anticoagulant or high-dose antiplatelet therapy
  • Recent major surgery or serious injury within 4 weeks prior to study
  • Toxicity greater than grade 1 from prior cancer therapy except alopecia
  • Any other condition deemed inappropriate by researchers

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

Chinese PLA General Hospital

Beijing, China

Actively Recruiting

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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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