An Early Clinical Study to Evaluate the Safety and Efficacy of CLDN18.2 CAR T Cell Injection in Subjects With CLDN18.2-Positive Advanced Malignant Solid Tumors
SUV2208A cell injection: SUV2208A, DL1, 2 times, Day 0 and Day 28, IV
SUV2208A: SUV2208A, DL2, 2 times, Day 0 and Day 28, IV
SUV2208A: SUV2208A, DL3, 2 times, Day 0 and Day 28, IV
Study summary
An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Willing to sign the Informed Consent Form (ICF) and comply with predefined visits and related procedures;
* Age 18 to 75, male or female;
* Cytology or histology confirmed advanced malignant solid tumors, with moderate to high expression of CLDN18.2;
* Locally advanced or metastatic solid tumors that are failed of, or refractory to, or contraindicated for standard of care;
* ECOG PS 0-1;
* The life expectency ≥ 3 months;
* Has sufficient organ and bone marrow function.
Exclusion Criteria:
* Have active central nervous system metastases or infiltration;
* Has previously received a bone marrow or organ transplant (including, but not limited to, a liver transplant) or is awaiting a transplant;
* History of or concurrent other malignancies (cured cervical carcinoma in situ with no recurrence within at least 2 years prior to screening, non-invasive basal cell or squamous cell carcinoma of the skin, locally advanced prostate cancer treated with radical surgery, or post-radical surgery ductal carcinoma in situ may be eligible for the study).
* Infectious disease;
* Adverse events caused by prior anti-tumor therapy that have not resolved to grade 1 or baseline, except for alopecia, grade 2 peripheral neuropathy, and stable hypothyroidism with hormone replacement therapy;
* Have received live attenuated vaccine within one month before screening, or plan to receive live attenuated vaccine during the study;
* Have major surgery (except liver space-occupying biopsy) within one month before screening, or have planned major surgery during the study.
Primary outcome measure(s)
DLT — within 24 days from Day 0 DLT incidence within 24 days after infusion of SUV2208A.
AE/SAE — within 2 years from Day 0 The incidence, severity, and corelaton of adverse events (AE) and serious adverse events (SAE).
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital Of Anhui Medical University
Hefei
Anhui
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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