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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SUV2208A cell injection, SUV2208A, SUV2208A.
- Who it may be relevant to
- Registry conditions: CLDN18.2 Positive Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This study is an open, single/multiple infusion, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of CAR-CLDN18.2 T cell therapy, and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with positive claudin 18.2 expression and failed to standard systemic treatment.
Interventions
- Biological SUV2208A cell injection
SUV2208A, DL1, 2 times, Day 0 and Day 28, IV - Biological SUV2208A
SUV2208A, DL2, 2 times, Day 0 and Day 28, IV - Biological SUV2208A
SUV2208A, DL3, 2 times, Day 0 and Day 28, IV
Primary outcome measures
- DLT [Time frame: within 24 days from Day 0]
- AE/SAE [Time frame: within 2 years from Day 0]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital Of Anhui Medical University — Hefei
Identifiers
NCT: NCT07680257 · SUV2208A-01