Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2024-01-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAR-CLDN18.2 T-Cells

The subjects enrolled will be sequentially assigned to the corresponding dose level.

Group Type EXPERIMENTAL

CAR-CLDN18.2 T-Cells

Intervention Type DRUG

Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses

• Chimeric Antigen Receptor T Cells Targeting Claudin18.2

Cohort 1

CT041 monotherapy in patients with GI cancers who failed standard chemotherapy

Group Type EXPERIMENTAL

CAR-CLDN18.2 T-Cells

Intervention Type DRUG

Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses

• Chimeric Antigen Receptor T Cells Targeting Claudin18.2

Cohort 2

CT041 plus anti-PD1 therapy in patients with GI cancers who failed standard chemotherapy

Group Type EXPERIMENTAL

CAR-CLDN18.2 T-Cells

Intervention Type DRUG

Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses

• Chimeric Antigen Receptor T Cells Targeting Claudin18.2

PD-1 Monoclonal Antibody

Intervention Type DRUG

Chimeric Antigen Receptor T Cells Targeting Claudin18.2 with PD-1

Cohort 3

CT041 sequential treatment after first-line therapy in GC/GEJ

Group Type EXPERIMENTAL

CAR-CLDN18.2 T-Cells

Intervention Type DRUG

Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses

• Chimeric Antigen Receptor T Cells Targeting Claudin18.2

Chemotherapy

Intervention Type DRUG

First-line systemic therapy according to physician's choice

Cohort 4

prior treatment failure to anti-CLDN18.2 monoclonal antibody

Group Type EXPERIMENTAL

CAR-CLDN18.2 T-Cells

Intervention Type DRUG

Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses

• Chimeric Antigen Receptor T Cells Targeting Claudin18.2

Interventions

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CAR-CLDN18.2 T-Cells

Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses

• Chimeric Antigen Receptor T Cells Targeting Claudin18.2

Intervention Type DRUG

PD-1 Monoclonal Antibody

Chimeric Antigen Receptor T Cells Targeting Claudin18.2 with PD-1

Intervention Type DRUG

Chemotherapy

First-line systemic therapy according to physician's choice

Intervention Type DRUG

Other Intervention Names

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Chimeric Antigen Receptor T Cells Targeting Claudin18.2 Toripalimab

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 to 75 years, male or female;
2. Subjects with pathologically confirmed solid tumors (ie, advanced gastric cancer, esophagogastricgastroesophageal junction cancer, and pancreatic cancer) and have been failed to at least first-one prior line of systemic treatment;
3. Tumor tissue samplessample was positive for claudin 18.2 positive through for claudin18.2 IHC staining;assay(≥2+, and ≥40%);
4. Estimated life expectancy \> 12 weeks;
5. According to the RECIST 1.1, there is at least one measurable or unmeasurable tumor lesionslesion；
6. ECOG physical status score 0 \~ 1, within 24 hours prior to apheresis, and at baseline (prior to pre-treatment);
7. Sufficient venous access for mononuclear cell collection (abbreviation: apheresis)
8. Subjects should have adequate organ functions before screening and pre-treatment (at baseline).
9. Female subjects of childbearing age must undergo a serum pregnancy test at screening and prior to preconditioning and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment. The methods that can be used are: bilateral tubal ligation / bilateral salpingectomy or bilateral tubal occlusion; or approved oral, injection or hormone-imparting contraceptive methods; or barrier contraceptive method: containing spermicidal foam / Gel/film/cream/suppository condom or occlusive cap (diaphragm or cervix/cap);
11. Subject participates in this clinical trial and sign Informed Consent Form voluntarily.

Exclusion Criteria

1. Pregnant or lactating women;
2. HIV, Treponema pallidum or HCV serologically positive;
3. Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection (HBsAg positive, or HBcAb positive and HBV DNA positive);
4. Subjects have clinically significant thyroid dysfunction determined by investigator (serum thyroid hormone assays TT4, TT3, FT3, FT4, and serum thyroid stimulating hormone TSH) which is not suitable for entering into the study;
5. The side effects caused by the previous treatment of the subjects did not return to CTCAE ≤1; except hair loss and, hyperpigmentation or other tolerable events determined by investigator or laboratory abnormalities allowed by the protocol;
6. Subjects who are using steroidshave recieved ≥15 mg/day glucocorticoid systemically currently within 7 days prior to apheresis; those using inhaled steroids recently or currently are not excluded;
7. Previously allergic to immunotherapy and related drugs, history of severe allergiespreconditioning drug such as cyclophosphamide, fludarabine, or allergiestocilizumab or allergic to components of CT041CAR-CLDN18.2T injection, allergic to β-lactam antibiotics;the CT041 infusion;
8. Previously received any chimeric antigen receptor-modified T-cells(including CAR-T、TCR-T) .
9. Subjects have untreated or symptomatic brain metastases;
10. Subjects have central or extensivelywith centralcor diffused metastases in lung and .extensiveor diffused metastases in liver;liveror with rapid tumor progression since screening period evaluated by the investigator preconditioning (at baseline)；
11. The largest target tumor lesion\>4cm
12. Subjects with unstable or active ulcers and gastrointestinal bleeding currently;
13. Subjects with a history of organ transplantation or awaiting organ transplantation;
14. Subjects requiring anticoagulant therapy;
15. Subjects requiring continuous anti-platelet therapy;
16. Subjects who have undergone major surgery or significant trauma within 4 weeks prior to apheresis, or who are expected to undergo major surgery during the study;
17. There are no other serious diseases that may limit subjects' participation in this trial;
18. The investigator assessed that the subject was unable or unwilling to comply with the requirements of the study protocol;
19. Blood oxygen saturation ≤ 95% before pre-treatmentapheresis or preconditioning (accept finger oxygen detection method);
20. Prior to pretreatmentpreconditioning, subjects developed, including but not limited to, new arrhythmias that could not be controlled with drugs, hypotension requiring pressor agent, bacterial, fungal or viral infections that required intravenous antibiotics. Creatinine clearance rate \<40mL / min; The investigator judges that the subject is not suitable for continuing the trial. Subjects who use antibiotics to prevent infection can continue the trials if judged by the investigator;
21. The subject has a central nervous system disease sign or an abnormal neurological test result with clinical significance;
22. The subject is currently suffered from or have suffered from other incurable malignant tumors within previous 3 years, except in situ cervical cancer or skin basal cell cancer.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No