A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors

ConditionsColorectal Cancer Solid Cancers Gastric Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorWeijia Fang, MD

About this trial

This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old, male or female;

Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer;

After receiving at least second-line standard treatment and failing (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods;

Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); If over 3 months, the patient's serum CEA should exceed 10ug/L.

Disqualifiers

CNS metastases or meningeal metastases with clinical symptoms at the time of screening, or there is other evidence that the patient's central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for inclusion;

Participated in other clinical studies within 1 month before screening;

vaccinated with live attenuated vaccine within 4 weeks before screening;

Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);

Trial design

Design model

Parallel

Treatments tested in this trial

Intraperitoneal infusion of FAST CEA-targeted CAR-T
Biological/Vaccine
Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13); Subjects will be treated with Fludarabine and Cyclophosphamide based lymphodepleting chemotherapy before CAR-T cell infusion.
CEA CAR-T cells
Biological/Vaccine
Administration method: intravenous infusion or intraperitoneal injection； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
CEA CAR-T cells
Biological/Vaccine
Administration method: intravenous infusion or intraperitoneal injection； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Treatment groups

110 Participants

are divided into 3 treatment groups

Group A: Intraperitoneal infusion of FAST CEA-targeted CAR-TExperimental treatment 1 intervention

Group B: Intravenous of CEA-targeted CAR-TExperimental treatment 1 intervention

Group C: intraperitoneal injection of CEA-targeted CAR-TExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of Adverse events after CEA-CAR-T cells infusion [Safety and Tolerability]

Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

Time frame

28 days

Obtain the maximum tolerated dose of CEA-CAR-T cells[Safety and Tolerability]

Dose-limiting toxicity after cell infusion

Time frame

28 days

Secondary outcomes

Disease control rate of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]

Disease control rate: including CR, PR and SD

Time frame

3 months

Changes in serum tumor markers of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]

Changes in serum tumor markers：CEA、 CA199、 CA125

Time frame

3 months

AUCS of CEA-CAR-T cells [Cell dynamics]

AUCS is defined as the area under the curve in 28 days and 90 days

Time frame

1 years

CMAX of CEA-CAR-T cells [Cell dynamics]

CMAX is defined as the highest concentration of CEA-CAR-T cells expanded in peripheral blood

Time frame

1 years

Other outcomes

Objective response rate (ORR) of CEA- CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]

Objective response rate includes：CR、PR

Time frame

1 years

Duration of Response (DOR) of CEA- CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]

DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause

Time frame

1 years

Progress-free survival(PFS) of CEA- CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]

PFS will be assessed from the first CEA-CAR-T cell infusion to death from any cause or the first assessment of progression.

Time frame

1 years

Overall survival(OS)of CEA- CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]

OS will be assessed from the first CEA-CAR-T cell infusion to death from any cause

Time frame

1 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weijia Fang, MD

Lead sponsor

Zhejiang University

Sponsor institution

Chongqing Precision Biotech Co., Ltd

Collaborator

Source ClinicalTrials.gov

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