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Clinical Trial 20760

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT04404595

Phase: Phase I
Principal Investigator: Kim, Dae Won

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

Open-Label, Multicenter, Phase 1b /2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous Anti-claudin18.2 Chimeric Antigen Receptor T-cell Therapy in Subjects with Advanced Gastric, Pancreatic, or Other Specified Digestive System Cancers

Summary

This is an open label, multi-center, Phase 1b clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in patients with advanced gastric or pancreatic adenocarcinoma.

Objective

Cohort A Primary -Evaluate the safety and tolerability of CAR-CLDN18.2 T-cell therapy (CT041) in patients with advanced STAD or PAAD -Identify the MTD and a RP2D of CT041 therapy in patients with STAD or PAAD Secondary: -Evaluate clinical efficacy outcomes with CAR-CLDN18.2 T-cell therapy (CT041) in patients with advanced STAD or PAAD Exploratory: -Evaluate PK and biodistribution of CAR-CLDN18.2 T-cell therapy (CT041) in patients with STAD or PAAD -Evaluate the performance of CLDN18.2 IHC assay in patients with STAD or PAAD -Evaluate anti-CAR-CLDN18.2 T-cell therapy (CT041) drug antibodies in patients with STAD or PAAD Cohort B Primary: -Determine the efficacy of CAR-CLDN18.2 T-cell therapy (CT041), in terms of ORR in patients with PAAD Secondary -Evaluate the safety and tolerability of CAR-CLDN18.2 T-cell therapy (CT041) in patients with PAAD -Evaluate additional clinical efficacy outcomes with CAR-CLDN18.2 T-cell therapy (CT041) in patients with PAAD Exploratory -Evaluate PK and biodistribution of CAR-CLDN18.2 T-cell therapy (CT041) in patients with PAAD -Evaluate the performance of CLDN18.2 IHC assay in patients with PAAD -Evaluate anti-CAR-CLDN18.2 T-cell therapy (CT041) drug antibodies in patients with PAAD

Treatments

Therapies

Cell Therapy

Medications

CT041 (); Nab-paclitaxel (Abraxane); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

Voluntarily signed the ICF

Age >18 and > Cohort A and B: Patients with STAD, PAAD or BTC

Cohort C: Patients with STAD

Must have CLDN18.2-positive tumor expression from a tumor sample collected > Life expectancy > 4 months

Must have prior lines of therapy defined by protocol

At least 1 measurable lesion per RECIST 1.1

ECOG performance status of 0 or 1

Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis

Patients should have reasonable CBC counts, renal and hepatic functions

Women of childbearing age must undergo a serum pregnancy test with negative results before screening and infusion and be willing to use effective and reliable method of contraception for at least 12 months after T-cell infusion.

Men must be willing to use effective and reliable method of contraception for at least 12 months after T-cell infusion

Sufficient nutritional status: Must must weigh >/= 38kg and females must weight >/= 34 kg. Patients must have > Additional criteria will apply

Exclusion Criteria

Pregnant or lactating women

HIV, active hepatitis C virus (HCV), active hepatitis B virus (HBV) or active syphilis infection. History of treated hepatitis B or C is permitted if the viral load is undetectable per qPCR and/or nucleic acid testing.

Any uncontrolled active infection

AEs from previous treatment that have not recovered

Patients who have clinically significant thyroid dysfunction

Patients allergic to any drugs of the preconditioning regimen, tocilizumab, dimethyl sulfoxide (DMSO), or CT041 CAR-CLDN18.2 T-cell

Patients who have received prior cellular therapy such as (CAR T, TCR, tumor-infiltrating lymphocytes) or organ transplantation; Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression

Patients with heavy tumor burden such as significant lung disease

Unstable/active ulcer or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding

Patients who have a history of esophageal or gastric resection with increased risk of bleeding or perforation

Patients requiring anticoagulant therapy such as warfarin or heparin

Patients requiring long-term antiplatelet therapy

Use of prednisone or other equivalent within 14 days before leukapheresis or preconditioning

Anticancer treatment within approximately 2 weeks prior to leukapheresis or approximately 3 weeks before preconditioning

Major surgery less than 1 week prior to leukapheresis or 3 weeks prior to preconditioning

Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients

Patients have clinical significant pulmonary conditions

Patients known to have active autoimmune diseases

Patients with second malignancies in addition to STAD or PAAD

Patients have significant neurologic disorders

Patients are unable or unwilling to comply with the requirements of clinical trial.

Additional criteria will apply

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