Status:
ACTIVE_NOT_RECRUITING
Claudin18.2 CAR-T (CT041) in Patients with Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers
Lead Sponsor:
CARsgen Therapeutics Co., Ltd.
Conditions:
Gastric Cancer
Pancreatic Cancer
Eligibility:
All Genders
18-76 years
Phase:
PHASE1
PHASE2
Brief Summary
A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive sys...
Detailed Description
This is an open label, multi-center, Phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in patients with advanced gastric,...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients are eligible for screening for potential inclusion in the study (\* indicates inclusion criteria at Baseline (for subjects to be eligible for preconditioning)):
- Voluntarily signed the ICF;
- Age ≥ 18 and \< 76 years with pathologically/histologically confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction, referred to collectively as STAD, or pancreatic adenocarcinoma (PAAD);or biliary tract cancers (BTCs, including intrahepatic/extrahepatic cholangiocarcinoma and gallbladder cancer but not ampullary carcinoma);
- Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay;
- Estimated life expectancy \> 4 months\*;
- Failed or been intolerant of prior lines of systemic therapy:
- For screening:
- Leukapheresis can be performed for subjects with STAD who have progressed or were intolerant of at least 1 prior line of systemic therapy, or,
- Leukapheresis can be performed for subjects with PAAD who are receiving first-line treatment, or,
- Leukapheresis can be performed for subjects with BTC who are receiving first-line treatment.
- Baseline\*:
- Subjects with STAD who have progressed or were intolerant of at least 2 prior lines of systemic therapy, or,
- Subjects with PAAD who have progressed or were intolerant of at least 1 prior line of systemic therapy, or,
- Subjects with BTC who have progressed or were intolerant of at least 1 prior line of systemic therapy. For subjects with CCA with who has FGFR2 fusions or rearrangements, or IDH1-mutant must have received FDA-approved target therapies.
- 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 adequate 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\*;
- Men must be willing to use effective and reliable method of contraception for at least 12-months after T-cell infusion\*;
- Sufficient nutritional status.
- Exclusion Criteria for screening (\* indicates exclusion criteria for baseline as well):
- Pregnant or lactating women\*;
- HIV, active hepatitis C virus (HCV), active hepatitis B virus (HBV), or active syphilis infection;
- Any active infection requiring systemic treatment\*;
- 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) within one year.
- organ transplantation.
- previous anti-claudin18.2 CAR T-cell therapy, mRNA-based cancer immunotherapy, or bispecific T cell engager.
- Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression;
- Patients with heavy tumor burdens;
- Unstable/active ulcer, anastomotic recurrence with full-thickness tumor infiltration or tumor involving any major vessels, digestive tract bleeding, or recent digestive surgery that may have increased risk of bleeding\*;
- Patients who have a history of esophageal or gastric resection plus current evidence of locally recurrent tumor that involves any major blood vessels or that has evidence of recent bleeding or perforation\*;
- Patients requiring anticoagulant therapy such as warfarin or heparin;
- Patients requiring long-term antiplatelet therapy;
- Use of prednisone \>/= 10mg daily or other equivalent steroids within 14 days before leukapheresis or preconditioning\*;
- Anticancer treatment within approximately 2 weeks prior to leukapheresis or preconditioning\*;
- Major surgery less than 1 week prior to leukapheresis or 3 weeks prior to preconditioning\*;
- Patients who have clinically significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients\*;
- Inadequate pulmonary function\*;
- Patients known to have active autoimmune diseases;
- Patients with second malignancies;
- Patients have significant neurologic disorders;
- Patients are unable or unwilling to comply with the requirements of clinical trial.
- Additional exclusion criteria solely for baseline (prior to conditioning regimen):
- Fever \> 38.0°C;
- Active illness or existing toxicity that would place the subject at undue risk;
- Abrupt deterioration of clinical status or condition;
- Subjects who have received a live attenuated vaccine 4 weeks before preconditioning.
- Inclusion Criteria Before Infusion: There are no inclusion criteria at this timepoint.
- Exclusion Criteria Before Infusion:
- Patients who have clinically significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
- Inadequate pulmonary function;
- Active infection requiring systemic therapy or causing fever within 7 days prior to investigational infusion;
- Active illness or toxicity that would place the subject at undue risk;
- Abrupt deterioration of clinical status or condition;
- New or worsening Grade ≥ 3 non-hematologic toxicities.
Exclusion
Key Trial Info
Start Date :
October 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2035
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04404595
Start Date
October 23 2020
End Date
September 1 2035
Last Update
January 8 2025
Active Locations (16)
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1
City of Hope
Duarte, California, United States, 91010
2
University of Southern California
Los Angeles, California, United States, 90089
3
UCSD
San Diego, California, United States, 92093
4
UCSF
San Francisco, California, United States, 94143