Description:
A Phase 1b, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells
(CAR-T) targeting claudin18.2 in patients with advanced gastric or pancreatic adenocarcinoma
Title
- Brief Title: Claudin18.2 CAR-T (CT041) in Patients With Gastric or Pancreatic Cancer
- Official Title: Open-label, Multicenter, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of Autologous Claudin 18.2 Chimeric Antigen Receptor T-cell Therapy in Patients With Advanced Gastric or Pancreatic Adenocarcinoma
Clinical Trial IDs
- ORG STUDY ID:
CT041-ST-02
- NCT ID:
NCT04404595
Conditions
- Gastric Cancer
- Pancreatic Cancer
Interventions
Drug | Synonyms | Arms |
---|
CT041 | | anti-claudin18.2 chimeric antigen receptor T-cell therapy |
Purpose
A Phase 1b, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells
(CAR-T) targeting claudin18.2 in patients with advanced gastric or pancreatic adenocarcinoma
Detailed Description
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.
Part A of the study will be Dose Escalation followed by Part B, an expansion cohort.
Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. Patients
meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous
mononuclear cells for manufacture of investigational drug product (CT041). Following
manufacture of the drug product, subjects will receive preconditioning prior to CT041
infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.
Trial Arms
Name | Type | Description | Interventions |
---|
anti-claudin18.2 chimeric antigen receptor T-cell therapy | Experimental | Phase 1 will include two parts, a dose escalation part to determine the recommended dose for the expansion part. During expansion patients will be treated with the recommended dose determined in the expansion part. | |
Eligibility Criteria
Inclusion Criteria:
Patients are eligible for screening for potential inclusion in the study:
1. Voluntarily signed the ICF;
2. Age ≥ 18 and ≤ 80 years with pathologically/histologically confirmed diagnosis of
adenocarcinoma of the stomach or gastroesophageal junction, referred to collectively
as STAD, or pancreatic adenocarcinoma (PAAD);
3. Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay;
4. Age ≥ 18 and ≤ 80 years with pathologically/histologically confirmed diagnosis of
STAD, or PAAD who have failed or been intolerant of prior lines of systemic therapy;
5. Estimated life expectancy > 12 weeks;
6. At least 1 measurable lesion per RECIST 1.1;
7. ECOG performance status of 0 or 1;
8. Sufficient venous access for leukapheresis collection and no other contraindications
to leukapheresis;
9. Patients should have reasonable CBC counts, renal and hepatic functions;
10. 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;
11. Men must be willing to use effective and reliable method of contraception for at least
6 months after T-cell infusion;
Exclusion Criteria:
1. Pregnant or lactating women;
2. HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infusion;
3. Any uncontrolled active infection;
4. AEs from previous treatment that have not recovered;
5. Patients who have clinically significant thyroid dysfunction;
6. Patients allergic to any drugs of the preconditioning regimen, tocilizumab, dimethyl
sulfoxide (DMSO), or CT041 CAR-CLDN18.2 T-cell;
7. 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;
8. Patients with heavy tumor burden such as significant lung disease
9. Unstable/active ulcer or digestive tract bleeding or recent digestive surgery that may
have increased risk of bleeding;
10. Patients who have a history of esophageal or gastric resection with increased risk of
bleeding or perforation;
11. Patients requiring anticoagulant therapy such as warfarin or heparin;
12. Patients requiring long-term antiplatelet therapy;
13. Use of prednisone or other equivalent within 14 days before leukapheresis or
preconditioning;
14. Anticancer treatment within approximately 2 weeks prior to leukapheresis or
approximately 3 weeks before preconditioning;
15. Major surgery less than 1 week prior to leukapheresis or 3 weeks prior to
preconditioning;
16. Patients have clinical significant cardiac conditions that researchers believe that
participating in this clinical trial may endanger the health of the patients;
17. Patients have clinical significant pulmonary conditions;
18. Patients known to have active autoimmune diseases;
19. Patients with second malignancies in addition to STAD or PAAD;
20. Patients have significant neurologic disorders;
21. Patients are unable or unwilling to comply with the requirements of clinical trial.
Maximum Eligible Age: | 80 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of Treatment Related adverse events (AEs) |
Time Frame: | day 1 - month 12 |
Safety Issue: | |
Description: | Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs) |
Secondary Outcome Measures
Measure: | Time to Progression |
Time Frame: | day 1 - month 12 |
Safety Issue: | |
Description: | Duration of time from CT041 treatment to progression of disease |
Measure: | Duration of Response |
Time Frame: | day 1 - month 12 |
Safety Issue: | |
Description: | Duration of time from first response to progression of disease |
Measure: | Disease Control Rate |
Time Frame: | day 1 - month 12 |
Safety Issue: | |
Description: | Percentage of patients response at least 90 days |
Measure: | Progression free survival |
Time Frame: | day 1 - month 12 |
Safety Issue: | |
Description: | duration time after CT041 treatment that patient lives without worsening of disease |
Measure: | Overall survival |
Time Frame: | day 1 - month 12 |
Safety Issue: | |
Description: | duration time after CT041 treatment that patient lives |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Carsgen Therapeutics, Ltd. |
Trial Keywords
Last Updated
August 3, 2021