A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer

NCT05911217 | Recruiting Phase 1

• 1 other identifier: CT041-ST-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 8

Brief Summary

An open-label, single-arm, multicenter, Phase Ib clinical trial to evaluate the efficacy and safety of CT041 Autologous CAR T Cell Injection after adjuvant chemotherapy in subjects with pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

Adjuvant therapy; Pancreatic Cancer; Claudin18.2; CLDN18.2; CAR T cell

Outcome Measures

Primary Outcomes (1)

• Disease free survival (DFS)

  The time from the first infusion to the occurrence of local recurrence/distant metastasis or death from any cause, whichever occurred first.

  Up to 18 months

Secondary Outcomes (6)

• Incidence of Treatment Related adverse events (AEs), treatment related AEs, AEs of special interest (AESI).

  Up to 18 months

• 1 year DFS rate

  Up to 18 months

• Metastasis free Survival (MFS)

  Up to 18 months

• Overall Survival (OS)

  Up to 18 months

• The phamacokinetics in subjects receiving CT041 infusion in this study

  Up to 18 months

Study Arms (1)

anti-claudin18.2 chimeric antigen receptor T-cell therapy

EXPERIMENTAL

Experimental: anti-claudin18.2 chimeric antigen receptor T-cell therapy Phase 1b: Evaluate the efficacy and safety of CT041

Drug: CT041 autologous CAR T-cell injection

Interventions

CT041 autologous CAR T-cell injection DRUG

Treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion. Up to 3 times CT041 autologous CAR T-cell injection infusion

Also known as: Single Group Assignment

anti-claudin18.2 chimeric antigen receptor T-cell therapy

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in the clinical trial; fully understand, be informed about this study and have signed the ICF; willing to follow and able to complete all study procedures;
• Aged 18 to 79 years;
• Histologically confirmed pancreatic ductal adenocarcinoma;
• Macroscopic complete tumor removal (R0 or R1 resection);
• Postoperative pathological stage (pTNM): T1-3, N0-2, M0;
• Immunohistochemistry (IHC) staining of subject's tumor tissue sample is CLDN18.2-positive;
• Subjects had recovered from surgery and had received 3 months of standard adjuvant therapy;
• Abnormal CA19-9 level;
• With sufficient venous access for leukapheresis collection;
• ECOG performance status score 0-1;
• Adequate organ function;
• Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy;

You may not qualify if:

• Prior neoadjuvant therapy for pancreatic cancer;
• Subjects with borderline resectable pancreatic cancer;
• Present or past history of metastatic or locally recurrent pancreatic cancer;
• Evidence of malignant ascites;
• Subjects had diseases that may interfere with CA19-9 level, including but not limited to cholangitis, pancreatitis, obstructive jaundice, etc.
• Toxicities caused by previous treatment have not recovered to CTCAE ≤ grade 2, except alopecia and other tolerable events as judged by the investigator or laboratory abnormalities allowed in this study;
• Pregnant or lactating women;
• Positive serology for HIV, Treponema pallidum or HCV;
• Any active infections, including but not limited to active tuberculosis, HBV, EBV, CMV, COVID-19 infections;
• Clinically significant thyroid dysfunction;
• Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredients and other serious allergic history;
• Subjects who may be at high risk for potential digestive tract bleeding or perforation;
• Known active autoimmune disease, including but not limited to, psoriasis or rheumatoid arthritis, or other conditions requiring long-term immunosuppressive therapy;
• Subjects who have a history of organ transplantation or are awaiting organ transplantation;
• Subjects who require anticoagulant therapy;

Sponsors & Collaborators

• CARsgen Therapeutics Co., Ltd.: lead
• Fudan University: collaborator

Study Sites (8)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, China

RECRUITING

Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Fudan University Shanghai Cancer Hospital

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Xianjun Yu, Ph.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lifeng Zhang

CONTACT

86-21-54489928; lifengzhang@carsgen.com

Ning Wang

CONTACT

86-21-54489926; ningwang@carsgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 20, 2023
• Study Start: July 11, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)