Claudin18.2-redirected Chimeric Antigen Receptor T Cells With Co-expression of Cytokines in Solid Tumors

NCT05393986 | Unknown Phase 1

• 1 other identifier: CT048-CG4001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

An Open-Label, Single-Arm, Dose-Exploration Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of CT048 in Subjects with Advanced Solid Tumors

Conditions

Gastric Adenocarcinoma; Pancreatic Cancer; Gastroesophageal Junction Adenocarcinoma

Keywords

Claudin18.2; CAR-T cell therapy

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Safety

  28 days of single infusion

• Maximum tolerated dose

  Tolerability

  28 days of single infusion

Secondary Outcomes (7)

• Nature, incidence, severity and seriousness of TEAEs, TRAEs and AESI; graded according to the NCI-CTCAE (Version 5.0) or ASTCT

  1 year

• Pharmacokinetics(the number of CAR copies and CAR persistence duration in peripheral blood)

  1 year

• Antitumor efficacy-Overall response rate (ORR), Duration of response (DOR), Disease control rate (DCR)

  1 year

• Antitumor efficacy-Duration of response (DOR)

  1 year

• Antitumor efficacy-Disease control rate (DCR)

  1 year

Study Arms (1)

Experimental: CAR-CLDN18.2 T-Cells (CT048)

EXPERIMENTAL

The subjects will be initially enrolled in the lymphodepletion cohort. Subsequent subjects will be enrolled in the non-lymphodepletion cohort after reviewing the data in the lymphodepletion cohort.

Drug: CT048 Autologous Injection (CT048)

Interventions

CT048 Autologous Injection (CT048) DRUG

up to 3 times CT048 Autologous Injection infusion

Also known as: CT048 Autologous CAR T-cell Injection

Experimental: CAR-CLDN18.2 T-Cells (CT048)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years, male or female;
• Estimated life expectancy \> 12 weeks;
• Pathologically/histologically confirmed diagnosis of advanced G/GEJ adenocarcinoma or pancreatic cancer or other digestive system malignancies G/GEJA: refractory to or intolerable of at least 2 prior lines of treatment; HER2+ subjects must be refractory or intolerable of anti-HER2 treatment PC: refractory to or intolerable of at least 1 prior line of treatment;
• Positive expression of CLDN18.2 in tumor tissue specimens;
• According to the RECIST 1.1, there is measurable or unmeasurable tumor lesions;
• ECOG physical status score 0 \~ 1 at screening, within 24 hours prior to apheresis;
• Sufficient venous access for leukapheresis (central venous catheter)
• Subjects should have adequate organ functions before screening :
• Women of childbearing age (WOCB) be willing to use effective and reliable method of contraception (annual failure\<1%) for at least 1 year after last infusion, and must refrain from donating sperms/eggs
• Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy. Moreover, all men are absolutely forbidden to donate sperm within 1 year after receiving the last infusion.

You may not qualify if:

• High risks that may cause bleeding or perforation;
• CNS metastasis, with or without related symptoms;
• The presence of extensive lung metastases, or extensive liver metastases, or extensive bone metastases
• History or current unstable or active digestive ulcers, gastrointestinal (GI) bleeding, GI obstruction;
• Anti-tumor treatment for the investigational disease; treatment with anti-PD-1/PD-L1, anti-CTLA4, and any other immunotherapy or investigational therapy；
• Prior treatment with any genetically modified cell therapy;
• Treatment with systemic corticosteroids within 7 days prior to leukapheresis;
• Prior solid organ transplantation, or allogeneic stem cell, or in the waiting list for organ transplantation;
• Major surgical procedure or serious wound within 4 weeks prior to leukapheresis, or anticipation of need for a major surgical procedure during the study;
• Positive serological tests of HIV, syphilis or HCV (subjects with positive HCV antibody but are negative for HCV RNA are eligible);
• Any active or severe infection, incl. but not limited to active tuberculosis, HBV infection, etc.;
• Active autoimmune disease;
• Uncontrolled significant cardiovascular disease, pulmonary disease or CNS disease
• History of malignancy other than investigational diseases within 3 years, with the exception of malignancies with a negligible risk of metastasis or death;
• Pregnancy or lactating women;

Sponsors & Collaborators

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

Study Sites (1)

Beijing Cancer Hospital, Beijing, China

Beijing, 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

• Lin Shen, MD,phD

  Department of GI Oncology, Peking University Cancer Hospita

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lin Shen, MD,phD

CONTACT

861088196561; linshenpku@163.com

Changsong Qi, MD, PhD

CONTACT

861088196561; xiwangpku@126.com

Study Design

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

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 27, 2022
• Study Start: August 4, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)