Status:
UNKNOWN
Claudin18.2-redirected Chimeric Antigen Receptor T Cells With Co-expression of Cytokines in Solid Tumors
Lead Sponsor:
Peking University
Collaborating Sponsors:
CARsgen Therapeutics Co., Ltd.
Conditions:
Gastric Adenocarcinoma
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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
Detailed Description
This is an open-label, single-arm, dose-escalation and dose-expansion, single/multiple infusion(s) exploratory study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of CT048 in pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- History of allergic anaphylactic reactions to immunotherapy, and/or tocilizumab, cyclophosphamide, fludarabine or nab-paclitaxel, and/or CT048 components, or other history of severe allergic anaphylactic reactions ；
- Blood oxygen saturation ≤95% before leukapheresis;
- AEs from previous treatment that have not recovered to CTCAE ≤ grade 1, excluding hair loss, pigmentation, and other tolerable events and laboratory abnormalities permitted by the protocol;
Key Trial Info
Start Date :
August 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05393986
Start Date
August 4 2022
End Date
December 30 2024
Last Update
May 31 2023
Active Locations (1)
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1
Beijing Cancer Hospital, Beijing, China
Beijing, China