Actively Recruiting
Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Colorectal Cancer
Led by Beijing Immunochina Medical Science & Technology Co., Ltd. · Updated on 2024-12-05
9
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
Sponsors
B
Beijing Immunochina Medical Science & Technology Co., Ltd.
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety and efficacy of IM96 CAR-T cells in treating patients with advanced colorectal cancer
CONDITIONS
Official Title
Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Diagnosed with advanced gastrointestinal tumors, mainly metastatic colorectal cancer, after failing or being intolerant to second-line or higher standard therapy
- Standardized systemic treatment received must follow the Chinese Society of Clinical Oncology (CSCO) Guidelines, 2024 Edition
- Intolerance to treatment includes inability to continue due to severe toxic side effects such as grade 3 or higher vomiting, diarrhea, abdominal pain, or bone marrow suppression
- At least one measurable lesion meeting RECIST 1.1 criteria
- Provide a tumor sample within 2 years testing positive for GUCY2C expression by immunohistochemistry
- Expected survival of more than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Women of childbearing potential must have a negative pregnancy test before the trial and agree to use effective contraception during the trial and until last follow-up; male patients with partners of childbearing potential must also agree to use effective contraception
- Laboratory tests meeting specified minimum values for hemoglobin, neutrophil count, platelet count, lymphocyte count and percentage, creatinine clearance, liver enzymes, bilirubin, albumin, prothrombin time, and normal heart and oxygen function
- Adequate vascular access for cell collection
- Voluntary participation and signed informed consent
You will not qualify if you...
- Presence of brain metastases
- Previous or pending organ transplant
- Unstable or unresolved toxicity from prior therapy above grade 1 (unless deemed clinically insignificant)
- Uncontrollable compression symptoms from plasmapheresis such as pleural, abdominal, or pericardial effusion
- Autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to screening
- Chronic obstructive pulmonary disease, interstitial lung disease, or significant lung function abnormalities
- Use of therapeutic corticosteroids within 7 days before cell collection (topical or inhaled steroids allowed)
- Chemotherapy within 1 week before cell collection (oral chemotherapy allowed if passed 3 half-lives)
- Use of bone marrow stimulating drugs within 5 days before cell collection
- Use of study drugs within 4 weeks before cell collection unless prior trial treatment was ineffective and 5 half-lives elapsed
- Recent interventional therapy, radiotherapy, ablation, or localized treatments within 4 weeks prior to cell collection
- Major surgery or trauma within 4 weeks prior to cell collection or expected during study
- Treatment with targeted agents like regorafenib or furaquintinib within 1 week prior to cell collection
- Prior anti-GUCY2C targeted therapy unless test remains positive
- Previous cell or genetically modified therapy such as TCR-T or CAR-T
- Immunotherapy like anti-PD1 or PD-L1 must be stopped for at least 5 half-lives before CAR-T infusion
- Significant central nervous system disorders or psychiatric conditions
- Chronic or active infections requiring systemic treatment or viral infections not fully cured
- Active Epstein-Barr virus or cytomegalovirus infection
- Live vaccination within 6 weeks before screening
- Significant cardiac abnormalities or recent severe cardiac events
- Need for anticoagulation therapy or long-term clotting-affecting medications
- Recent symptomatic deep vein thrombosis or pulmonary embolism
- Other untreated or concurrent cancers except specific in situ or basal cell carcinomas
- Infections requiring intravenous antimicrobials or uncontrolled infections
- Digestive tract obstruction or high risk for bleeding or perforation
- Concurrent enrollment in another interventional clinical study
- Any factors affecting ability or willingness to comply with the study protocol as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
F
Fei Wu
CONTACT
L
Lin Shen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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