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New treatment option for Colorectal Cancer (CRC)
Official title Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Colorectal Cancer
ClinicalTrials.gov ID: NCT06718738
What this study is testing
What is IM96 CAR-T Cells?
IM96 CAR-T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer (crc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The age is 18 to 75 years (including boundary values) and the gender is not limited;
- Patients with advanced GI tumors diagnosed by pathohistology, mainly: (1)Patients with metastatic colorectal cancer who have failed or are intolerant...
- The standardized systemic treatment received by the patient must be in accordance with the Chinese Society of Clinical Oncology (CSCO) Guidelines for...
- Claims of treatment intolerance: Patients who are unable to continue current effective systemic standardized treatment due to toxic side effects such...
- Hemoglobin (Hb) ≥ 90 g/L;
You likely can't join if
- Presence of brain metastases;
- Patients who have previously received or are awaiting an organ transplant;
- Toxicity due to prior therapy not stabilized or recovered to ≤ grade 1 (except in cases judged by the investigator to be not clinically significant);
- Plasmapheresis (e.g., pleural effusion, abdominal effusion, pericardial effusion) with symptoms of compression that cannot be controlled with...
- Autoimmune disease requiring systemic immunosuppressive therapy (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) within 2 years prior to...
- Presence of chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), and clinically significant pulmonary function test...
See the full eligibility criteria
Who can join
- The age is 18 to 75 years (including boundary values) and the gender is not limited;
- Patients with advanced GI tumors diagnosed by pathohistology, mainly: (1)Patients with metastatic colorectal cancer who have failed or are intolerant to second-line and above standard therapy; Notes:
- The standardized systemic treatment received by the patient must be in accordance with the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Treatment of Colorectal and Gastric Cancer, 2024 Edition;
- Claims of treatment intolerance: Patients who are unable to continue current effective systemic standardized treatment due to toxic side effects such as grade ≥3 vomiting, diarrhea, abdominal pain, bone marrow...
- Hemoglobin (Hb) ≥ 90 g/L;
- Neutrophil count (Absolute neutrophil count, ANC) ≥ 1.5 x 10\^9/L;
- Platelet count (PLT) ≥ 75 x 10\^9/L;
- Absolute lymphocyte value ≥ 0.6 x 10\^9/L;
- Lymphocytes make up ≥10% of white blood cells;
- Creatinine clearance ≥60 ml/min;
- Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 x ULN and total bilirubin (TBL) ≤ 1.5 x ULN (for elevations of ALT and AST that can be explained by hepatic aggression, the high limits for AST and...
- Serum albumin ≥ 3.0 g/dL.
- Prolongation of prothrombinogen time ≤ 4s; 9.Left ventricular ejection fraction ≥ 50% with a normal ECG or an abnormal ECG that, in the judgment of the investigator, does not require treatment; 10.Oxygen saturation...
What rules you out
- Presence of brain metastases;
- Patients who have previously received or are awaiting an organ transplant;
- Toxicity due to prior therapy not stabilized or recovered to ≤ grade 1 (except in cases judged by the investigator to be not clinically significant);
- Plasmapheresis (e.g., pleural effusion, abdominal effusion, pericardial effusion) with symptoms of compression that cannot be controlled with treatment;
- Autoimmune disease requiring systemic immunosuppressive therapy (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) within 2 years prior to the start of screening;
- Presence of chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), and clinically significant pulmonary function test abnormalities;
- Use of any of the following medications or treatments during the designated time period prior to cell collection:
- Therapeutic doses of corticosteroids have been used within 7 days prior to cell collection. However, topical and inhaled steroids are permitted;
- Received chemotherapeutic agents within 1 week prior to cell collection. Enrollment was allowed if the oral chemotherapeutic drug had passed at least 3 half-lives prior to cell collection;
- Those who used drugs to stimulate bone marrow hematopoietic cell production within 5 days prior to cell collection;
- Use of study drug within 4 weeks prior to cell collection. However, enrollment was allowed if the trial treatment was ineffective or the disease progressed during the trial and at least 5 half-lives had elapsed prior to...
- Received treatment therapy, radiotherapy, ablation, and other localized treatments for the study disease within 4 weeks prior to cell collection;
- Patients who have had major surgery or significant trauma within 4 weeks prior to cell collection or who are expected to require major surgery during the study period;
- Received treatment with targeted agents such as regorafenib, furaquintinib, etc. within 1 week prior to cell collection;
- Prior treatment with anti-GUCY2C target (unless GUCY2C target test remains positive);
- Those who have received other cell therapy or genetically modified cell therapy in the past, such as TCR-T therapy, CAR-T therapy, etc;
- If immunotherapy such as anti-PD1 and PD-L1 has been used prior to IM96 CAR-T cell transfusion, at least 5 half-lives must have elapsed after the last dose and before IM96 CAR-T cell transfusion;
- Prior or clinically significant CNS disorders at screening, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia/hemorrhage/cerebral infarction), cerebral edema, reversible posterior...
- Chronic or active infection requiring systemic therapy and history of symptomatic viral infection that has not been completely cured. For example, Hepatitis B: patients who are positive for Hepatitis B surface antigen...
- Active EBV and cytomegalovirus, defined as patients with IgM antibody-positive or IgM antibody-negative but higher-than-normal EBV-DNA in EBV serum; and cytomegalovirus (CMV) seropositive or IgM antibody-negative but...
- Vaccination with live vaccine within 6 weeks prior to the start of screening;
- Abnormalities of cardiac function include: long QTc syndrome or QTc interval \>480 ms; complete left bundle branch block, degree II/III AV block; severe, uncontrolled arrhythmias requiring pharmacologic therapy; history...
- Patients requiring anticoagulation therapy;
- Requires long-term use of medications that can affect clotting (e.g., aspirin, warfarin, etc.);
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to initiation of screening;
- Other untreated malignant tumors within the previous 5 years or concurrently, except cervical cancer in situ, basal cell carcinoma of the skin, and ductal carcinoma in situ of the breast;
- Infections (fungal, bacterial, viral, or other) that require intravenous antimicrobial control or are uncontrollable, for simple urinary tract infections, and for bacterial pharyngitis, may be enrolled if the...
- Patients with digestive tract obstruction;
- Patients at high risk for bleeding or perforation;
- Concurrent enrollment in another clinical study, unless it is an observational (non-treatment) clinical study; The presence of any factors affecting compliance with the protocol or the patient's unwillingness or...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.