Phase 1 / Phase 2: testing Autologous CAR-T cell injection targeting EpCAM for Epithelial Cancer Patients
This is an open -label phase I /IIa study designed to measure the safety and how well it works of IMC001 in patients with advanced epithelial solid tumors. The study comprises two parts: a phase I dose-escalation phase and a phase IIa phase to further explore and validate how well it works .In the Phase I dose-escalation phase of this study, approximately 7-15 subjects with advanced epithelial solid tumors will be recruited to measure the whether it is safe and how hard side effects are to live with of autologous IMC001 treatment .
Official registry: https://clinicaltrials.gov/study/NCT07644403 · Suzhou Immunofoco Biotechnology Co., Ltd · enrollment listed as 30
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Autologous CAR-T cell injection targeting EpCAM. The registry lists allocation as na. This is an open -label phase I /IIa study designed to measure the safety and how well it works of IMC001 in patients with advanced epithelial solid tumors.
They plan to enroll about 30 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of IMC001 in Patients With Advanced Epithelial Solid Tumors.
Interventions: Autologous CAR-T cell injection targeting EpCAM
Primary outcome (registry wording): Observe dose limiting toxicity (DLTs) of IMC001 within 28 days after administration according to the DLT definition in the protocol
Who it is for (from inclusion criteria)
- Ages 18 Years to 75 Years
- Applicants must be 18 years of age or older and 75 years of age or younger; both male and female applicants are welcome
- Disease progression or intolerance to standard systemic therapy , including:
- Other subjects with epithelial solid tumors who have failed or are intolerant of standard treatment
- Tumor tissue samples (primary or metastatic, archived or newly collected) from the expected subjects, tested by the central laboratory, are EpCAM histologically positive (defined as tumor cell positivity ≥10% and staining intensity ≥1+)
- The expected survival period of the subjects is ≥12 weeks
- According to RECIST 1.1 criteria, there should be at least one stably measurable target lesion (where the largest lesion should be ≤4). In the 3×10⁵ CAR -T cells/kg dose group, subjects with evaluable lesions (unmeasurable lesions) can be admitted
- how well you can do daily activities (ECOG score) score 0-1
Who the registry excludes
- Pregnant and breastfeeding women
- Severe infections that are in an active phase or poorly controlled clinically
- The patients had uncontrollable pleural effusion, pericardial effusion, and ascites before enrollment
- Extensive or diffuse lung metastases , extensive or diffuse liver metastases , extensive or diffuse bone metastases
- Subjects with intestinal obstruction or obstructive jaundice who are deemed unsuitable for participation in this trial by the researchers
- Blood oxygen saturation ≤95% without oxygen supplementation
- Central nervous system metastasis or meningeal metastasis
Public study contact (from the registry)
Lin Shen, PhD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Beijing Cancer Hospital — Beijing, China (recruiting)
FAQ about this NCT record
Is NCT07644403 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07644403?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07644403?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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