Umbilical Cord Blood Derived MAK Immune Cells Combined With Standard Second-Line Treatments for H… (NCT05240690) | Clinical Trial Compass
UnknownPhase 1
Umbilical Cord Blood Derived MAK Immune Cells Combined With Standard Second-Line Treatments for Hepatobiliary and Pancreatic Malignancies
China27 participantsStarted 2022-02-07
Plain-language summary
To evaluate the safety of MAK immune cells derived from umbilical cord blood combined with second-line treatments for hepatobiliary and pancreatic malignancies.And to investigate the initial efficacy of MAK immune cells derived from umbilical cord blood combined with second-line treatments for hepatobiliary and pancreatic malignancies.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age over 18 years old, under 75 years old, men and women;
✓. Subjects participated voluntarily, gave full informed consent, signed a written informed consent, with good compliance;
✓. Hepatocytic carcinoma or biliary or pancreatic-derived adenocarcinoma was clearly diagnosed by histological or cytology pathology;
✓. Recurrent hepatobiliary or pancreatic malignancies with unresectable advanced or metastatic, or postoperative adjuvant therapy (chemotherapy and / or radiation therapy) for 12 months, with a Child-Pugh score of 7;
✓. With 1 measurable lesion, according to the RECIST v 1.1 criteria.Requirements: The selected target lesion has not previously received local treatment, or the selected target lesion was located in the previous local treatment area after passing the imaging examination and was determined as PD according to the RECIST v 1.1 criteria;
✓. ECOG score of 0-1;
✓. Expected survival is greater than 3 months;
✓. Main organ function composite with the following requirements:
Exclusion criteria
✕. At the same time, there are serious medical diseases, including serious heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, uncontrolled infection, active digestive tract ulcer;
✕. Patients with brain metastasis with clinical symptoms;
. Suffering from other primary malignancies in the past 5 years (except skin BCC or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled);
✕. Patients with immunodeficiency or autoimmune diseases (e. g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, insulin-dependent diabetes, etc.).
✕. Patients who participated in other clinical trials or clinical study treatment within the 3 months prior to this clinical study.
✕. Patients treated with other cells within the last 6 months.
✕. Patients with infection and fever who were not effectively controlled.
✕. Patients with high allergies or a history of severe allergies.