Clinical Study of CAR-T Technology for the Treatment of Relapsed Refractory Malignant Haematological Tumours

Launched by SHANXI BETHUNE HOSPITAL · Jan 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CAR-T technology for patients with certain types of blood cancers that have not responded to previous treatments. The goal is to see how safe and effective this therapy is for individuals aged 14 to 70 who have been diagnosed with a malignant hematological tumor, which means their cancer is in the blood or bone marrow. To participate, patients need to have measurable cancer lesions and good overall health, including properly functioning organs.

Participants in the trial can expect to go through several stages: first, there will be a screening to see if they qualify; then, they will receive a special treatment to prepare their body for CAR-T therapy; after that, there will be short- and mid-term follow-ups to monitor their progress. It's important to know that not everyone can join; for example, those who are pregnant or have certain infections or serious health conditions may be excluded. If you or a loved one is considering this trial, it’s an opportunity to help researchers learn more about CAR-T therapy and its potential benefits for treating challenging blood cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. patients or their legal guardians voluntarily participate and sign an informed consent form;
• • 2. male or female patients aged 14 to 70 years (inclusive);
• • 3. be diagnosed as malignant haematological tumour by pathological and histological examination;
• • 4. have a measurable or evaluable lesion;
• 5. the patient has good function of major tissues and organs:
• • (1) Liver function: ALT/AST \<3 times upper limit of normal (ULN) and total bilirubin ≤34.2 μmol/L; (2) Renal function: creatinine \<220 μmol/L; (3) Lung function: room oxygen saturation ≥95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. (6) Patient's peripheral superficial venous blood flow is smooth and can meet the demand of intravenous drip; 7. patients with ECOG score ≤2 and expected survival time ≥3 months.
• Exclusion Criteria:
• • 1. Women who are pregnant (positive urine/blood pregnancy test) or breastfeeding;
• • 2. men or women who are planning to conceive within the last 1 year;
• • 3. patients who cannot guarantee effective contraception (condoms or birth control pills, etc.) within 1 year of enrolment;
• • 4. patients with uncontrolled infections within 4 weeks prior to enrolment;
• • 5. active viral hepatitis B/C;
• • 6. patients with HIV infection;
• • 7. patients with severe autoimmune diseases or immunodeficiency diseases;
• • 8. patients who are allergic to large molecule biopharmaceuticals such as antibodies or cytokines;
• • 9. patients who have participated in other clinical trials within 6 weeks prior to enrolment;
• • 10. the patient has used hormones systematically within 4 weeks prior to enrolment (except for patients using inhaled hormones);
• • 11. the patient has a psychiatric disorder
• • 12. the patient has substance abuse/addiction;
• • 13. other conditions that, in the judgement of the investigator, make the patient unsuitable for enrolment.