ISRCTN17901467
Active, not recruiting
Phase 1
A pilot study: evaluation of efficacy and safety of autologous or graft HLA-matched donor-derived CD19 CAR-T cells for the treatment of CD19-positive recurrent and refractory B cell malignancies in adults
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Siriraj Hospital
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult patients with CD19\-positive recurrent and refractory B cell malignancies, aged 18\-70 years old
- •2\. Karnofsky Performance Status (KPS) score \=60, expected survival \=3 months
- •3\. Platelet count (PLT) \=30 × 10^9/L
- •4\. Lymphocyte count (LYM) \=0\.15 × 10^9/L
- •5\. Serum alanine aminotransferase (ALT) \=100 U/mL
- •6\. Total bilirubin (T\-BIL) \=30 µmol/L
- •7\. Creatinine \=200 µmol/L
- •8\. Women of childbearing age are negative for the urine pregnancy test before the start of dosing and agree to take effective contraceptive measures
- •9\. Voluntary participation, good compliance: willing to take part in studies and cooperate with clinical observations and follow\-up plan
Exclusion Criteria
- •1\. Clinically diagnosed as central nervous system leukemia
- •2\. Patients with hyperleukocytosis (WBC \=50 × 10^9/L), or the researcher judges that the patient cannot receive a complete treatment cycle due to his rapid disease progress
- •3\. Patients with fungi, bacteria, viruses or other uncontrolled infections or requiring isolation
- •4\. Patients with positive HIV, HBV, and HCV
- •5\. Patients with central nervous system diseases such as stroke, epilepsy, dementia or autoimmune neurological disorders
- •6\. Patients with myocardial infection, cardiac angiography or stent, active angina or other obvious clinical symptoms, or with cardiac asthma or cardiovascular lymphocytic infiltration within 12 months prior to enrollment
- •7\. Patients who are receiving anticoagulant therapy or who have severe coagulation disorders (aPTT \>70\)
- •8\. Patients who receive medication that may affect the safety and efficacy of CAR\-T cell product
- •9\. Patients with a history of allergies to the biologics used in this project
- •10\. Pregnant or lactating women
Outcomes
Primary Outcomes
Not specified
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