Safety and feasibility of CD19 CAR-T cells in adults with recurrent and hard-to-treat B cell blood cancers

Phase 1

• Conditions: CD19-positive recurrent and refractory B cell malignancies; Cancer

• Registration Number: ISRCTN17901467
• Lead Sponsor: Siriraj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-27
• Last Update Posted: 6 May 2024
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

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
11. Patients who use systemic steroids within 2 weeks prior to treatment (except for inhaled steroids)
12. Patients with other uncontrolled diseases who are considered to be unsuitable to anticipate in the research by researchers
13. Any conditions that researchers believe may increase the risk to patient safety or may interfere with the overall outcome

Study & Design

• Study Type: Interventional
• Study Design: Not specified