Actively Recruiting
Clinical Trial for the Safety and Efficacy of CAR-T Cells Therapy for Patients With the Central Nervous System Involvement of Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia or B-cell Non-Hodgkin's Lymphoma
Led by Zhejiang University · Updated on 2020-10-26
72
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CAR-T cell therapy in patients with relapsed or refractory central nervous system CD19-positive B-cell hematological cancers. These include acute lymphoblastic leukemia and B-cell non-Hodgkin's lymphoma. This single-center, open-label, early-phase study aims primarily to explore the safety of this therapy with a focus on dose-related safety aspects. Participants will receive CAR-T cells by intravenous infusion following a dose-escalation design with three dose levels. Two groups of 36 patients each will be enrolled. The study also involves surgical placement of an Ommaya reservoir catheter into the brain's fourth ventricle to assist treatment delivery. Dose escalation follows a standard 3+3 model. During the study, participants will be monitored for dose-limiting toxicity up to 28 days after infusion and for treatment-emergent adverse events up to two years. Researchers will assess response rates, overall survival, event-free survival, disease control, and quality of life using various clinical and psychological scales over periods up to two years. The total participation time can extend to two years with multiple evaluations and safety monitoring.
CONDITIONS
Brief Title
A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 3 to 70 years for B-ALL or 18 to 75 years for B-NHL
- Histologically confirmed diagnosis of B-cell acute lymphoblastic leukemia or B-cell non-Hodgkin's lymphoma
- Relapsed or refractory CD19-positive B-ALL or B-NHL meeting specific treatment response criteria
- Highly suspected or confirmed central nervous system involvement of hematological malignancies
- Adequate liver and kidney function with total bilirubin ≤ 51 umol/L and creatinine ≤ 176.8 umol/L
- Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram
- No active lung infection and blood oxygen saturation ≥ 92% in indoor air
- Estimated survival time of at least 3 months
- ECOG performance status between 0 and 2
- Patients or their legal guardians agree to participate and sign informed consent
You will not qualify if you...
- History of brain trauma, consciousness disorders, epilepsy, cerebrovascular ischemia, or hemorrhagic diseases
- Prolonged QT interval or severe heart diseases like severe arrhythmia
- Pregnant or breastfeeding women
- Severe active infections excluding simple urinary tract infection or bacterial pharyngitis
- Active hepatitis B or C infection
- Systemic steroid therapy within 2 weeks before screening except inhaled steroids
- Previous treatment with any CAR-T cell or genetically modified T cell therapy
- Elevated creatinine (>2.5 mg/dl), ALT/AST (>3 times normal), or bilirubin (>2.0 mg/dl)
- Other uncontrolled diseases unsuitable for the trial
- HIV infection
- Any condition increasing risk or interfering with study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo placement of a surgical catheter (Ommaya Reservoir) into the fourth ventricle of the brain.
1 visit (in-person)
Duration - Up to 28 days after CAR T-cells infusion
Participants receive CAR T-cells by intravenous infusion as part of dose escalation following a 3+3 design with 3 dose levels.
1 infusion visit and follow-up visits during 28 days
Duration - Up to 2 years
Participants are monitored for safety, efficacy, and quality of life for up to 2 years after CAR T-cells infusion.
Regular visits at Month 1, 3, 6, 9, 12, 18, and 24 for assessments
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital，College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, PhD
Y
Yongxian Hu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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