Clinical trial

CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

Name

UnicarTherapy

Description

This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.

Trial arms

Trial start

2017-03-01

Estimated PCD

2024-12-31

Trial end

2025-12-31

Status

Recruiting

Phase

Early phase I

Treatment

CD19 CAR-T cells

CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

Arms:

Arm 1

Size

Primary endpoint

The complete remission (CR) rate

Participants will be followed for the duration of the treatment, an expected average of 12 months

Eligibility criteria

Inclusion Criteria: 1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia 2. ALT/ AST 《 3x normal 3. Creatinine 《 3x normal 4. Age:10-60. 5. Signed informed consent Exclusion Criteria: 1. Active hepatitis B , hepatitis C or HIV infection 2. Uncontrolled active infection 3. Pregnancy or breast-feeding women 4. Survival less than four weeks

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

Updated at

2023-11-29

1 organization

2 products

3 indications

Organization

Shanghai Unicar-Therapy Bio-medicine Technology

Product

Indication

Indication

Product

Indication