XLCART001 Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects

Nanjing Medical University

Status and phase: Unknown; Phase 2

Conditions: Leukemia, B-cell; Lymphoma, B-Cell

Treatments: Biological: chimeric antigen receptor T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03598179

JSPH-CART001

Details and patient eligibility

About

The trial is a single arm, single-center, non-randomized clinical trial which is designed to evaluate the efficacy and safety of XLCART001 in treatment of relapsed/refractory/high-risk B-cell malignancy subjects

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years, male and female,

• Confirmed as CD19-positive B cell lymphoma/leukemia by immunohistochemistry or flow cytometry

• No effective treatment

• Patients must have a measurable or evaluable disease at the time of enrollment.

• Adequate organ system function including:

  • ALT/AST < 3 upper limit of normal; Total Bilirubin < 2.5 upper limit of normal
  • Creatinine < 2 upper limit of normal
  • Oxygen saturation ≥ 95%
  • Left ventricular ejection fraction ≥ 40%
  • Number of neutrophil ≥ 0.75×10^9/L, number of platelet ≥ 50×10^9/L

• At least 4 weeks from receiving previous treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments)

• No contraindications of peripheral blood apheresis

• Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures

• ECOG score 0-2, expected survival ≥ 12 weeks

Exclusion criteria

• Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
• Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons
• Subjects with any autoimmune disease or any immune deficiency disease
• Have a history of allergy to antibodies or cellular products
• Participated in any other clinical trial within four weeks
• Used of systemic steroids within four weeks (using inhaled steroids or ≤ 20mg/d prednison are exceptions)
• Have mental diseases
• Have history of drug addiction
• The investigators believe that any increase in the risk of the subject or interference with the results of the trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)