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

NCT ID: NCT03598179

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-07-01

Brief Summary

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

Conditions

Lymphoma, B-Cell; Leukemia, B-cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

chimeric antigen receptor T cells

Dose CAR+ cells/kg B-cell lymphoma 4×10\^6 Acute lymphocytic leukemia 2×10\^6 Chronic lymphocytic leukemia 10×10\^6

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

JianYong Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Nanjin, Jiangsu, China

Countries

China

References

Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

Reference Type: DERIVED

PMID: 34515338 (View on PubMed)

Other Identifiers

JSPH-CART001

Identifier Type: -

Identifier Source: org_study_id