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

Lymphoma, B-Cell Clinical Trial

Official title:

A Single-center, Open Study Evaluating Efficacy and Safety of XLCART001（CD-19） Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03598179
• Other study ID #: JSPH-CART001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2019
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: July 1, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia, B-cell
• Lymphoma, B-Cell

Intervention

Biological:
• 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

Locations

Country	Name	City	State
China	Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital	Nanjin	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 12.	12 weeks
Primary	Overall Survival	from the time of enrollment to death from any cause or the date of the last follow-up visit	6 months,1 year, 2 years
Primary	Progression-free Survival	the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit	12 weeks,6 months,1 year, 2 years
Primary	Event-free Survival	the time from enrollment to any events, or the date of the last follow-up visit	12 weeks,6 months,1 year, 2 years
Secondary	Dose-limiting toxicity (DLT)	Non-haematological dose-limiting toxicities was any toxicity of grade 3 or higher occurring within 28 days of XLCART001 infusion judged possibly related to the treatment regimen.The following toxicities were not considered dose limiting toxicities: tumor lysis syndrome, abnormal electrolytes responding to supplementation, hypoalbuminemia, liver dysfunction resolving to =grade 2 within 14 days, transient (<72 hours) grade 4 hepatic enzyme abnormality, and grade 3 or 4 fever or neutropenic fever.	28 days
Secondary	Number of CAR-T cells	The number of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction	Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years
Secondary	Duration of CAR-T cells	The duration of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction	Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years