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

Phase 2

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

• Registration Number: NCT03598179
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-06-27
• Study First Submitted QC: 2018-07-14
• Study First Posted: 2018-07-26
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07
• Primary Completion: 2019-12-30
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate	12 weeks	Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 12.
Overall Survival	6 months,1 year, 2 years	from the time of enrollment to death from any cause or the date of the last follow-up visit
Event-free Survival	12 weeks,6 months,1 year, 2 years	the time from enrollment to any events, or the date of the last follow-up visit
Progression-free Survival	12 weeks,6 months,1 year, 2 years	the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit

Secondary Outcome Measures

Name	Time	Method
Duration of CAR-T cells	Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years	The duration of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction
Number of CAR-T cells	Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years	The number of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction
Dose-limiting toxicity (DLT)	28 days	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.

Trial Locations

Locations (1)

Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital; 🇨🇳 Nanjin, Jiangsu, China