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

The First Affiliated Hospital with Nanjing Medical University1 site in 1 country10 target enrollmentJune 1, 2018

ConditionsLymphoma, B-Cell Leukemia, B-cell

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Lymphoma, B-Cell
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Enrollment: 10
Locations: 1
Primary Endpoint: Overall response rate
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 1, 2018

End Date

July 1, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Responsible Party

Principal Investigator

JianYong Li

Professor

The First Affiliated Hospital with Nanjing Medical University

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

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

Outcomes

Primary Outcomes

Overall response rate

Time Frame: 12 weeks

Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 12.

Overall Survival

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

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)
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)
Dose-limiting toxicity (DLT)(28 days)