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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03598179

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, B-Cell Leukemia, B-cell	Biological: chimeric antigen receptor T cells	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Dec 30, 2019

Anticipated Study Completion Date :

Jul 1, 2020

Outcome Measures

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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.
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital	Nanjin	Jiangsu	China	210029

Sponsors and Collaborators

The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

JianYong Li, Professor, The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT03598179

Other Study ID Numbers:

JSPH-CART001

First Posted:

Jul 26, 2018

Last Update Posted:

Aug 7, 2019

Last Verified:

Aug 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma, B-Cell

Leukemia, B-Cell

Study Results

No Results Posted as of Aug 7, 2019