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

Primary Purpose

Lymphoma, B-Cell, Leukemia, B-cell

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

chimeric antigen receptor T cells

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Overall response rate

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

Overall Survival

from the time of enrollment to death from any cause or the date of the last follow-up visit

Progression-free Survival

the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit

Event-free Survival

the time from enrollment to any events, or the date of the last follow-up visit

Secondary Outcome Measures

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.

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

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

Full Information

NCT ID

NCT03598179

First Posted

June 27, 2018

Last Updated

August 5, 2019

Sponsor

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03598179

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

December 30, 2019 (Anticipated)

Study Completion Date

July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, B-Cell, Leukemia, B-cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

chimeric antigen receptor T cells

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall response rate

Description

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

Time Frame

12 weeks

Title

Overall Survival

Description

from the time of enrollment to death from any cause or the date of the last follow-up visit

Time Frame

6 months,1 year, 2 years

Title

Progression-free Survival

Description

the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit

Time Frame

12 weeks,6 months,1 year, 2 years

Title

Event-free Survival

Description

the time from enrollment to any events, or the date of the last follow-up visit

Time Frame

12 weeks,6 months,1 year, 2 years

Secondary Outcome Measure Information:

Title

Dose-limiting toxicity (DLT)

Description

Time Frame

28 days

Title

Number of CAR-T cells

Description

The number of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction

Time Frame

Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years

Title

Duration of CAR-T cells

Description

The duration of CAR-T cells detected by flow cytometry and copy number of CAR-T cells tested by polymerase chain reaction

Time Frame

Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

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

City

Nanjin

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

34515338

Citation

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.

Results Reference

derived

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

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