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XLCART001 Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

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

NCT03598179•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

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
+4 more criteria

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

Locations (1)

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

Nanjin, Jiangsu, China

Key Dates

Start Date

June 1, 2018

Primary Completion Date

December 30, 2019

Completion Date

July 1, 2020

Last Updated

August 7, 2019

Enrollment

ESTIMATED participants

Conditions

Lymphoma, B-CellLeukemia, B-cell

Interventions

chimeric antigen receptor T cells

BIOLOGICAL

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

NCT05254743

Chronic Lymphocytic LeukemiaLeukemia, Lymphocytic+2 more

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RECRUITINGEARLY_PHASE1

Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

NCT04161248

Lymphoma, B-Cell

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)

Study of a Communication Training Intervention for Large B-Cell Lymphoma Providers