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UNKNOWNPHASE1

Modified CD19 CAR-T in Patients With Relapsed or Refractory CD19+ B-cell Malignancies

Phase I, Open Label, Study of CXCR4 Modified CD19 CAR-T Therapy in Patients With Relapsed or Refractory CD19+ B-cell Malignancies

NCT04684472•Liqun Zou

View on ClinicalTrials.gov

Summary

This study aims to evaluate the safety and tolerance of modified CD19 CAR T cells in treating refractory/relapsed B-cell malignancies. CAR-T cells will be investigated as a single agent both in relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL) and up to 60% of patients with B-cell non-Hodgkin's lymphoma (NHL).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female aged 18-70 years;
•2. Estimated survival time ≥ 12 weeks;
•3. Histologically confirmed diagnosis of CD19+ B-ALL or CD19+ B-NHL(meeting one of the following conditions):
•1. Ineffectively or relapses after 2 or more remedial treatments
•2. Relapse after auto-HSCT or unsuitable for auto-HSCT;
•4. At least one assessable tumor lesion;
•5. ECOG performance status 0 to 2;
•6. Creatinine clearance rate≥ 60 ml/min, ALT and AST ≤ 2.5 times of upper limit of normal, total bilirubin ≤ 1.5 times of upper limit of normal;
•7. Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study;
•8. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria

•1. Patients with other uncontrolled malignancies;
•2. Previously treated with any CAR-T cell product or other genetically-modified T cell therapy;
•3. Patients with HIV infection, hepatitis B (HBsAg positive) or hepatitis C（anti-HCV positive);
•4. Patients with central nervous system involvement by lymphoma ,malignant cells in cerebrospinal fluid or history of brain metastasis;
•5. Patients with atrial or ventricular involvement by B-cell malignancies;
•6. Patients with tumor mass require urgent treatment, such as ileus or vascular compression;
•7. Patients with severe disease or other uncontrolled diseases that were not suitable for this trial, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, grade 2-3 hypertension;
•8. Unstable pulmonary embolism, deep venous embolism, or other major arterial/venous thromboembolism events occurred within 30 days prior to randomization. If patients receive anticoagulant therapy, the treatment dose must be stable prior to randomization;
•9. Any situations that the investigators believes were not suitable for this trial;
•10. Long-term use of immunosuppressive agents after organ transplantation, except for the patients recently or currently receiving inhaled steroids;
+2 more criteria

Locations (1)

Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

March 17, 2021

Primary Completion Date

January 1, 2023

Completion Date

January 1, 2024

Last Updated

September 26, 2022

Enrollment

ESTIMATED participants

Conditions

Refractory B-Cell Non-Hodgkin LymphomaRefractory Leukemia

Interventions

Modified anti-CD19 CAR T cells

BIOLOGICAL

Contacts

pei shu, MD

CONTACT

+86(028)85423525 peishu1991@sina.com

fuchun guo, MD

CONTACT

+86(028)85423525 FCguo0797@wchscu.cn

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

NCT06189391

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

View study

RECRUITING

Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies

NCT04470947

Advanced LymphomaRefractory Lymphoma+3 more

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: September 26, 2022Data 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.

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Modified CD19 CAR-T in Patients With Relapsed or Refractory CD19+ B-cell Malignancies

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies

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