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

NCT ID: NCT04684472

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2024-01-01

Brief 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).

Conditions

Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified anti-CD19 CAR T cell therapy

CAR T cell therapy

Group Type: EXPERIMENTAL

Modified anti-CD19 CAR T cells

Intervention Type: BIOLOGICAL

intravenous infusion

Interventions

Modified anti-CD19 CAR T cells

intravenous infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

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;

11. Pregnant(or lactation) women;

12. Patients with severe active infections(excluding simple urinary tract infection and bacterial pharyngitis)within 30 days prior to randomization

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liqun Zou

OTHER

Sponsor Role: lead

Responsible Party

Liqun Zou

Professor of Department of Medical Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

liqun zou, phd

Role: PRINCIPAL_INVESTIGATOR

Sichuan University

Locations

Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

pei shu, MD

Role: CONTACT

peishu1991@sina.com

+86(028)85423525

fuchun guo, MD

Role: CONTACT

FCguo0797@wchscu.cn

+86(028)85423525

Facility Contacts

weiming li

Role: primary

Other Identifiers

MCART-003

Identifier Type: -

Identifier Source: org_study_id