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

NCT04684472 | Unknown Phase 1

• 1 other identifier: MCART-003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Modified CD19 CAR-T

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events [Safety and Tolerability]

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Up to 5 years after modified CD19 CAR-T cells infusion

• Dose-limiting toxicity (DLT)

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Baseline up to 28 days after modified CD19 CAR-T cells infusion

Secondary Outcomes (4)

• B-cell malignancies, Overall response rate(ORR)

  3 months, 6 months

• B-cell malignancies, Overall survival

  Up to 2 years after modified CD19 CAR-T cells infusion

• B-cell malignancies, progression-free survival（PFS）

  Up to 2 years after modified CD19 CAR-T cells infusion

• B-cell malignancies, disease control rate (DCR)

  Month 6,12,18 and 24

Study Arms (1)

Modified anti-CD19 CAR T cell therapy

EXPERIMENTAL

CAR T cell therapy

Biological: Modified anti-CD19 CAR T cells

Interventions

Modified anti-CD19 CAR T cells BIOLOGICAL

intravenous infusion

Modified anti-CD19 CAR T cell therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-70 years;
• Estimated survival time ≥ 12 weeks;
• Histologically confirmed diagnosis of CD19+ B-ALL or CD19+ B-NHL(meeting one of the following conditions):
• Ineffectively or relapses after 2 or more remedial treatments
• Relapse after auto-HSCT or unsuitable for auto-HSCT;
• At least one assessable tumor lesion;
• ECOG performance status 0 to 2;
• 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;
• Male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study;
• Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

You may not qualify if:

• Patients with other uncontrolled malignancies;
• Previously treated with any CAR-T cell product or other genetically-modified T cell therapy;
• Patients with HIV infection, hepatitis B (HBsAg positive) or hepatitis C（anti-HCV positive);
• Patients with central nervous system involvement by lymphoma ,malignant cells in cerebrospinal fluid or history of brain metastasis;
• Patients with atrial or ventricular involvement by B-cell malignancies;
• Patients with tumor mass require urgent treatment, such as ileus or vascular compression;
• 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;
• 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;
• Any situations that the investigators believes were not suitable for this trial;
• Long-term use of immunosuppressive agents after organ transplantation, except for the patients recently or currently receiving inhaled steroids;
• Pregnant(or lactation) women;
• Patients with severe active infections(excluding simple urinary tract infection and bacterial pharyngitis)within 30 days prior to randomization

Sponsors & Collaborators

• Liqun Zou: lead

Study Sites (1)

Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Leukemia

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Study Officials

• liqun zou, phd

  Sichuan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

pei shu, MD

CONTACT

+86(028)85423525; peishu1991@sina.com

fuchun guo, MD

CONTACT

+86(028)85423525; FCguo0797@wchscu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Department of Medical Oncology

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: March 17, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)