CAR-T Cellular Therapy for B Cell Malignancies Involved in CNS

NCT ID: NCT04287309

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-28
• Study Completion Date: 2023-02-28

Brief Summary

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. 20 patients were enrolled. Primary objective is to explore the safety. The secondary objective is to explore the efficacy.

Detailed Description

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. All together 20 patients were enrolled. Primary objective is to explore the safety including the complication of cytokine release syndrome, CRES, pancytopenia and infection. The secondary objective is to explore the efficacy. We will also detect CAR-T cell expansion dynamics in blood and cerebral fluid and compare the difference.

Conditions

Hematological Malignancy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

CAR-T cells

CD19 targeted CAR-T treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1.Male or female aged ≥ 3 and <70 years old; 2.Histologically confirmed diagnosis of CD19+ B cell malignancies involved in CNS 3.Relapsed or refractory CD19+ B cell malignancies 4.total bilirubin ≤ 51umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol/L; 5.Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; 6.No active infection in the lungs, blood oxygen saturation by sucking air is ≥ 92%; 7.Estimated survival time ≥ 3 months; 8.ECOG performance status 0 to 2; 8.Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria

1. Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome;

2. extensive involvement of gastrointestinal lymphoma;

3. radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;

4. Have a history of allergy to any of the components in the cell products;

5. According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency;

6. Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment;

7. Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999);

8. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;

9. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis).

10. Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural/peritoneal/pericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed;

11. History of other primary cancer, except for the following conditions:

1. Cured non-melanoma after resection, such as basal cell carcinoma of the skin;

2. Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival ≥ 2 years after adequate treatment;

12. Patients with graft-versus-host disease (GVHD);

19.Prior immunizations with live vaccine 4 weeks prior to screening; 13.History of alcoholism, drug abuse or mental illness; 14.Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids; 15.Patients who have participated in any other clinical studies within 2 weeks prior to screening; 16.pregnant and breast-feeding women and the subjects who are fertile and unable to take effective contraceptive measures (regardless of the gender); 17.Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

the First Affiliated Hospital,School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, PhD

Role: CONTACT

huanghe@zju.edu.cn

13605714822

Yongxian Hu, PhD

Role: CONTACT

huyongxian2000@aliyun.com

15957162012

Facility Contacts

He Huang, PhD

Role: primary

huanghe@zju.edu.cn

86-13605714822

Yongxian Hu, Dr

Role: primary

huyongxian2000@aliyun.com

15957162012

Other Identifiers

19-002

Identifier Type: -

Identifier Source: org_study_id