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

NCT04287309 | Unknown DMC

• 1 other identifier: 19-002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematological Malignancy

Outcome Measures

Primary Outcomes (1)

• Adverse events that related to treatment

  Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

  2 years

Secondary Outcomes (1)

• The response rate of CAR-T treatment in patients with relapse/refractory B cell malignancies involved in CNS that treated by CD19 CAR-T cells therapy

  6 months

Interventions

CAR-T cells OTHER

CD19 targeted CAR-T treatment

Eligibility Criteria

• Age: 3 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CNS involvement

You may qualify if:

• 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.

You may not qualify if:

• Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome;
• extensive involvement of gastrointestinal lymphoma;
• radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;
• Have a history of allergy to any of the components in the cell products;
• According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency;
• Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment;
• Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999);
• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis).
• 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;
• History of other primary cancer, except for the following conditions:
• Cured non-melanoma after resection, such as basal cell carcinoma of the skin;
• Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival ≥ 2 years after adequate treatment;
• Patients with graft-versus-host disease (GVHD);
• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (2)

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

the First Affiliated Hospital,School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood and cerebral fluid for CAR-T cell expansion, serum for cytokine concerntraion.

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

He Huang, PhD

CONTACT

13605714822; huanghe@zju.edu.cn

Yongxian Hu, PhD

CONTACT

15957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: February 27, 2020
• Study Start: February 28, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2023
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

CN (2)