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

Sponsor

Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04287309

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Malignancy	Other: CAR-T cells

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

CAR-T Cellular Therapy for B Cell Malignancies Involved in Central Nervous System

Anticipated Study Start Date :

Feb 28, 2020

Anticipated Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Outcome Measures

Primary Outcome Measures

Adverse events that related to treatment [2 years]
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)

Secondary Outcome Measures

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]
The response rate of BCMA CAR-T treatment will be recorded and assessed according to WHO criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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);

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Hospital of Zhejiang Medical Colleage Zhejiang University	Hangzhou	Zhejiang	China	310000
2	the First Affiliated Hospital,School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

He Huang, Professor, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04287309

Other Study ID Numbers:

19-002

First Posted:

Feb 27, 2020

Last Update Posted:

Feb 27, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Study Results

No Results Posted as of Feb 27, 2020