CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

NCT03671460 | Unknown Phase 1

• 1 other identifier: TianjinMycure-LDP-CD19 CAR-T
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

Conditions

B-cell Acute Lymphoblastic Leukemia

Keywords

B-cell acute lymphoblastic leukemia; CD19 CAR-T

Outcome Measures

Primary Outcomes (1)

• Percentage of adverse events

  Percentage of participants with adverse events

  6 months

Secondary Outcomes (2)

• complete remission rate

  6 months

• objective remission rate

  6 months

Study Arms (1)

CD19-CAR-T Cells

EXPERIMENTAL

Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.

Biological: CD19 CAR-T cells

Interventions

CD19 CAR-T cells BIOLOGICAL

T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.

CD19-CAR-T Cells

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 1 year;
• CD19 positive B-cell acute lymphoblastic leukemia;
• Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.
• Expected to survive for more than 3 months;
• Informed consent is signed by a subject or his lineal relation.

You may not qualify if:

• Recent or current use of glucocorticoid or other immunosuppressor;
• Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
• Has a graft-versus-host response and requires the use of immunosuppressants；
• Drug uncontrollable central nervous system leukemia；
• Pregnant or lactating female；
• The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
• A history of other malignant tumors;

Sponsors & Collaborators

• Tianjin Mycure Medical Technology Co., Ltd: lead

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, 065000, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Peihua Lu, PhD,MD

  Hebei Yanda Ludaopei Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaoting Zhang, PhD

CONTACT

86-010-88196768; zhangchaoting1@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-center, open-label, nonrandomized, no control, prospective clinical trial

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 14, 2018
• Study Start: September 7, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

CN (1)