Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies
Clinical Study of Cord Blood Derived CAR-T Cells in Patients With Refractory/Relapsed B Cell Leukemia/Lymphoma Who Are Failed for Autologous CAR-T Cells or Autologous CAR-T Can Not be Prepared
1 other identifier
interventional
20
1 country
2
Brief Summary
Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2019
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2019
CompletedFirst Submitted
Initial submission to the registry
March 16, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedMarch 21, 2019
March 1, 2019
1.9 years
March 16, 2019
March 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
occurrence of study related adverse events
safety of CAR-T cells
one year
Secondary Outcomes (4)
objective response rate
three months
progression-free survival
one year
overall survival
one year
copy number of CAR-T
six months
Study Arms (1)
experimental arm
EXPERIMENTALcord blood derived CAR T cells group
Interventions
collecting cord blood for CAR-T cells culture; three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CAR-T cell with a dose of 0.5-3x106/kg
Eligibility Criteria
You may qualify if:
- expected lifespan \>3 months
- patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails
- KPS \>70
- for patients with lymphoma, at least one measurable lesion according to RECIST 1.1
- enough function of heart, liver, kidney and bone marrow
- no history of severy allergy
- no other serious diseases that conflict with this plan
- no other history of malignancy
- no serious mental illness
- patients and their families members agree to participate in this clinical study and sign the Informed Consent Form
You may not qualify if:
- pregnant or lactating women
- vevere infectious or viral diseases
- active hepatitis B or C viral hepatitis
- Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks
- participated in other clinical studies in the past 3 months or who have been treated with other gene products;
- others that other investigators consider not suitable for this clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henan Cancer Hospitallead
- Henan Hualong Biotechnology Companycollaborator
Study Sites (2)
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Henan Cancer Hospital
Zhengzhou, Henan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yongping Song, Dr.
Henan Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2019
First Posted
March 19, 2019
Study Start
February 27, 2019
Primary Completion
January 31, 2021
Study Completion
January 31, 2022
Last Updated
March 21, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share