- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03881774
Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies
March 19, 2019 updated by: Henan Cancer Hospital
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
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma.
However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells.
The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients.
We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450000
- Recruiting
- Henan Cancer Hospital
-
Zhengzhou, Henan, China
- Recruiting
- Henan Cancer Hospital
-
Contact:
- Yongping Song, M.D
- Phone Number: +86-37165587795
- Email: songyongping2018@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 70 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: experimental arm
cord blood derived CAR T cells group
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
occurrence of study related adverse events
Time Frame: one year
|
safety of CAR-T cells
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate
Time Frame: three months
|
the proportion of patients with CR or PR
|
three months
|
progression-free survival
Time Frame: one year
|
from the date of enrollment to the first date of progression detected
|
one year
|
overall survival
Time Frame: one year
|
from the date of enrollment to the date of death
|
one year
|
copy number of CAR-T
Time Frame: six months
|
copy number of CAR-T in blood and bone marrow
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 27, 2019
Primary Completion (ANTICIPATED)
January 31, 2021
Study Completion (ANTICIPATED)
January 31, 2022
Study Registration Dates
First Submitted
March 16, 2019
First Submitted That Met QC Criteria
March 16, 2019
First Posted (ACTUAL)
March 19, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 21, 2019
Last Update Submitted That Met QC Criteria
March 19, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HenanCH CART 2-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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