- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04271410
CD19+Targeted CAR-T Cell Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma
April 16, 2023 updated by: Chongqing Precision Biotech Co., Ltd
This is a single arm study to evaluate the efficacy and safety of CD19-targeted CAR-T cells therapy for patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
There are limited options for treatment of relapse/refractory B Cell Leukemia and Lymphoma.CD19 is expressed on most B Cell Leukemia and Lymphoma cells so it is an ideal target for CAR-T.
In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD19 in patients with elapsed/refractory CD19+ B Cell Leukemia and Lymphoma.
The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
- 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
-
-
Yunnan
-
Kunming, Yunnan, China
- Recruiting
- 920th Hospital of Joint Logistics Support Force
-
-
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
2 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Signed written informed consent;
Diagnose as relapsed/refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:
- Failed to standard chemotherapy regimens;
- Relapse after complete remission, high-risk and / or refractory patients ;
- Relapse after hematopoietic stem cell transplantation;
- For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients);
- Evidence for cell membrane CD19 expression;
- All genders ,ages: 2 to 75 years;
- The expect time of survive is above 3 months;
- KPS>60;
- No serious mental disorders ;
- Left ventricular ejection fraction ≥50%
- Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
- Sufficient renal function defined by creatinine clearance≤2 x ULN;
- Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
- With single or venous blood collection standards, and no other cell collection contraindications;
- Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion Criteria:
- Previous history of other malignancy;
- Presence of uncontrolled active infection;
- Evidence of disorder that need the treatment by glucocorticoids;
- Active or chronic GVHD;
- The patients treatment by inhibitor of T cell;
- Pregnant or breasting-feeding women;
- Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CD19 CAR-T cells treat
Patients will be be treated with CD19 CAR-T cells
|
CD19 CAR-T cell therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events that related to treatment
Time Frame: 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)
|
2 years
|
The response rate of CD19 CAR-T treatment in patients with relapse/refractory B Cell Leukemia and Lymphoma that treatment by CD19 CAR-T cells therapy
Time Frame: 2 years
|
The response rate of CD19 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of CD19 CAR-T cells in bone marrow and peripheral blood
Time Frame: 2 years
|
In vivo (bone marrow and peripheral blood) rate of CD19 CAR-T cells were determined by means of flow cytometry
|
2 years
|
Quantity of CD19 CAR copies in bone marrow and peripheral blood
Time Frame: 2 years
|
In vivo (bone marrow and peripheral blood) quantity of CD19 CAR copies were determined by means of qPCR
|
2 years
|
Cellular kinetics of CD19 positive cells in bone marrow
Time Frame: 1 years
|
In vivo (bone marrow) rate and quantity of CD19 positive cells were determined by means of flow cytometry
|
1 years
|
Duration of Response (DOR) of CD19 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma
Time Frame: 2 years
|
DOR will be assessed from the first assessment of CR or CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)
|
2 years
|
Progress-free survival(PFS) of CD19 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma
Time Frame: 2 years
|
PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
|
2 years
|
Overall survival(OS) of CD19 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma
Time Frame: 2 years
|
OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
June 1, 2019
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
February 13, 2020
First Submitted That Met QC Criteria
February 14, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 16, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Leukemia, B-Cell
Other Study ID Numbers
- PBC004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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