- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04648475
Safety and Efficacy of CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma
April 16, 2023 updated by: Chongqing Precision Biotech Co., Ltd
CD19 and CD22 Targeted CAR-T Cell Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma
This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Leukemia and Lymphoma.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Although the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma.
There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse.
To make further improvement, We launch such a clinical trial using CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Leukemia and Lymphoma to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cell therapy.
Study Type
Interventional
Enrollment (Anticipated)
40
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
-
-
Chongqing
-
Chongqing, Chongqing, China
- Recruiting
- Chongqing University Cancer Hospital
-
-
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
3 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 and CD22 expression;
- All genders, ages: 3 to 75 years;
- The expect time of survive is above 12 weeks;
- 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:
- Have received CAR-T therapy or other genetically modified cell therapy before screening;
- Participated in other clinical research within 1 month before screening;
- Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;
- Live attenuated vaccine within 4 weeks before screening;
- Convulsion or stoke within past 6 months;
- Previous history of other malignancy;
- Presence of uncontrolled active infection;
- Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;
- Pregnant or breasting-feeding women;
- Any situation that investigators regard not suitable for attending in this study 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: Arm 1
CD19 and CD22 targeted CAR-T cells treat
|
A single infusion of CD19 and CD22 CAR-T cells will be administered intravenously
|
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 and CD22 CAR-T treatment in patients with relapse/refractory B Cell Leukemia and Lymphoma
Time Frame: 6 months
|
The response rate of CD19 and CD22 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of IL-6 in Serum
Time Frame: 3 months
|
In vivo (Serum) quantity of IL-6
|
3 months
|
Levels of CRP in Serum
Time Frame: 3 months
|
In vivo (Serum) quantity of CRP
|
3 months
|
Rate of CD19 and CD22 CAR-T cells in bone marrow and peripheral blood
Time Frame: 2 years
|
In vivo (bone marrow and peripheral blood) rate of CD19 and CD22 CAR-T cells were determined by means of flow cytometry
|
2 years
|
Quantity of CD19 and CD22 CAR copies in bone marrow and peripheral blood
Time Frame: 2 years
|
In vivo (bone marrow and peripheral blood) quantity of CD19 and CD22 CAR copies were determined by means of qPCR
|
2 years
|
Cellular kinetics of CD19 and CD22 positive cells in Bone marrow
Time Frame: 1 years
|
In vivo (bone marrow) rate and quantity of CD19 and CD22 positive cells were determined by means of flow cytometry
|
1 years
|
Levels of IL-10 in Serum
Time Frame: 3 months
|
In vivo (Serum) quantity of IL-10
|
3 months
|
Levels of TNF-α in Serum
Time Frame: 3 months
|
In vivo (Serum) quantity of TNF-α
|
3 months
|
Duration of Response (DOR) of CD19 and CD22 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/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 and CD22 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 and CD22 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)
August 25, 2020
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
July 1, 2024
Study Registration Dates
First Submitted
August 30, 2020
First Submitted That Met QC Criteria
November 29, 2020
First Posted (Actual)
December 1, 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
Other Study ID Numbers
- PBC019
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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