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a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma

Primary Purpose

B Cell Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19 and CD22 targeted prime CAR- T cells
Sponsored by
Chongqing Precision Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Cell Lymphoma focused on measuring CD19, CD22, CAR-T

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed written informed consent
  2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:

    1. Failed to standard chemotherapy regimens;
    2. Relapse after complete remission, high-risk and / or refractory patients ;
    3. Relapse after hematopoietic stem cell transplantation;
  3. Evidence for cell membrane CD19 or CD22 expression
  4. All genders ages: 2 to 75 years
  5. The expect time of survive is above 3 months;
  6. KPS>60
  7. No serious mental disorders ;
  8. Left ventricular ejection fraction ≥50%
  9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
  10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
  11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
  12. With single or venous blood collection standards, and no other cell collection contraindications;
  13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

  1. Previous history of other malignancy;
  2. Presence of uncontrolled active infection;
  3. Evidence of disorder that need the treatment by glucocorticoids;
  4. Active or chronic GVHD
  5. The patients treatment by inhibitor of T cell
  6. Pregnant or breasting-feeding women;
  7. 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.

Sites / Locations

  • 920th Hospital of Joint Logistics Support ForceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

prime CAR- T cells

Arm Description

Patients will be be treated with CD19 and CD22 prime CAR- T cells

Outcomes

Primary Outcome Measures

Adverse events that related to treatment
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)
The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B Cell Lymphoma
The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline

Secondary Outcome Measures

Rate of prime CAR-T cells in bone marrow
Determine the rate of prime CAR-T cells in bone marrow by means of flow cytometry
Rate of prime CAR-T cells in peripheral blood
Determine the rate of prime CAR-T cells in peripheral blood by means of flow cytometry
Quantity of prime CAR copies in bone marrow
Determine the quantity of prime CAR copies in bone marrow by qPCR
Quantity of prime CAR copies in peripheral blood
Determine the quantity of prime CAR copies in peripheral blood by qPCR
Rate of CD19 and CD22 positive cells in Bone marrow
Determine the rate of CD19 and CD22 positive cells in bone marrow by flow cytometry
Levels of IL-6 in Serum
Serological determination of IL-6
Levels of IL-10 in Serum
Serological determination of IL-10
Levels of TNF-α in Serum
Serological determination of TNF-α
Levels of CRP in Serum
Serological determination of CRP
Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
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)
Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
OS will be assessed from the first primeCAR-T cell infusion to death from any cause (censored)

Full Information

First Posted
February 26, 2021
Last Updated
April 16, 2023
Sponsor
Chongqing Precision Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04782193
Brief Title
a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
Official Title
Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory B Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chongqing Precision Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma
Detailed Description
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B Cell Lymphomato evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Lymphoma
Keywords
CD19, CD22, CAR-T

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prime CAR- T cells
Arm Type
Experimental
Arm Description
Patients will be be treated with CD19 and CD22 prime CAR- T cells
Intervention Type
Biological
Intervention Name(s)
CD19 and CD22 targeted prime CAR- T cells
Intervention Description
A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously
Primary Outcome Measure Information:
Title
Adverse events that related to treatment
Description
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)
Time Frame
2 years
Title
The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B Cell Lymphoma
Description
The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of prime CAR-T cells in bone marrow
Description
Determine the rate of prime CAR-T cells in bone marrow by means of flow cytometry
Time Frame
2 years
Title
Rate of prime CAR-T cells in peripheral blood
Description
Determine the rate of prime CAR-T cells in peripheral blood by means of flow cytometry
Time Frame
2 years
Title
Quantity of prime CAR copies in bone marrow
Description
Determine the quantity of prime CAR copies in bone marrow by qPCR
Time Frame
2 years
Title
Quantity of prime CAR copies in peripheral blood
Description
Determine the quantity of prime CAR copies in peripheral blood by qPCR
Time Frame
2 years
Title
Rate of CD19 and CD22 positive cells in Bone marrow
Description
Determine the rate of CD19 and CD22 positive cells in bone marrow by flow cytometry
Time Frame
1 years
Title
Levels of IL-6 in Serum
Description
Serological determination of IL-6
Time Frame
3 months
Title
Levels of IL-10 in Serum
Description
Serological determination of IL-10
Time Frame
3 months
Title
Levels of TNF-α in Serum
Description
Serological determination of TNF-α
Time Frame
3 months
Title
Levels of CRP in Serum
Description
Serological determination of CRP
Time Frame
3 months
Title
Duration of Response (DOR) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
Description
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)
Time Frame
2 years
Title
Progress-free survival(PFS) of CD19 and CD22 targeted prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
Description
PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
Time Frame
2 years
Title
Overall survival(OS) of CD19 and CD22 prime CAR-T treatment in patients with refractory/relapsed B Cell Lymphoma
Description
OS will be assessed from the first primeCAR-T cell infusion to death from any cause (censored)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed written informed consent Diagnose as Relapsed and Refractory B -ALL, 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; Evidence for cell membrane CD19 or CD22 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Yang, PhD
Phone
86-13206140093
Email
yangzhi@precision-biotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sanbin Wang, MD
Email
Sanbin1011@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanbin Wang, MD
Organizational Affiliation
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheng Qian, PhD
Organizational Affiliation
Chongqing University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
920th Hospital of Joint Logistics Support Force
City
Kunming
State/Province
Yunnnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanbin Wang, MD
Email
Sanbin1011@163.com
First Name & Middle Initial & Last Name & Degree
Sanbin Wang, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma

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