Back to resultsSafety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
Primary Purpose
Lymphoma, B-Cell
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19 and CD22 targeted CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring CAR-T, Lymphoma
Eligibility Criteria
Inclusion Criteria: Relapsed or refractory B cell non-hodgkin lymphoma. KPS>60. Life expectancy>12 weeks. Gender unlimited, age from 3 years to 70 years. Evidence for cell membrane CD19 and/or CD22 expression; Patients who have failed at least one line of a standard treatment. No serious mental disorder. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L). No other serious diseases(autoimmune disease, immunodeficiency etc.). No other tumors. Patients volunteer to participate in the research. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial Exclusion Criteria: Pregnancy and nursing females. Patients are allergic to cytokines. Uncontrolled active infection. Acute or chronic GVHD. Treated with T cell inhibitor. Patients who had used steroid hormones within one week. Patients who had used Rituximab within two weeks. HIV/HBV/HCV Infection. Other situations we think improper for the research.
Sites / Locations
- Hebei Yanda Ludaopei Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
arm 1
Arm Description
sequential CD19 and CD22 targeted CAR-T cells treat
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).
Overall remission rate (ORR)
The ORR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Secondary Outcome Measures
complete response(CR)
The CR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
partial response(PR)
The PR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
stable disease(SD)
The SD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
progressive disease(PD)
The PD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Duration of remission (DOR)
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.
Full Information
NCT ID
NCT05651100
First Posted
November 26, 2022
Last Updated
December 6, 2022
Sponsor
Kecellitics Biotech Company Ltd
Collaborators
Hebei Yanda Ludaopei Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05651100
Brief Title
Safety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
Official Title
Phase 1/Phase 2 Study of Sequential Chimeric Antigen Receptor T Cell Targeting at CD19 and CD22 B-cell Antigens Treating Refractory or Relapsed B-cell Lymphoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 10, 2022 (Anticipated)
Primary Completion Date
December 10, 2024 (Anticipated)
Study Completion Date
December 10, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kecellitics Biotech Company Ltd
Collaborators
Hebei Yanda Ludaopei Hospital
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 Sequential CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma.
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 some patients who resisted anti-CD19 CAR-T cells or get CD19 negative relapse. To make further improvement, We launch such a clinical trial using sequential CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Lymphoma to evaluate the efficacy and safety of sequential CD19 and CD22 targeted CAR-T cell therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell
Keywords
CAR-T, Lymphoma
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
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
arm 1
Arm Type
Experimental
Arm Description
sequential CD19 and CD22 targeted CAR-T cells treat
Intervention Type
Biological
Intervention Name(s)
CD19 and CD22 targeted CAR-T cells
Intervention Description
CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (300 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In sequential CAR-T clinical trials, CAR-T cells will be given.（anti-CD19 CAR-T first, then anti-CD22 CAR-T).
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
1 years
Title
Overall remission rate (ORR)
Description
The ORR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
complete response(CR)
Description
The CR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Time Frame
24 months
Title
partial response(PR)
Description
The PR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Time Frame
24 months
Title
stable disease(SD)
Description
The SD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Time Frame
24 months
Title
progressive disease(PD)
Description
The PD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Time Frame
24 months
Title
Duration of remission (DOR)
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory B cell non-hodgkin lymphoma.
KPS>60.
Life expectancy>12 weeks.
Gender unlimited, age from 3 years to 70 years.
Evidence for cell membrane CD19 and/or CD22 expression;
Patients who have failed at least one line of a standard treatment.
No serious mental disorder.
Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
No other serious diseases(autoimmune disease, immunodeficiency etc.).
No other tumors.
Patients volunteer to participate in the research.
Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial
Exclusion Criteria:
Pregnancy and nursing females.
Patients are allergic to cytokines.
Uncontrolled active infection.
Acute or chronic GVHD.
Treated with T cell inhibitor.
Patients who had used steroid hormones within one week.
Patients who had used Rituximab within two weeks.
HIV/HBV/HCV Infection.
Other situations we think improper for the research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
li xiangqun, doctor
Phone
086-15712867910
Email
xiangqun_li@doingtimes.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li xiangqun, doctor
Organizational Affiliation
Kecellitics Biotech Company Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Hebei Yanda Ludaopei Hospital
City
Langfang
State/Province
Hebei
ZIP/Postal Code
065201
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li xiangqun, Doctor
Phone
086-15712867910
Email
xiangqun_li@doingtimes.com
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
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