Back to resultsSafety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell Lymphoma
Primary Purpose
B-cell Malignancy
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ThisCART19 cells
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Malignancy
Eligibility Criteria
Inclusion Criteria:
- Age 18-70 years old, no gender and race limited;
- Estimated life expectancy > 12 weeks deemed by investigator；
- CD19 were positive by histopathology and/or cytology diagnosis；
- Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)；
- Relevant indicators for disease or assessment within 4 weeks after the last treatment;
- Quality of Life Score (KPS) >50%；
- Subject has adequate organ function at screening, cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); serum ALT/ AST <3 upper limit of normal (ULN); bilirubin<2.0 mg/dl; serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl;
- No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy;
- Unsuitable conditions for stem cell transplantation;
- Signed informed consent form (ICF).
Exclusion Criteria:
- Women in pregnancy or lactation;
- In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection；
- The absolute count of nonprimary neutrophil < 0.75×10^9/L or platelet count < 50×10^9/L;
- Abnormal vital signs and failure to cooperate with examination;
- Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
- Highly allergic constitution or history of severe allergy;
- Patients with systemic infection or severe local infection requiring anti-infection treatment;
- Patients with severe autoimmune diseases;
- Presence of any other conditions that are unsuitable for this study as judged by the investigator.
Sites / Locations
- The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ThisCART19 cells injections
Arm Description
In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies.
Outcomes
Primary Outcome Measures
Treatment related adverse events
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0
Secondary Outcome Measures
Overall Remission Rate (ORR)
Anti-tumor efficacy by 2014 Lugano criteria
Progression free survival time
The interval between administration and disease progression or death
Overall survival time
The interval between administration and death caused by any reason
Event-free survival (EFS)
EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.
Full Information
NCT ID
NCT05106907
First Posted
October 25, 2021
Last Updated
October 25, 2021
Sponsor
Fundamenta Therapeutics, Ltd.
Collaborators
The Affiliated Hospital of Xuzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05106907
Brief Title
Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell Lymphoma
Official Title
An Open and Single Dose-escalation Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD19(ThisCART19) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma (r/r B-NHL)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
October 24, 2023 (Anticipated)
Study Completion Date
October 24, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundamenta Therapeutics, Ltd.
Collaborators
The Affiliated Hospital of Xuzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
Detailed Description
ThisCART19 cell is a non-gene-editing allogeneic CAR-T cell targeting CD19. This study is designed to evaluate the safety and clinical activity of ThisCART19 in patients with CD19 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Malignancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ThisCART19 cells injections
Arm Type
Experimental
Arm Description
In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies.
Intervention Type
Biological
Intervention Name(s)
ThisCART19 cells
Intervention Description
0.2-60 x 10^6 CAR T cells per kg body weight
Primary Outcome Measure Information:
Title
Treatment related adverse events
Description
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0
Time Frame
90 days post infusion
Secondary Outcome Measure Information:
Title
Overall Remission Rate (ORR)
Description
Anti-tumor efficacy by 2014 Lugano criteria
Time Frame
up to 90 days
Title
Progression free survival time
Description
The interval between administration and disease progression or death
Time Frame
3 years
Title
Overall survival time
Description
The interval between administration and death caused by any reason
Time Frame
3 years
Title
Event-free survival (EFS)
Description
EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-70 years old, no gender and race limited;
Estimated life expectancy > 12 weeks deemed by investigator；
CD19 were positive by histopathology and/or cytology diagnosis；
Patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL)；
Relevant indicators for disease or assessment within 4 weeks after the last treatment;
Quality of Life Score (KPS) >50%；
Subject has adequate organ function at screening, cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO); serum ALT/ AST <3 upper limit of normal (ULN); bilirubin<2.0 mg/dl; serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl;
No remission or relapse after hematopoietic stem cell transplantation or autologous somatic immunotherapy;
Unsuitable conditions for stem cell transplantation;
Signed informed consent form (ICF).
Exclusion Criteria:
Women in pregnancy or lactation;
In active infection including hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection；
The absolute count of nonprimary neutrophil < 0.75×10^9/L or platelet count < 50×10^9/L;
Abnormal vital signs and failure to cooperate with examination;
Patients with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation;
Highly allergic constitution or history of severe allergy;
Patients with systemic infection or severe local infection requiring anti-infection treatment;
Patients with severe autoimmune diseases;
Presence of any other conditions that are unsuitable for this study as judged by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Li, Ph.D
Phone
18662604088
Email
jli@ctigen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengyu Li, Ph.D
Organizational Affiliation
The Affiliated Hospital of Xuzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhenyu li
Phone
15950688971
Email
lizhenyumd@163.com
12. IPD Sharing Statement
Learn more about this trial
Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell Lymphoma
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