Back to resultsAutologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Primary Purpose
Lymphoma
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous hematopoietic stem cell transplantation combined with CD19 CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring ASCT, CD19 CAR-T
Eligibility Criteria
Inclusion Criteria:
1.Male or female, 18-75 years old (including the threshold value); 2. According to the 2016 WHO classification criteria for lymphocytic tumors, histologically confirmed include: DLBCL (NOS); follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma transformed DLBCL, and PMBCL and high-grade B-cell lymphoma Subject.
3.R/R B-NHL (conform one of the following conditions)
- The subject did not remission or relapsed after receiving second-line or higher-line chemotherapy
- Primary resistance
The subject relapsed after receiving autologous hematopoietic stem cell transplantation
Exclusion Criteria:
Subjects with any of the following exclusion criteria were not eligible for this trial:
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Those who have used any gene therapy products before.
- The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- Those who suffer from other uncontrolled diseases are not suitable to join the study;
- HIV infection;
- Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Sites / Locations
- The first affiliated hospital of medical college of zhejiang universityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment of Lymphoma
Arm Description
Refractory and relapsed malignant lymphoma
Outcomes
Primary Outcome Measures
overall response rate
the number of response patients/the number of total patients
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Secondary Outcome Measures
Overall response rate(ORR)
Assessment of ORR (ORR = CR + CRi ) at Month 1,3,6,12,18and 24
Progression-free survival (PFS)
Assessment of PFS at Month 6,12,18and 24
Overall survival (OS)
Assessment of OS at Month 6,12,18and 24
Duration of response(DOR)
Assessment of OS at Month 6,12,18and 24
Full Information
NCT ID
NCT05239676
First Posted
December 1, 2021
Last Updated
February 13, 2022
Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05239676
Brief Title
Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Official Title
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
Detailed Description
Current studies have shown that under standard treatment, patients with large masses and high-grade DLBCL have a poor prognosis. Data from major centers around the world on CAR-T cell treatment of relapsed and refractory B-cell NHL show that CAR-T treatment of relapsed and refractory B-cell NHL has a low complete remission rate but a low recurrence rate after remission.Therefore, new treatment options are urgently needed to achieve long-term relief.
CD19 CAR-T therapy as a consolidation therapy after high-dose melphalan and autologous hematopoietic stem cell transplantation has been used in a refractory MM patient at the University of Pennsylvania, and good research progress has been made. Craig S et al. studied the safety and effectiveness of CD19 CAR-T cell therapy after high-dose chemotherapy and autologous stem cell transplantation HDT-ASCT. The object of the study was relapsed and refractory non-Hodgkin's lymphoma, with 2-year progression-free survival ( PFS) is 30%.
Therefore, autologous hematopoietic stem cell transplantation combined with CAR-T cell therapy is expected to improve the complete remission rate and long-term survival rate. In summary, the center intends to apply for a clinical trial of autologous hematopoietic stem cell transplantation combined with CAR-T cells for the treatment of refractory and relapsed non-Hodgkin's lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
ASCT, CD19 CAR-T
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment of Lymphoma
Arm Type
Experimental
Arm Description
Refractory and relapsed malignant lymphoma
Intervention Type
Biological
Intervention Name(s)
Autologous hematopoietic stem cell transplantation combined with CD19 CAR-T cells
Intervention Description
The patient receives ECHOP chemotherapy or other chemotherapy regimens； G-CSF in the low cell stage mobilizes hematopoietic stem cells and freezes them for later use after collection； Autologous hematopoietic stem cells and prepared CD19 CAR-T cells are reinfused into the patient
Primary Outcome Measure Information:
Title
overall response rate
Description
the number of response patients/the number of total patients
Time Frame
Up to 30 months
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Time Frame
24 months after cell infusion
Secondary Outcome Measure Information:
Title
Overall response rate(ORR)
Description
Assessment of ORR (ORR = CR + CRi ) at Month 1,3,6,12,18and 24
Time Frame
Month 1,3,6,12,18and 24
Title
Progression-free survival (PFS)
Description
Assessment of PFS at Month 6,12,18and 24
Time Frame
Month 6,12,18and 24
Title
Overall survival (OS)
Description
Assessment of OS at Month 6,12,18and 24
Time Frame
Month 6,12,18and 24
Title
Duration of response(DOR)
Description
Assessment of OS at Month 6,12,18and 24
Time Frame
Month 6,12,18and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Male or female, 18-75 years old (including the threshold value); 2. According to the 2016 WHO classification criteria for lymphocytic tumors, histologically confirmed include: DLBCL (NOS); follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma transformed DLBCL, and PMBCL and high-grade B-cell lymphoma Subject.
3.R/R B-NHL (conform one of the following conditions)
The subject did not remission or relapsed after receiving second-line or higher-line chemotherapy
Primary resistance
The subject relapsed after receiving autologous hematopoietic stem cell transplantation
Exclusion Criteria:
Subjects with any of the following exclusion criteria were not eligible for this trial:
History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
Pregnant (or lactating) women;
Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
Active infection of hepatitis B virus or hepatitis C virus;
Those who have used any gene therapy products before.
The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
Those who suffer from other uncontrolled diseases are not suitable to join the study;
HIV infection;
Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, PhD
Phone
+8613605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongxian Hu, PhD
Phone
+8615957162012
Email
huyongxian2000@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He Huang, PhD
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of medical college of zhejiang university
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Huang, PhD
Phone
86-13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name & Degree
Yongxian Hu, PhD
Phone
+8615957162012
Email
huyongxian2000@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Malignant Lymphoma
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