Back to resultsA Study of EXP039 Treatment in Subjects With r/r NHL Subjects
Primary Purpose
Non-Hodgkin's B-cell Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19/CD20-directed CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's B-cell Lymphoma focused on measuring CD19/CD20-directed CAR-T cells
Eligibility Criteria
Inclusion Criteria:
- The patient volunteered to participate in the study and signed the Informed Consent
- Age ≥18 years old ≤70 Years old, male or female
- Expected survival ≥ 12 weeks
- ECOG score 0-2
- CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria
- Patients with a clear diagnosis of relapsed and/or refractory B-NHL, including DLBCL, FL and MCL
- For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause of intolerance should be recorded
- No contraindications of apheresis
- At least one measurable lesion according to Lugano 2014 criteria
- Adequate organ function and adequate bone marrow reserve
Exclusion Criteria:
- Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
- Active HIV, HBV, HCV or treponema pallidum infection
- Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
- Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
- Patients who have been previously infected with tuberculosis
- Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of EXP039
- Patients with central nervous system involvement
- Any systemic antitumor therapy performed within 2 weeks before enrollment
- Previous use of any CAR T cell product or other genetically modified T cell therapy
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous EXP039 administered by intravenous (IV) infusion
Arm Description
Autologous EXP039 administered by intravenous (IV) infusion
Outcomes
Primary Outcome Measures
Occurrence of study related adverse events
Incidence and severity of Treatment emergent adverse events
Secondary Outcome Measures
Maximum concentration (Cmax) of EXP039 in the peripheral blood
Detect CAR-T copies number by qPCR
Time to maximum concentration (Tmax) of EXP039 in the peripheral blood
Detect CAR-T copies number by qPCR
Tlast of EXP039 in the peripheral blood after infusion
Detect CAR-T copies number by qPCR
AUC0h-28d of EXP039 in the peripheral blood
Detect CAR-T copies number by qPCR
Objective response rate (ORR)
Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria
Duration of response (DOR)
The time from the date of first response (PR or better) until the date of disease progression after EXP039 infusion
Progression-free survival (PFS)
The time from EXP039 infusion to the date of progression as assessed by Lugano 2014 criteria or death
Overall survival rate (OSR)
The time from EXP039 infusion to the date of death
Full Information
NCT ID
NCT04655677
First Posted
September 25, 2020
Last Updated
November 30, 2020
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04655677
Brief Title
A Study of EXP039 Treatment in Subjects With r/r NHL Subjects
Official Title
A Phase 1 Study Evaluating Safety and Efficacy of EXP039 Treatment in Subjects With Relapsed and/or Refractory NHL
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College 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-center, non-randomized study to evaluate the safety and efficacy of EXP039 in relapsed and/or refractory NHL patients.
Detailed Description
The study will include the following sequential phases: Screening, Apheresis, Baseline, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), EXP039 infusion and Follow-up Visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's B-cell Lymphoma
Keywords
CD19/CD20-directed CAR-T cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autologous EXP039 administered by intravenous (IV) infusion
Arm Type
Experimental
Arm Description
Autologous EXP039 administered by intravenous (IV) infusion
Intervention Type
Biological
Intervention Name(s)
CD19/CD20-directed CAR-T cells
Other Intervention Name(s)
EXP039
Intervention Description
Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
Primary Outcome Measure Information:
Title
Occurrence of study related adverse events
Description
Incidence and severity of Treatment emergent adverse events
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Maximum concentration (Cmax) of EXP039 in the peripheral blood
Description
Detect CAR-T copies number by qPCR
Time Frame
up to 12 months
Title
Time to maximum concentration (Tmax) of EXP039 in the peripheral blood
Description
Detect CAR-T copies number by qPCR
Time Frame
up to 12 months
Title
Tlast of EXP039 in the peripheral blood after infusion
Description
Detect CAR-T copies number by qPCR
Time Frame
up to 12 months
Title
AUC0h-28d of EXP039 in the peripheral blood
Description
Detect CAR-T copies number by qPCR
Time Frame
4 weeks
Title
Objective response rate (ORR)
Description
Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria
Time Frame
4 weeks, 12 weeks, 6 months, 9 months, 12 months
Title
Duration of response (DOR)
Description
The time from the date of first response (PR or better) until the date of disease progression after EXP039 infusion
Time Frame
up to 12 months
Title
Progression-free survival (PFS)
Description
The time from EXP039 infusion to the date of progression as assessed by Lugano 2014 criteria or death
Time Frame
4 weeks, 12 weeks, 6 months, 9 months, 12 months
Title
Overall survival rate (OSR)
Description
The time from EXP039 infusion to the date of death
Time Frame
12 weeks, 6 months, 12 months
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:
The patient volunteered to participate in the study and signed the Informed Consent
Age ≥18 years old ≤70 Years old, male or female
Expected survival ≥ 12 weeks
ECOG score 0-2
CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria
Patients with a clear diagnosis of relapsed and/or refractory B-NHL, including DLBCL, FL and MCL
For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause of intolerance should be recorded
No contraindications of apheresis
At least one measurable lesion according to Lugano 2014 criteria
Adequate organ function and adequate bone marrow reserve
Exclusion Criteria:
Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
Active HIV, HBV, HCV or treponema pallidum infection
Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
Patients who have been previously infected with tuberculosis
Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of EXP039
Patients with central nervous system involvement
Any systemic antitumor therapy performed within 2 weeks before enrollment
Previous use of any CAR T cell product or other genetically modified T cell therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daobin Zhou, PhD&MD
Phone
010-69155020
Email
zhoudb@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhang
Phone
010-69155660
Email
zhangyan10659@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daobin Zhou, PhD&MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing/China
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daobin Zhou, PhD&MD
Phone
010-69155020
Email
zhoudb@pumch.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of EXP039 Treatment in Subjects With r/r NHL Subjects
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