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Clinical Study of Autologous Stem Cell Transplantation + Anti-CD19 CAR T Cells for B-cell Lymphoma

Primary Purpose

B-cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ASCT+CAR-T Cell Infusion
Sponsored by
The Affiliated Hospital of Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Lymphoma focused on measuring Anti-CD19 CAR-T, Autologous stem cell transplantation, Combination therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients or their legal guardians voluntarily participate and sign the informed consent; Male or female patients aged 18-70 years (including 18 and 70 years); CD19+ B-NH was confirmed by pathology and histology, and the patient achieved a partial response (PR) by interim assessment after 3-4 courses of first-line chemotherapy; B-cell non-Hodgkin lymphoma mainly includes the following two types: (1) Diffuse large B-cell lymphoma (DLBCL); Mantle cell lymphoma (MCL); 5. Measurable or evaluable lesions; 6. The patient's main tissues and organs function well: Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L; Renal function: creatinine < 220μmol/L; Lung function: indoor oxygen saturation ≥95%; Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. 7. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion; 8. Patients with ECOG score ≤2 and expected survival time ≥3 months. Exclusion Criteria: Women who are pregnant (urine/blood pregnancy test positive) or breastfeeding; Men or women who have planned to become pregnant within the last 1 year; The patients were not guaranteed to take effective contraceptive measures (condoms or contraceptives, etc.) within 1 year after enrollment; Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment; Active hepatitis B/C virus; Hiv-infected patients; Suffering from a serious autoimmune disease or immunodeficiency disease; The patient is allergic to antibodies, cytokines and other macromolecular biological drugs; The patient had participated in other clinical trials within 6 weeks prior to enrollment; Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones); Suffers from mental illness; The patient has substance abuse/addiction; According to the researchers' judgment, the patient had other conditions that were not suitable for inclusion.

Sites / Locations

  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASCT+CAR-T Cell Infusion

Arm Description

CD19 CAR-T cells were prepared from peripheral lymphocytes of NHL patients with PR after 3 to 4 courses of chemotherapy, and autologous stem cells were collected and frozen after mobilization of patient stem cells by granulocyte stimulating factor (10μg/kg/d*5d). BEAM pretreatment was performed. Autologous stem cells were injected 24 h after pretreatment, and the number of CD34+ cells was > 2*106/kg. On the 6th day after transplantation, autologous Anti-CD19 CAR T cells were transfused, and the dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. The patients were given constant intravenous drip/push infusion for 30 minutes.

Outcomes

Primary Outcome Measures

Complete response rate
Proportion of enrolled patients who achieved complete response after treatment

Secondary Outcome Measures

overall survival
The time interval between patient infusion of CAR-T and death from any cause or the end of follow-up.
Progression-free survival
The time between treatment and observation of disease progression or death from any cause.

Full Information

First Posted
February 23, 2023
Last Updated
February 23, 2023
Sponsor
The Affiliated Hospital of Xuzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05755828
Brief Title
Clinical Study of Autologous Stem Cell Transplantation + Anti-CD19 CAR T Cells for B-cell Lymphoma
Official Title
Prospective, Multicenter, Open, One-arm Clinical Study of Safety and Efficacy of Autologous Stem Cell Transplantation + Anti-CD19 CAR T Cells for B-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
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
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the CR rate of B-NHL subjects who achieved PR at intermediate assessment after first-line chemotherapy treated with autologous stem cell transplantation + Anti-CD19 CAR T cells.
Detailed Description
At present, the incidence of malignant hematological diseases represented by leukemia, lymphoma and multiple myeloma is increasing year by year, ranking in the top ten of tumor incidence and mortality, which greatly endangers people's health and social development . B-cell non-Hodgkin's lymphoma (NHL) is a common aggressive malignant lymphoma. Poor response of some patients to traditional first-line chemotherapy is one of the major problems facing this disease. As a result, researchers are using emerging tools such as high-throughput sequencing to further understand the nature of the disease, refine the classification of the disease, and on this basis develop personalized treatments to improve the prognosis of the disease. Lymphoma has a complex immunosuppressive microenvironment that may prevent CAR T from achieving sustained precision tumor killing. As a revolutionary immunotherapy strategy, CAR-T therapy is currently faced with some bottleneck problems such as post-treatment relapse (including antigen loss relapse and antigen positive relapse), CAR-T consumption, off-target effect and so on. At present, autologous stem cell transplantation still plays a pivotal role in high-risk B-NHL. But at the same time, autologous stem cell transplantation is also faced with the age of patients, the influence of minimal residual disease (MRD) status before transplantation, chemotherapy dependence sensitivity, post-transplantation recurrence, post-transplantation granulosis infection and other problems. In this study, we explored the efficacy and safety of autologous stem cell transplantation combined with Anti-CD19 CAR-T cells in the treatment of B-cell NHL in patients with B-NHL who achieved partial response (PR) in the interim assessment after 3-4 courses of first-line therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Lymphoma
Keywords
Anti-CD19 CAR-T, Autologous stem cell transplantation, Combination therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ASCT+CAR-T Cell Infusion
Arm Type
Experimental
Arm Description
CD19 CAR-T cells were prepared from peripheral lymphocytes of NHL patients with PR after 3 to 4 courses of chemotherapy, and autologous stem cells were collected and frozen after mobilization of patient stem cells by granulocyte stimulating factor (10μg/kg/d*5d). BEAM pretreatment was performed. Autologous stem cells were injected 24 h after pretreatment, and the number of CD34+ cells was > 2*106/kg. On the 6th day after transplantation, autologous Anti-CD19 CAR T cells were transfused, and the dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. The patients were given constant intravenous drip/push infusion for 30 minutes.
Intervention Type
Biological
Intervention Name(s)
ASCT+CAR-T Cell Infusion
Intervention Description
CD19 CAR-T cells were prepared from peripheral lymphocytes of NHL patients with PR after 3 to 4 courses of chemotherapy, and autologous stem cells were collected and frozen after mobilization of patient stem cells by granulocyte stimulating factor (10μg/kg/d*5d). BEAM pretreatment was performed. Autologous stem cells were injected 24 h after pretreatment, and the number of CD34+ cells was > 2*106/kg. On the 6th day after transplantation, autologous Anti-CD19 CAR T cells were transfused, and the dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. The patients were given constant intravenous drip/push infusion for 30 minutes.
Primary Outcome Measure Information:
Title
Complete response rate
Description
Proportion of enrolled patients who achieved complete response after treatment
Time Frame
From 3 months to 1 year.
Secondary Outcome Measure Information:
Title
overall survival
Description
The time interval between patient infusion of CAR-T and death from any cause or the end of follow-up.
Time Frame
From 3 months to 1 year.
Title
Progression-free survival
Description
The time between treatment and observation of disease progression or death from any cause.
Time Frame
From 3 months to 1 year.

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: Patients or their legal guardians voluntarily participate and sign the informed consent; Male or female patients aged 18-70 years (including 18 and 70 years); CD19+ B-NH was confirmed by pathology and histology, and the patient achieved a partial response (PR) by interim assessment after 3-4 courses of first-line chemotherapy; B-cell non-Hodgkin lymphoma mainly includes the following two types: (1) Diffuse large B-cell lymphoma (DLBCL); Mantle cell lymphoma (MCL); 5. Measurable or evaluable lesions; 6. The patient's main tissues and organs function well: Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L; Renal function: creatinine < 220μmol/L; Lung function: indoor oxygen saturation ≥95%; Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. 7. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion; 8. Patients with ECOG score ≤2 and expected survival time ≥3 months. Exclusion Criteria: Women who are pregnant (urine/blood pregnancy test positive) or breastfeeding; Men or women who have planned to become pregnant within the last 1 year; The patients were not guaranteed to take effective contraceptive measures (condoms or contraceptives, etc.) within 1 year after enrollment; Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment; Active hepatitis B/C virus; Hiv-infected patients; Suffering from a serious autoimmune disease or immunodeficiency disease; The patient is allergic to antibodies, cytokines and other macromolecular biological drugs; The patient had participated in other clinical trials within 6 weeks prior to enrollment; Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones); Suffers from mental illness; The patient has substance abuse/addiction; According to the researchers' judgment, the patient had other conditions that were not suitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Sang, M.D., Ph.D.
Phone
13645207648
Email
xyfylbl515@xzhmu.edu.cn
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Sang, M.D., Ph.D.
Phone
13645207648
Email
xyfylbl515@xzhmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study of Autologous Stem Cell Transplantation + Anti-CD19 CAR T Cells for B-cell Lymphoma

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