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Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells

Primary Purpose

B-cell Non Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
regimen with BTK inhibitor +Anti-CD19 CAR T cells
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 Non Hodgkin Lymphoma focused on measuring BTK inhibitor, Anti CD19 CAR-T cells

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 old; CD19+ B-NHL was confirmed by pathology and histology, and the patient had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Or patients voluntarily chose BTKi+Anti-CD19 CAR T as salvage therapy; Subjects showed residual lesions after major treatment and were not suitable for HSCT; Relapse occurs after CR and is not suitable for HSCT; Patients with high risk factors; Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy; Have measurable or evaluable lesions; The patient's main tissues and organs function well; The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous drip. Patients with ECOG score ≤2, estimated survival time ≥3 months, age ≥ 12 years, ≤ 75 years. Exclusion Criteria: Women who are pregnant (urine/blood pregnancy test is positive) or breastfeeding; Men or women who have planned to get pregnant within the last 1 year; The patients were not guaranteed to take effective contraceptive measures (condom or contraceptive, 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); Suffering 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

CAR-T Cell Infusion

Arm Description

After FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd.

Outcomes

Primary Outcome Measures

objective response rate
CR+PR

Secondary Outcome Measures

Percentage of complete response
Percentage of complete response
Progression-free survival
The time between treatment and observation of disease progression or death from any cause.
Duration of response
Duration of response

Full Information

First Posted
February 14, 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
NCT05744037
Brief Title
Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells
Official Title
Prospective, Multicenter, Open, One-arm Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (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 ORR (CR+PR) of R/R B-NHL subjects treated with BTKi+Anti-CD19 CAR T cells.
Detailed Description
The most successful application of CAR-T cell technology in clinical practice is for the treatment of hematologic malignancies, which may be related to the strong specificity of tumor-associated antigen and the weak immunosuppressive effect of tumor microenvironment. CD19 is specifically expressed in B cells and is expressed in all stages of B-cell development and differentiation and in most B-cell tumors, but not in hematopoietic stem cells and other cells. CD19 is a promising target for B-cell tumors and is currently a hot spot in CAR studies. Antigen-dependent BCR signaling is involved in several downstream pathways, including NF-kB pathway and PI3K/AKT/mTOR pathway, which can promote B cell survival. BTK inhibitors can jointly inhibit the survival of tumor cells by promoting apoptosis and inhibiting the proliferation of tumor cells, reducing the adhesion of tumor cells, and inhibiting chemokines to prevent the migration of B cells. In this study, BTKi (Ibrutinib) combined with Anti-CD19 CAR-T cells were proposed to treat RR B-NHL, with the main purpose of observing the efficacy and safety of this regimen in patients with relapsed and refractory B-NHL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Non Hodgkin Lymphoma
Keywords
BTK inhibitor, Anti CD19 CAR-T cells

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
CAR-T Cell Infusion
Arm Type
Experimental
Arm Description
After FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd.
Intervention Type
Biological
Intervention Name(s)
regimen with BTK inhibitor +Anti-CD19 CAR T cells
Intervention Description
After FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd.
Primary Outcome Measure Information:
Title
objective response rate
Description
CR+PR
Time Frame
From 1 month to 1 year.
Secondary Outcome Measure Information:
Title
Percentage of complete response
Description
Percentage of complete response
Time Frame
From 1 month 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 1 month to 1 year.
Title
Duration of response
Description
Duration of response
Time Frame
From 1 month 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 old; CD19+ B-NHL was confirmed by pathology and histology, and the patient had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Or patients voluntarily chose BTKi+Anti-CD19 CAR T as salvage therapy; Subjects showed residual lesions after major treatment and were not suitable for HSCT; Relapse occurs after CR and is not suitable for HSCT; Patients with high risk factors; Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy; Have measurable or evaluable lesions; The patient's main tissues and organs function well; The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous drip. Patients with ECOG score ≤2, estimated survival time ≥3 months, age ≥ 12 years, ≤ 75 years. Exclusion Criteria: Women who are pregnant (urine/blood pregnancy test is positive) or breastfeeding; Men or women who have planned to get pregnant within the last 1 year; The patients were not guaranteed to take effective contraceptive measures (condom or contraceptive, 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); Suffering 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.
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 the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells

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