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CD19 CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia

Primary Purpose

B Cell Lymphoma, B-cell Acute Lymphoblastic Leukemia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Anti-CD19 CAR-T Cells Injection
Sponsored by
Yan'an Affiliated Hospital of Kunming Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Cell Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients or their legal guardians voluntarily participate and sign the Informed Consent Document;
  2. 18 Years and older, Male and female;
  3. Pathologically and histologically confirmed CD19 + B cell tumors; Patients currently have no effective treatment options, such as chemotherapy or relapse after hematopoietic stem cell transplantation; Or patients voluntarily choose transfusion of anti-CD19 CAR-T cells as the first treatment program;

B-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types:

  1. B-cell acute lymphoblastic leukemia;
  2. Indolent B-cell lymphomas;
  3. Aggressive B-cell lymphoma; 4、 Subjects:

(1) Residual lesions remain after treatment; (2) Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (3) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (4) Patients with high risk factors; (5) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy.

5、 Have measurable or evaluable tumor foci; 6、 Liver, kidney and cardiopulmonary functions meet the following requirements:

  1. Serum glutamic pyruvic transaminase (ALT) and serum glutamic oxaloacetic transaminase (AST) <3 ×upper limit of normal (ULN);
  2. Total bilirubin ≤34.2μmol/L;
  3. Serum creatinine<220μmol/L;
  4. Baseline oxygen saturation≥95%;
  5. Left ventricular ejection fraction(LVEF)≥40%. 7、 Subjects who did not receive Chemotherapy, Radiotherapy, Immunotherapy (immunosuppressive drugs) or other treatment within 4 weeks prior to enrollment; Relevant toxicity≤1 grade before enrollment (except for low toxicity such as hair loss); 8、Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip; 9、Clinical performance status of eastern cancer cooperation group (ECOG) score ≤2,Expected survival≥3 months;

Exclusion Criteria:

  1. Pregnant (urine/blood pregnancy test positive) or lactating women;
  2. Planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion;
  3. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment;
  4. Active or uncontrollable infection within four weeks prior to enrollment;
  5. Patients with active hepatitis B/C;
  6. HIV-infected patients;
  7. Severe autoimmune or immunodeficiency disorders;
  8. Patients are allergic to macromolecule drugs such as antigens or cytokines;
  9. Subjects participated in other clinical trials within 6 weeks before enrollment;
  10. Systematic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);
  11. Mental illness;
  12. Drug abuse/addiction;
  13. The investigators consider other conditions unsuitable for enrollment.

Sites / Locations

  • Kunming Yan'an Hospital, Oncology DepartmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anti-CD19 CAR-T Cells Injection

Arm Description

Dosage form:injection Dosage:1-5x10^6/kg, 70ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes Frequency: total one time

Outcomes

Primary Outcome Measures

Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability.
The severe CRS post KD-019 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined.
Copies numbers of CAR in peripheral blood (PB)
Copies numbers of CAR in peripheral blood (PB)

Secondary Outcome Measures

Overall survival
For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason
Duration of Response after administration
Duration of Response after administration
Progress Free Survival after administration
Progress Free Survival after administration

Full Information

First Posted
February 20, 2019
Last Updated
February 25, 2019
Sponsor
Yan'an Affiliated Hospital of Kunming Medical University
Collaborators
KAEDI
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1. Study Identification

Unique Protocol Identification Number
NCT03854994
Brief Title
CD19 CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia
Official Title
A Phase I Clinical Trial of Anti-CD19 Chimeric Antigen Receptor With Synthetic Biology Optimizing Nano-vector T Cells Injection for Subjects With Relapsed/Refractory/High-risk B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yan'an Affiliated Hospital of Kunming Medical University
Collaborators
KAEDI

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
The primary objective of this study is to evaluate the safety and clinical activity of anti-CD19 Chimeric Antigen Receptor T cells (KD-019 CAR-T)infusion in the treatment of relapsed/refractory B-cell Lymphoma and B-cell acute lymphoblastic leukemia (B-ALL).
Detailed Description
The investigators designed an KD-019 Chimeric Antigen Receptor(CAR) with FMC63 single-chain antibody fragment (Scfv). This CAR has a CD8 hinge and transmembrane domains and a 4-1BB costimulatory domain; T cells expressing this CAR release relatively low levels of cytokines. Subjects with relapsed/refractory CD19-positive B-cell Lymphoma and B-ALL can participate if all eligibility criteria are met. Subjects receive chemotherapy prior to the infusion of KD-019 CAR-T cells. After the infusion, subjects will accept follow-up for side effects and effect of KD-019 CAR-T cells by the sponsor. Study procedures may be performed while hospitalized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Lymphoma, B-cell Acute Lymphoblastic Leukemia

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
Anti-CD19 CAR-T Cells Injection
Arm Type
Experimental
Arm Description
Dosage form:injection Dosage:1-5x10^6/kg, 70ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes Frequency: total one time
Intervention Type
Biological
Intervention Name(s)
Anti-CD19 CAR-T Cells Injection
Other Intervention Name(s)
KD-019 CAR-T cells Injection
Intervention Description
Autologous genetically modified anti-CD19 CAR transduced T cells
Primary Outcome Measure Information:
Title
Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability.
Description
The severe CRS post KD-019 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined.
Time Frame
0 to 14 days post infusion
Title
Copies numbers of CAR in peripheral blood (PB)
Description
Copies numbers of CAR in peripheral blood (PB)
Time Frame
1 year post infusion
Secondary Outcome Measure Information:
Title
Overall survival
Description
For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason
Time Frame
2 years post infusion
Title
Duration of Response after administration
Description
Duration of Response after administration
Time Frame
2 years post infusion
Title
Progress Free Survival after administration
Description
Progress Free Survival after administration
Time Frame
2 years post infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients or their legal guardians voluntarily participate and sign the Informed Consent Document; 18 Years and older, Male and female; Pathologically and histologically confirmed CD19 + B cell tumors; Patients currently have no effective treatment options, such as chemotherapy or relapse after hematopoietic stem cell transplantation; Or patients voluntarily choose transfusion of anti-CD19 CAR-T cells as the first treatment program; B-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types: B-cell acute lymphoblastic leukemia; Indolent B-cell lymphomas; Aggressive B-cell lymphoma; 4、 Subjects: (1) Residual lesions remain after treatment; (2) Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (3) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (4) Patients with high risk factors; (5) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy. 5、 Have measurable or evaluable tumor foci; 6、 Liver, kidney and cardiopulmonary functions meet the following requirements: Serum glutamic pyruvic transaminase (ALT) and serum glutamic oxaloacetic transaminase (AST) <3 ×upper limit of normal (ULN); Total bilirubin ≤34.2μmol/L; Serum creatinine<220μmol/L; Baseline oxygen saturation≥95%; Left ventricular ejection fraction(LVEF)≥40%. 7、 Subjects who did not receive Chemotherapy, Radiotherapy, Immunotherapy (immunosuppressive drugs) or other treatment within 4 weeks prior to enrollment; Relevant toxicity≤1 grade before enrollment (except for low toxicity such as hair loss); 8、Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip; 9、Clinical performance status of eastern cancer cooperation group (ECOG) score ≤2,Expected survival≥3 months; Exclusion Criteria: Pregnant (urine/blood pregnancy test positive) or lactating women; Planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion; Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment; Active or uncontrollable infection within four weeks prior to enrollment; Patients with active hepatitis B/C; HIV-infected patients; Severe autoimmune or immunodeficiency disorders; Patients are allergic to macromolecule drugs such as antigens or cytokines; Subjects participated in other clinical trials within 6 weeks before enrollment; Systematic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones); Mental illness; Drug abuse/addiction; The investigators consider other conditions unsuitable for enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peixian Zhang
Phone
86-0871-63211268
Email
px29@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peixian Zhang
Organizational Affiliation
Kunming Yan'an Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kunming Yan'an Hospital, Oncology Department
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Shi
Phone
86-18988158897
Email
shi_lanlan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jiabao Song
Phone
86-15663656065
Email
jiabaosong668@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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CD19 CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia

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