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Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

Primary Purpose

B-cell Adult Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Adult Acute Lymphoblastic Leukemia in Remission

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
anti-CD19 CAR-T
Fludarabine
Cyclophosphamide
Sponsored by
First Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Adult Acute Lymphoblastic Leukemia

Eligibility Criteria

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

Inclusion Criteria:

  • 5 Years to 70 Years, Male and female;
  • Expected survival > 12 weeks;
  • Performance score 0-2;
  • Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
  • Creatinine < 2.5 mg/dl;
  • ALT/AST < 3x normal;
  • Bilirubin < 2.0 mg/dl;
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis;
  • Take contraceptive measures before recruit to this trial;
  • Written voluntary informed consent is given.

Exclusion Criteria:

  • Patients with symptoms of central nervous system
  • Accompanied by other malignant tumor
  • Active hepatitis B or C, HIV infection
  • Any other diseases could affect the outcome of this trial
  • Suffering severe cardiovascular or respiratory disease
  • Poorly controlled hypertension
  • A history of mental illness and poorly controlled
  • Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
  • Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
  • Reaching a steady dose if receiving anticoagulant therapy before assignment
  • Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
  • Pregnant or lactating women
  • Subject suffering disease affects the understanding of informed consent or comply with study protocol.

Sites / Locations

  • The First Affilicated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD9CAR-T transfer

Arm Description

All subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T

Outcomes

Primary Outcome Measures

Safety - incidence of adverse events defined as dose-limited toxicity
incidence of adverse events defined as dose-limited toxicity

Secondary Outcome Measures

Overall complete remission rate
Overall complete remission rate
Duration of remission
Duration of remission

Full Information

First Posted
April 6, 2017
Last Updated
November 25, 2019
Sponsor
First Affiliated Hospital of Wenzhou Medical University
Collaborators
Hrain Biotechnology Co., Ltd., Second Affiliated Hospital of Nanchang University
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1. Study Identification

Unique Protocol Identification Number
NCT03110640
Brief Title
Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma
Official Title
A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Wenzhou Medical University
Collaborators
Hrain Biotechnology Co., Ltd., Second Affiliated Hospital of Nanchang University

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
This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.
Detailed Description
Primary objectives To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Adult Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Hematopoietic/Lymphoid Cancer, Refractory Chronic Lymphocytic 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
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CD9CAR-T transfer
Arm Type
Experimental
Arm Description
All subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T
Intervention Type
Biological
Intervention Name(s)
anti-CD19 CAR-T
Intervention Description
Ex vivo-expanded autologous T cells modified to express CD19 CAR
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Patients were given cyclophosphamide 500mg/m2/day on day -4 and fludarabine at 25 mg/m2/day on day -4, day -3, and day -2.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Patients were given cyclophosphamide 500mg/m2/day on day -4.
Primary Outcome Measure Information:
Title
Safety - incidence of adverse events defined as dose-limited toxicity
Description
incidence of adverse events defined as dose-limited toxicity
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Overall complete remission rate
Description
Overall complete remission rate
Time Frame
1 year
Title
Duration of remission
Description
Duration of remission
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 5 Years to 70 Years, Male and female; Expected survival > 12 weeks; Performance score 0-2; Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy Creatinine < 2.5 mg/dl; ALT/AST < 3x normal; Bilirubin < 2.0 mg/dl; Adequate venous access for apheresis, and no other contraindications for leukapheresis; Take contraceptive measures before recruit to this trial; Written voluntary informed consent is given. Exclusion Criteria: Patients with symptoms of central nervous system Accompanied by other malignant tumor Active hepatitis B or C, HIV infection Any other diseases could affect the outcome of this trial Suffering severe cardiovascular or respiratory disease Poorly controlled hypertension A history of mental illness and poorly controlled Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment Reaching a steady dose if receiving anticoagulant therapy before assignment Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion Pregnant or lactating women Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kang Yu, M.D.
Phone
55578037
Email
yukang62@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang Yu, M.D.
Organizational Affiliation
First Affiliated Hospital of Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affilicated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kang Yu, M.D
Phone
55578037
Email
yukang62@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34935483
Citation
Dong R, Jiang S, Chen Y, Ma Y, Sun L, Xing C, Zhang S, Yu K. Prognostic Significance of Cytokine Release Syndrome in B Cell Hematological Malignancies Patients After Chimeric Antigen Receptor T Cell Therapy. J Interferon Cytokine Res. 2021 Dec;41(12):469-476. doi: 10.1089/jir.2021.0057.
Results Reference
derived

Learn more about this trial

Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

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