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Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia

Primary Purpose

T Lymphoblastic Leukemia/Lymphoma, Mixed Phenotype Acute Leukemia, Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Humanized CD7 CAR-T cells
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T Lymphoblastic Leukemia/Lymphoma focused on measuring CD7 Positive, CAR-T

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed CD7 positive relapsed/refractory acute leukemia.
  2. Age 12-65 years.
  3. Eastern Cooperative Oncology Group (ECOG) score 0-2.
  4. CD7 on leukemia is >30% positive detected with flow cytometry.
  5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
  6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.

Exclusion Criteria:

  1. Patients are pregnant or lactating
  2. Patients with congenital immunodeficiency.
  3. Patients with central nervous system leukemia.
  4. Patients with uncontrolled active infection.
  5. Patients with active hepatitis B or hepatitis C infection.
  6. Patients with HIV infection.
  7. Patients with atrial or venous thrombosis or embolism.
  8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
  9. Other comorbidities that investigators considered not suitable for this study.

Sites / Locations

  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD38 positive relapsed or refractory acute leukemia

Arm Description

Biological/Vaccine: Humanized CD7 CAR-T cells Split intravenous infusion of CD7 CAR-T cells [dose escalating infusion of (0.5- 10)x10^6 CD7 CAR-T cells/kg

Outcomes

Primary Outcome Measures

Number of Adverse Events
Adverse events are evaluated with CTCAE V5.0

Secondary Outcome Measures

Overall response rate (ORR)
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Cumulative incidence of relapse(CIR)
time from the date of achievement of a remission until the date of relapse.
the duration of CAR T-cells in vivo
the time of CAR-T cells' persistence in blood and the copies of CAR-T cells

Full Information

First Posted
February 8, 2021
Last Updated
June 1, 2021
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04762485
Brief Title
Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia
Official Title
Humanized Chimeric Antigen Receptor T Cells Against CD7 for Refractory/Relapsed CD7+ Acute Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive acute leukemia.
Detailed Description
The patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory acute leukemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Lymphoblastic Leukemia/Lymphoma, Mixed Phenotype Acute Leukemia, Acute Myeloid Leukemia
Keywords
CD7 Positive, CAR-T

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CD38 positive relapsed or refractory acute leukemia
Arm Type
Experimental
Arm Description
Biological/Vaccine: Humanized CD7 CAR-T cells Split intravenous infusion of CD7 CAR-T cells [dose escalating infusion of (0.5- 10)x10^6 CD7 CAR-T cells/kg
Intervention Type
Biological
Intervention Name(s)
Humanized CD7 CAR-T cells
Intervention Description
Split intravenous infusion of CD7 CAR-T cells [dose escalating infusion of (0.5-10)x10^6 CD7 CAR-T cells/kg
Primary Outcome Measure Information:
Title
Number of Adverse Events
Description
Adverse events are evaluated with CTCAE V5.0
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Time Frame
2 years
Title
Cumulative incidence of relapse(CIR)
Description
time from the date of achievement of a remission until the date of relapse.
Time Frame
2 years
Title
the duration of CAR T-cells in vivo
Description
the time of CAR-T cells' persistence in blood and the copies of CAR-T cells
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed CD7 positive relapsed/refractory acute leukemia. Age 12-65 years. Eastern Cooperative Oncology Group (ECOG) score 0-2. CD7 on leukemia is >30% positive detected with flow cytometry. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL. Exclusion Criteria: Patients are pregnant or lactating Patients with congenital immunodeficiency. Patients with central nervous system leukemia. Patients with uncontrolled active infection. Patients with active hepatitis B or hepatitis C infection. Patients with HIV infection. Patients with atrial or venous thrombosis or embolism. Patients with myo-infarction or severe arrythmia in the recent 6 months. Other comorbidities that investigators considered not suitable for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaowen tang, Ph.D
Phone
(0086)51267781856
Email
xwtang1020@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Yang, Ph.D
Phone
(0086)18896802149
Email
ylyh188@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaowen tang, Ph.D
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
(Select)
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaowen tang, phd
Phone
(0086)51267781856
Email
xwtang1020@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
36175988
Citation
Cao X, Dai H, Cui Q, Li Z, Shen W, Pan J, Shen H, Ma Q, Li M, Chen S, Chen J, Zhu X, Meng H, Yang L, Wu D, Tang X. CD7-directed CAR T-cell therapy: a potential immunotherapy strategy for relapsed/refractory acute myeloid leukemia. Exp Hematol Oncol. 2022 Sep 29;11(1):67. doi: 10.1186/s40164-022-00318-6.
Results Reference
derived

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Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia

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