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CD7 CAR-T Cells in T-cell Lymphoma/Leukemia

Primary Purpose

T Lymphoblastic Leukemia/Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CD7 CAR-T cells
Sponsored by
Shenzhen University General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T Lymphoblastic Leukemia/Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited; The subject voluntarily participates in the research and signs the "Informed Consent" by himself or his legal guardian; According to the National Comprehensive Cancer Network (NCCN) T lymphocytic lymphoma (2020.V1)/acute lymphoblastic leukemia (2020. V1) practice guidelines, diagnosed with T-cell lymphoma; Meet the diagnostic criteria for relapsed/refractory T-cell lymphoma, including any of the following: 1) Failure to obtain CR at the end of induction therapy; 2) Patients who have obtained CR have blasts in peripheral blood or bone marrow (proportion >5%), or extramedullary diseases; 5. Have not received antibody therapy within 2 weeks before cell therapy; 6. ECOG score of 0-2; 7. The subject has no contraindications to peripheral apheresis; 8. Expected survival time of more than 3 months. Exclusion Criteria: Those who have a history of allergy to any of the ingredients in cell products; Laboratory tests for the following: including but not limited to, total serum bilirubin≧ 1.5mg/dl; Serum ALT or AST greater than 2.5 times the upper limit of normal; Blood creatinine≧ 2.0mg/dl; Platelet count≦ 10×109/L; Patients with cardiac insufficiency who belong to class III or IV according to the New York Cardiology Association (NYHA) cardiac function grading standards; or echocardiography with left ventricular ejection fraction (LVEF) < 50%; Abnormal lung function, blood oxygen saturation under indoor air < 92%; Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other serious clinical heart disease within 12 months before enrollment; Grade 3 hypertension with poor control of blood pressure with medication; Patients with other advanced tumors (those who are assessed as stable after treatment of other tumors can be enrolled); Previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease; Known central nervous system leukemia (CNS2 or CNS3), resistance to intrathecal chemotherapy injections and/or ongoing head and/or spinal radiation therapy; Previous CNS history but has been effectively controlled to allow enrollment; Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressant therapy; presence of uncontrolled, active infection; Have previously used any CAR-T cell product or other genetically modified T cell therapy; Live vaccination within 4 weeks prior to enrollment; HIV, HBV, HCV and TPPA/RPR infections, and HBV carriers; Subject has a history of alcoholism, drug addiction or mental illness; The subject has participated in any other clinical research within 3 months before joining this clinical study; Female subjects have any of the following conditions: a) are pregnant/lactating; or b) have plans to become pregnant during the trial; or c) are of childbearing potential and unable to use effective contraception; There are other circumstances in which the investigator believes that the subject is not suitable for this study.

Sites / Locations

  • Li YuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

CD7 CAR-T treatment group

Outcomes

Primary Outcome Measures

TEAEs
Adverse events during treatment

Secondary Outcome Measures

overall response rate
the proportion of complete and partial response patients

Full Information

First Posted
November 11, 2022
Last Updated
November 11, 2022
Sponsor
Shenzhen University General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05620680
Brief Title
CD7 CAR-T Cells in T-cell Lymphoma/Leukemia
Official Title
Study of CD7 CAR-T Cells in Adult Refractory and Recurrent T-cell Lymphoma/Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 31, 2026 (Anticipated)
Study Completion Date
October 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen University General Hospital

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
T-cell lymphoma/leukemia is a group of highly lethal diseases with a high relapse rate and poor prognosis. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target. In this study we aim to test the safety and efficacy of CD7 CAR-T cells in T-cell lymphoma/leukemia.
Detailed Description
T-cell lymphoma accounts for 10%~15% of non-Hodgkin lymphoma in China. According to the World Health Organization (WHO), T-cell lymphoma was divided into the following subtypes: T-cell, NK cell lymphoma/leukemia. There were two major categories: anterior T-cell tumors and posterior thymic T-cell lymphomas, which originate from lymph nodes, extranodal tissue, or skin; mature or peripheral T-cell lymphomas. Generally speaking, the relapse accounts for 50-60% after first-line treatment, while the remission rate with second-line treatment was extremely low. Collectively, there was an urgent need for new treatment modalities to improve the clinical outcomes of these patients. CD7 is a transmembrane glycoprotein that plays an important role in T-cell and T-cell/B-cell interactions during early lymphoid development. The expression of CD7 persist from stem to mature T cells. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target. In this study we aim to testify the safy and efficacy of CD7 CAR-T cells in T-cell lymphoma/leukemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Lymphoblastic Leukemia/Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
CD7 CAR-T treatment group
Intervention Type
Biological
Intervention Name(s)
CD7 CAR-T cells
Intervention Description
patient was subjected to 0.5-2×10^6 cells/kg of CD7 CAR- T
Primary Outcome Measure Information:
Title
TEAEs
Description
Adverse events during treatment
Time Frame
From date of initial treatment to the 30 days after treatment
Secondary Outcome Measure Information:
Title
overall response rate
Description
the proportion of complete and partial response patients
Time Frame
baseline and 8 weeks, up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited; The subject voluntarily participates in the research and signs the "Informed Consent" by himself or his legal guardian; According to the National Comprehensive Cancer Network (NCCN) T lymphocytic lymphoma (2020.V1)/acute lymphoblastic leukemia (2020. V1) practice guidelines, diagnosed with T-cell lymphoma; Meet the diagnostic criteria for relapsed/refractory T-cell lymphoma, including any of the following: 1) Failure to obtain CR at the end of induction therapy; 2) Patients who have obtained CR have blasts in peripheral blood or bone marrow (proportion >5%), or extramedullary diseases; 5. Have not received antibody therapy within 2 weeks before cell therapy; 6. ECOG score of 0-2; 7. The subject has no contraindications to peripheral apheresis; 8. Expected survival time of more than 3 months. Exclusion Criteria: Those who have a history of allergy to any of the ingredients in cell products; Laboratory tests for the following: including but not limited to, total serum bilirubin≧ 1.5mg/dl; Serum ALT or AST greater than 2.5 times the upper limit of normal; Blood creatinine≧ 2.0mg/dl; Platelet count≦ 10×109/L; Patients with cardiac insufficiency who belong to class III or IV according to the New York Cardiology Association (NYHA) cardiac function grading standards; or echocardiography with left ventricular ejection fraction (LVEF) < 50%; Abnormal lung function, blood oxygen saturation under indoor air < 92%; Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other serious clinical heart disease within 12 months before enrollment; Grade 3 hypertension with poor control of blood pressure with medication; Patients with other advanced tumors (those who are assessed as stable after treatment of other tumors can be enrolled); Previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease; Known central nervous system leukemia (CNS2 or CNS3), resistance to intrathecal chemotherapy injections and/or ongoing head and/or spinal radiation therapy; Previous CNS history but has been effectively controlled to allow enrollment; Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressant therapy; presence of uncontrolled, active infection; Have previously used any CAR-T cell product or other genetically modified T cell therapy; Live vaccination within 4 weeks prior to enrollment; HIV, HBV, HCV and TPPA/RPR infections, and HBV carriers; Subject has a history of alcoholism, drug addiction or mental illness; The subject has participated in any other clinical research within 3 months before joining this clinical study; Female subjects have any of the following conditions: a) are pregnant/lactating; or b) have plans to become pregnant during the trial; or c) are of childbearing potential and unable to use effective contraception; There are other circumstances in which the investigator believes that the subject is not suitable for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Li, Dr
Phone
+8675521839178
Email
liyu@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yu, Dr
Organizational Affiliation
Shenzhen University General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li Yu
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yu
Phone
+8675521839178
Email
liyu@vip.163.com

12. IPD Sharing Statement

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CD7 CAR-T Cells in T-cell Lymphoma/Leukemia

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