- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04599556
Clinical Trial for the Safety and Efficacy of Anti-CD7 CAR-T Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy
November 29, 2023 updated by: He Huang, Zhejiang University
Clinical Trial for the Safety and Efficacy of Anti-CD7 Chimeric Antigen Receptor Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy
This is a prospective, open-label, single-center clinical trial.
This study will evaluate the safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7 positive T-ALL/LBL, T-NHL and AML.
The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
81
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yongxian Hu
- Phone Number: +86-0571-87236476
- Email: huyongxian2000@aliyun.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- Recruiting
- The First Affiliated Hospital,College of Medicine, Zhejiang University
-
Contact:
- He Huang, PhD
- Phone Number: 86-13605714822
- Email: hehuangyu@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 78 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Total bilirubin ≤ 51 μmol / L, ALT and AST ≤ 3 times of the upper limit of normal value, serum creatinine ≤ 176.8 μmol / L;
- Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
- There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
- The estimated survival time is more than 3 months;
- ECOG score was 0-2;
- The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
For T-ALL/LBL:
- Patients is histologically diagnosed with CD7 Positive T-ALL/LBL according to the Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (ALL) (2020. V1) by National Comprehensive Cancer Network (NCCN).
The diagnosis is consistent with r/r CD7 + T-ALL/LBL, and includes any of the following conditions:
- No CR was obtained by standard chemotherapy;
- The first induction was CR, but the duration of CR was less than 12 months;
- No CR was obtained after the first or multiple remedial treatment;
- Relapse twice or more;
- The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).
For T-NHL:
- Patients is histologically diagnosed with CD7 Positive T-NHL according to The 2016 revision of the World Health Organization classification of lymphoid neoplasms.
r/r T-NHL, and includes any of the following conditions:
- No response or relapse after second or more lines of chemotherapy;
- Primary refractory ot chemotherapy;
- Relapse after autologous stem cell transplantation;
- According to the Lugano 2014 criteria, there is at least one evaluable tumor lesion.
For AML:
- Patients is histologically diagnosed with CD7 Positive AML according to the Clinical Practice Guidelines for Acute Myeloid Leukemia (AML) (2020. V3) by National Comprehensive Cancer Network (NCCN).
The diagnosis is consistent with r/r CD7 + AML, and includes any of the following conditions:
- No CR was obtained by standard chemotherapy;
- The first induction was CR, but the duration of CR was less than 12 months;
- No CR was obtained after the first or multiple remedial treatment;
- Relapse twice or more;
- The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).
Exclusion Criteria:
- Patients with history of epilepsy or other central nervous system diseases;
- Patients with prolonged QT or severe heart disease;
- Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
- The patients with uncontrolled active infection;
- Active hepatitis B or hepatitis C virus infection;
- Previous application of gene therapy;
- The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- Those who suffer from other uncontrolled diseases are not suitable to join the study;
- HIV infection;
- Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: T-NHL
|
Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion
|
Experimental: AML
|
Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion
|
Experimental: T-ALL/LBL
|
Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose limiting toxicity
Time Frame: 28 days
|
28 days
|
Treatment Emergent Adverse Event
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Estimated)
December 30, 2023
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
October 21, 2020
First Submitted That Met QC Criteria
October 21, 2020
First Posted (Actual)
October 22, 2020
Study Record Updates
Last Update Posted (Estimated)
December 6, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD7-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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