Clinical Trial for the Safety and Efficacy of Anti-CD7 CAR-T Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy

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: CD7+ Acute Leukemia; CD7+ Lymphoma
• Intervention / Treatment: Biological: anti-CD7 CAR-T

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yongxian Hu; Phone Number: +86-0571-87236476; Email: huyongxian2000@aliyun.com

Study Locations

• China
  • 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

Eligibility Criteria

• Ages Eligible for Study: 8 months to 76 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Total bilirubin ≤ 51 μmol / L, ALT and AST ≤ 3 times of the upper limit of normal value, serum creatinine ≤ 176.8 μmol / L;
2. Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
3. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
4. The estimated survival time is more than 3 months;
5. ECOG score was 0-2;
6. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.

For T-ALL/LBL:

1. 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).

2. The diagnosis is consistent with r/r CD7 + T-ALL/LBL, and includes any of the following conditions:

   1. No CR was obtained by standard chemotherapy;
   2. The first induction was CR, but the duration of CR was less than 12 months;
   3. No CR was obtained after the first or multiple remedial treatment;
   4. Relapse twice or more;
3. The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).

For T-NHL:

1. Patients is histologically diagnosed with CD7 Positive T-NHL according to The 2016 revision of the World Health Organization classification of lymphoid neoplasms.

2. r/r T-NHL, and includes any of the following conditions:

   1. No response or relapse after second or more lines of chemotherapy;
   2. Primary refractory ot chemotherapy;
   3. Relapse after autologous stem cell transplantation;
3. According to the Lugano 2014 criteria, there is at least one evaluable tumor lesion.

For AML:

1. 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).

2. The diagnosis is consistent with r/r CD7 + AML, and includes any of the following conditions:

   1. No CR was obtained by standard chemotherapy;
   2. The first induction was CR, but the duration of CR was less than 12 months;
   3. No CR was obtained after the first or multiple remedial treatment;
   4. Relapse twice or more;
3. The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry).

Exclusion Criteria:

1. Patients with history of epilepsy or other central nervous system diseases;
2. Patients with prolonged QT or severe heart disease;
3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
4. The patients with uncontrolled active infection;
5. Active hepatitis B or hepatitis C virus infection;
6. Previous application of gene therapy;
7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
8. Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
9. Those who suffer from other uncontrolled diseases are not suitable to join the study;
10. HIV infection;
11. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-NHL	Biological: anti-CD7 CAR-T; Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion
Experimental: AML	Biological: anti-CD7 CAR-T; Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion
Experimental: T-ALL/LBL	Biological: anti-CD7 CAR-T; Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose limiting toxicity	28 days
Treatment Emergent Adverse Event	2 years

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Yake Biotechnology Ltd.

Study record dates

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: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• 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