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

NCT ID: NCT04599556

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-12-30

Brief Summary

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).

Conditions

CD7+ Acute Leukemia; CD7+ Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

T-ALL/LBL

Group Type: EXPERIMENTAL

anti-CD7 CAR-T

Intervention Type: BIOLOGICAL

Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion

T-NHL

Group Type: EXPERIMENTAL

anti-CD7 CAR-T

Intervention Type: BIOLOGICAL

Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion

AML

Group Type: EXPERIMENTAL

anti-CD7 CAR-T

Intervention Type: BIOLOGICAL

Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion

Interventions

anti-CD7 CAR-T

Lymphodepleting chemotherapy followed by anti-CD7 CAR-T infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

The President of The First Affiliated Hospital, College of Medicine, Zhejiang University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital，College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongxian Hu

Role: CONTACT

Phone: +86-0571-87236476

Email: huyongxian2000@aliyun.com

Facility Contacts

He Huang, PhD

Role: primary

References

Hu Y, Zhang M, Yang T, Mo Z, Wei G, Jing R, Zhao H, Chen R, Zu C, Gu T, Xiao P, Hong R, Feng J, Fu S, Kong D, Xu H, Cui J, Huang S, Liang B, Yuan X, Cui Q, Guo H, Yu Y, Feng Y, Jin C, Ren J, Chang AH, Wang D, Huang H. Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis. N Engl J Med. 2024 Apr 25;390(16):1467-1480. doi: 10.1056/NEJMoa2313812.

Reference Type: DERIVED

PMID: 38657244 (View on PubMed)

Xu X, Zu C, Zhang M, Xiao P, Hong R, Feng J, Xu H, Cui J, Yu J, Shi J, Wei G, Chang AH, Huang H, Hu Y. HLA Fully-Mismatched Sibling-Derived CD7 CAR-T Therapy Bridging to Haploidentical Hematopoietic Stem Cell Transplantation for Hepatosplenic gammadelta T-cell Lymphoma. Cell Transplant. 2023 Jan-Dec;32:9636897231194265. doi: 10.1177/09636897231194265.

Reference Type: DERIVED

PMID: 37667507 (View on PubMed)

Other Identifiers

CD7-001

Identifier Type: -

Identifier Source: org_study_id