CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia

NCT ID: NCT06633328

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2027-10-20

Brief Summary

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with severe aplastic anemia

Detailed Description

This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of CD7 CAR-T Bridging to allo-HSCT in the treatment of severe aplastic anemia.The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).

Conditions

Aplastic Anemia

Study Design

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

Study Groups

Treatment Group

Aplastic Anemia

Group Type: EXPERIMENTAL

CD7 CAR-T cells injection

Intervention Type: DRUG

CD7 CAR T cells treat patients with severe aplastic anemia

Allogeneic hematopoietic stem cell transplantation

Intervention Type: OTHER

In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with severe aplastic anemia

Interventions

CD7 CAR-T cells injection

CD7 CAR T cells treat patients with severe aplastic anemia

Intervention Type: DRUG

Allogeneic hematopoietic stem cell transplantation

In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with severe aplastic anemia

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Chinese expert consensus on the diagnosis and treatment of aplastic anemia（2017）, Diagnosis of severe aplastic anemia ，1. The degree of bone marrow cell proliferation < 25%, or 25%-50% but residual hematopoietic cells < 30%；2. With pancytopenia (at least two of the following peripheral blood parameters) : (1) absolute neutrophil <0.5×10^9/L; (2) Platelet count< 20×10^9/L; (3) The absolute value of reticulocytes <20×109/L;
• Suitable donors (relatives) with allogeneic HSCT indications and at least haploid allogeneic transplantation;
• Patients who are not suitable or unwilling to undergo traditional allogeneic hematopoietic stem cell transplantation;
• creatinine clearance > 60ml/min; without liver invasion, serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were both ≤ 3 times the upper limit of the normal range. If there is liver invasion, serum erythrambirubin ≤ 3 times the upper limit of normal, and serum ALT and AST are both ≤ 5 times the upper limit of the normal range;
• Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
• No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
• Estimated survival time ≥ 3 months;
• ECOG performance status 0 to 1;
• Females and males of childbearing potential must agree to use adequate contraception prior to study entry, during study participation, and for 6 months after infusion (the safety of this therapy for unborn children is not known and has unknown risks);
• Those who voluntarily participated in this trial and provided informed consent;

Exclusion Criteria

• Allergy to pre-treatment measures；
• Those with acute graft versus host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening; Those who have received systemic drug therapy for GvHD within 4 weeks before the reinfusion；
• History of epilepsy or other central nervous system disorders；
• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• Less than 100 days after allogeneic hematopoietic stem cell transplantation；
• Patients with HIV infection，Active infection of hepatitis B virus or hepatitis C virus，Uncured active infection；
• The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• Received anti-cancer chemotherapy or other drug treatment within 2 weeks prior to screening;
• Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the study.

• 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

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

He Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

The First Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Z Huang, MD

Role: CONTACT

hehuangyu@126.com

13605714822

Yongxian Hu, MD

Role: CONTACT

huyongxian2000@aliyun.com

86-15957162012

Facility Contacts

He Huang, MD

Role: primary

hehuangyu@126.com

0571-87233772

Yongxian Hu, MD

Role: backup

huyongxian2000@aliyun.com

0571-87233772

Other Identifiers

TXB2024009

Identifier Type: -

Identifier Source: org_study_id