Health Trials

CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia

ConditionAplastic Anemia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorZhejiang University

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • CD7 CAR-T cells injection
  • Allogeneic hematopoietic stem cell transplantation

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

The First Affiliated Hospital of Zhejiang University School of MedicineRecruiting310003, Hanzhou, ZhejiangChinaChina

Sponsors and collaborators

Zhejiang University

Lead sponsor

Yake Biotechnology Ltd.

Collaborator

Source ClinicalTrials.gov