CD7 CAR-T Cell Sequential Allo-HSCT for Non-malignant Blood and Immune System Diseases

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

About this trial

A Clinical Study on the Safety and Effectiveness of CD7 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation for Non-malignant Blood and Immune System Diseases

Eligibility criteria

Qualifiers

1. Non-malignant blood and immune system diseases include: hereditary bone marrow failure, congenital immune deficiency, hemoglobinopathy and other non-malignant blood and immune system diseases,

Confirmed hereditary bone marrow failure syndrome. Including: Fanconi anemia, congenital pure red cell aplastic anemia, congenital dyskeratosis, Scheux-Day syndrome, congenital neutropenia, various bone marrow failure related congenital thrombocytopenia and other unclassified congenital bone marrow exhaustion diseases;

It meets the criteria of clinical manifestation, immune function and gene diagnosis of immune deficiency disease;

Diagnosed with hemoglobinopathy and dependent on blood transfusions; serum ferritin levels are < 3000 μg/L, with cardiac and hepatic iron content indicating moderate or lower iron overload; documentation of iron chelation therapy (including prescriptions or invoices) for at least three months prior to screening is available; no hydroxyurea, ruxolitinib, decitabine, or cytarabine has been administered in the three months preceding enrollment. The spleen size must not extend beyond the umbilical horizontal line or the midline of the abdomen. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is indicated, and suitable donors for related allo-HSCT are available.

Disqualifiers

1. People with a history of epilepsy or other central nervous system disorders;

2. Epstein-Barr virus (EBV) DNA positive;

3. People with a history of prolonged QT interval or serious heart disease;

4. People with active hepatitis B or C virus;

Trial design

Treatments tested in this trial

  • CD7 CAR-T cells injection
  • Allo-HSCT

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Zhejiang University

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

Yake Biotechnology Ltd.

Collaborator