Health Trials

Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed/Refractory Autoimmune Diseases

ConditionsRefractory/Relapsed Systemic Lupus ErythematosusRefractory / Relapsed / Progressive Systemic SclerosisRefractory / Relapsing / Progressive Inflammatory MyopathyRefractory / Relapsed Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated VasculitisRefractory / Relapsed Connective Tissue Disease-Associated Thrombocytopenia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory autoimmune diseases

Eligibility criteria

Qualifiers

Age ≥18 years (including 18 years), no gender restrictions.

Confirmed by flow cytometry to express CD19 or BCMA antigen on the surface of peripheral blood B cells.

Bone marrow function: Neutrophil count ≥ 1 × 10^9/L (no colony-stimulating factor therapy within 2 weeks prior to testing); Haemoglobin ≥ 60 g/L.

Liver function: Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN) (excluding ALT elevation due to inflammatory myopathy) ; Aspartate Aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy); Total Bilirubin (TBIL) ≤ 2 times ULN (may be relaxed to ≤ 3.0 times ULN for subjects with Gilbert's syndrome).

Disqualifiers

-Individuals with a history of severe drug allergies or an allergic constitution.

Presence or suspected presence of uncontrolled or treatable fungal, bacterial, viral, or other infections.

Active, severe central nervous system disorders caused by autoimmune or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).

Patients with cardiac insufficiency.

Trial design

Treatments tested in this trial

  • Allogeneic CD19/BCMA-targeted CAR-γδT cell injection
  • Cyclophosphamide
  • Fludarabine

Treatment groups

9 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov