Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed/Refractory Acute B Lymphoblastic Leukemia

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age14+
SponsorFujian Medical University

About this trial

This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell infusion in subjects with CD19-positive R/R B-ALL.

Eligibility criteria

Qualifiers

Age > 14 years, gender unrestricted;

Failure to achieve CR after 2 cycles of standard chemotherapy;

Initial induction achieved CR, but CR duration ≤12 months;

Relapsed/refractory B-ALL refractory to first or multiple salvage therapies;

Disqualifiers

No significant hereditary diseases;

Able to comprehend the trial requirements and procedures, and willing to participate in the clinical study as required;

Signed informed consent form for the trial

Presence of central nervous system (CNS) involvement or a clinically significant history of CNS diseases, such as epilepsy and cerebrovascular diseases;

Trial design

Treatments tested in this trial

  • Cyclophosphamide
  • Fludarabine
  • QH103 Cell Injection

Treatment groups

6 Participants
are divided into 1 treatment group

Sponsors and collaborators