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 groupSponsors and collaborators
Source ClinicalTrials.gov