A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAffiliated Hospital of Nantong University
About this trial
This study is a single-center, open-label clinical trial of single-dose of CAR T-cells in subjects with relapsed/refractory hematologic malignancy.
Eligibility criteria
Qualifiers
Voluntarily participate in the clinical study. The individual or the legal guardian fully understands the study, sign the informed consent form (ICF), and is willing and able to follow and complete all trial procedures.
Age ≥ 18 years and < 70 years.
Disease progression (PD) as assessed after first-line treatment.
Best response of SD after at least 4 cycles of first-line treatment (e.g., 4 cycles of RCHOP), with SD duration not exceeding 6 months after the last dose.
Disqualifiers
CNS-3 disease is defined as detectable tumor cells in the cerebrospinal fluid (CSF) sample with ≥ 5 WBCs/mm^3, with or without neurological changes.
CNS-2 disease is defined as detectable tumor cells in the CSF sample with < 5 WBCs/mm^3 and with neurological changes.
Brain MRI evidence shows central nervous system lymphoma. Active primary central nervous system DLBL, unless CNS involvement has been effectively treated (i.e., participants are asymptomatic) and there has been a local treatment interval of >4 weeks prior to enrollment.
Presence of active central nervous system diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases with CNS involvement.
Trial design
Treatments tested in this trial
- anti-CD19-CAR T-cells, or anti-CD30-CAR T-cells, or anti-CD20/CD30-CAR T-cells
- Fludarabine
- Cyclophosphamide
Treatment groups
9 Participants
are divided into 1 treatment groupSponsors and collaborators
Affiliated Hospital of Nantong University
Lead sponsor
Shanghai First Song Biotechnology Co., LTD
Collaborator
Source ClinicalTrials.gov