Safety and Efficacy of GPRC5D CAR-T Cell Therapy in Relapsed/Refractory Plasma Cell Disorders
ConditionPlasma Cell Dyscrasias
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age14-75
SponsorQi deng
About this trial
This study is an open-label, single-arm, dose-escalation and expansion, prospective clinical trial. It enrolls patients with relapsed/refractory plasma cell disorders, administers GPRC5D CAR-T cell therapy, follows up to observe adverse reactions after medication, collects relevant data on treatment efficacy, evaluates the safety and efficacy of CAR-T cells, and simultaneously investigates the cellular kinetic characteristics of CAR-T cells.
Eligibility criteria
Qualifiers
According to the World Health Organization (WHO) Classification of Haematopoietic and Lymphoid Tissue Tumours (2022), patients with relapsed/refractory plasma cell disorders that have received adequate treatment and lack effective therapeutic options, including: multiple myeloma, plasma cell leukemia, extramedullary plasmacytoma, solitary plasmacytoma, or primary amyloidosis.i) Relapsed: Disease progression occurs after one or more prior treatments, requiring salvage therapy, and does not meet the criteria for refractory disease.ii) Refractory: No response to initial treatment regimen or salvage therapy, or disease progression within 60 days after treatment. No response is defined as failure to achieve minimal response (MR) or disease progression during treatment.
The subject's predicted survival time is not less than three months.
Tumor cells confirmed to be GPRC5D positive by Flow Cytometry (FCM) or Immunohistochemistry.
The subject failed autologous and allogeneic hematopoietic stem cell transplantation.
Disqualifiers
Severe heart failure with left ventricular ejection fraction (LVEF) < 50%.
History of severe pulmonary function impairment.
Concurrent other progressive malignant tumors.
Concurrent severe infection that cannot be effectively controlled.
Trial design
Treatments tested in this trial
- GPRC5D CAR-T cell intravenous infusion
Treatment groups
18 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Qi deng
Lead sponsor
Tianjin First Central Hospital
Sponsor institution
Source ClinicalTrials.gov