A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChunrui Li
About this trial
This study is a single-center, open-label, dose-exploration study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or plasma cell leukemia.
Eligibility criteria
Qualifiers
age 18 to 75 years old, male or female.
Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs).
Evidence of cell membrane GPRC5D expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue (e.g., bone marrow biopsies, or plasmacytoma).
ECOG performance score 0-2.
Disqualifiers
Subjects who are known to have GVHD or need long-term immunosuppressive therapy.
Subjects who were receiving a used therapeutic dose of corticosteroid treatment (defined as prednisone or equivalent > 20mg) within 7 days prior to screening, except for physiological alternatives, inhalation, or topical use.
Subjects with hypertension that cannot be controlled by medication.
Subjects with serious heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmias.
Trial design
Treatments tested in this trial
- CAR-T (CAR-GPRC5D)
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Chunrui Li
Lead sponsor
Tongji Hospital
Sponsor institution
Nanjing IASO Biotechnology Co., Ltd.
Collaborator
Source ClinicalTrials.gov