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
SponsorNanjing IASO Biotechnology Co., Ltd.
About this trial
This study is a single-center, open-label, dose-escalation 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).
The proportion of primitive immature or monoclonal plasma cells detected by bone marrow cytology, bone marrow biopsy, or flow cytometry is ≥ 10%.
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-GPRC5D
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Nanjing IASO Biotechnology Co., Ltd.
Lead sponsor
Ruijin Hospital
Collaborator
Source ClinicalTrials.gov