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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CAR-GPRC5D
DrugCAR-GPRC5D (RD118) is an individualized, gene-modified autologous T-cell immunotherapy product targeting GPRC5D that identifies and eliminates malignant and normal cells expressing GPRC5D. The CAR structure comprises a fully human single-domain antibody fragment (VHH) targeting GPRC5D, fused with intracellular co-stimulatory (4-1BB) and activation (CD3ζ) signaling domains.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: CAR-GPRC5D cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of dose-limiting toxicity (DLT) by dose group
Dose limiting toxicity will be assessed after infusion in each dose group
Time frame
28 days after CAR-T cell infusion2
Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group
Calculate type and incidence of adverse events (AE), serious adverse event (SAE), including those happened after lymphodepletion and after infusion, those related to study drug and lymphodepletion, or those that led to withdrawal from the study. They will also be aggregated by systematic organ classification (SOC), preferred term (PT), and severity
Time frame
2 years after CAR-T cell infusionSecondary outcomes
1
Objective response rate (ORR)
The percentage of participants who achieved PR or better response.
Time frame
2 years after CAR-T cell infusion2
Overall survival (OS)
OS is measured from the date of the initial infusion of CAR-GPRC5D to the date of the participant's death
Time frame
2 years after CAR-T cell infusion3
Duration of response (DOR) after administration
DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria
Time frame
2 years after CAR-T cell infusion4
Progression-free survival (PFS)
PFS is measured from the date of the initial infusion of CAR-GPRC5D of participants to the first time of disease progression or death for any reason
Time frame
2 years after CAR-T cell infusionOther outcomes
1
Positive rate of human anti-CAR antibody
The levels of human anti-CAR antibody of participants will be detected
Time frame
2 years after CAR-T cell infusion2
Number of Participants with replication competent lentivirus (RCL)
Number of participants exhibiting anti-drug antibodies for CAR-GPRC5D will be reported
Time frame
2 years after CAR-T cell infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nanjing IASO Biotechnology Co., Ltd.
Lead sponsor
Ruijin Hospital
Collaborator
Source ClinicalTrials.gov