Phase 1a/b Study of GPRC5D CART Therapy in Relapsed/Refractory Multiple Myeloma and Light-chain Amyloidosis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHadassah Medical Organization
About this trial
A Phase 1a/b Open-Label Study to Evaluate Safety and Preliminary Efficacy of GPRC5D CART Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma and Light-chain Amyloidosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age at the time of signing informed consent.
Voluntarily signed informed consent form.
Serum M-protein greater or equal to 0.5 g/dL.
Positive test for urine M-protein.
Disqualifiers
Known bulky central nervous system disease.
Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN) and direct bilirubin > 4x ULN.
Inadequate renal function defined by serum creatinine clearance/estimated clearance of <20 (ml/min).
International ratio (INR) or partial thromboplastin time (PTT) > 2 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event (provided this event is not an exclusion criteria).
Trial design
Design model
Single group
Treatments tested in this trial
GPRC5D CART
Biological/VaccineThe GPRC5D CART is defines as autologous bone marrow derived T-cells transduced with anti-GPRC5D CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human GPRC5D. The GPRC5D CART is provided cryopreserved.
Treatment groups
160 Participants
are divided into 1 treatment groupGroup A: GPRC5D CARTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate safety of GPRC5D CART
Incidence of Serious Adverse Events and Adverse Events of Special Interest related to study treatment
Time frame
24 months following infusion2
Evaluate dose dependent GPRC5D CART safety.
Determine the maximum tolerated single dose (MTD) in Phase 1a.
Time frame
21 days following infusionSecondary outcomes
1
Overall response rate
Overall Response Rate is defined by proportion of subjects with Partial Response or better per IMWG Criteria for MM, and Partial Response or better per Hematologic Response Criteria for AL
Time frame
24 months following infusion2
Complete response rate
Complete Response Rate is defined by proportion of subjects with Complete Response per IMWG Criteria for MM or per Hematologic Response Criteria for AL
Time frame
24 months following infusion3
Progression-Free Survival
Progression-Free Survival is defined as the time from the date of the initial infusion the date of first documented disease progression, or death due to any cause, whichever occurs first
Time frame
24 months following infusion4
Overall Survival
Overall Survival is defined by the date of the initial infusion to the date of the patient's death due to any cause
Time frame
24 months following infusionSponsors and contacts
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Source ClinicalTrials.gov
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