Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHadassah Medical Organization
About this trial
A Phase 1a/1b Open-Label Study with Dose Escalation and Expansion Phases to Evaluate Safety and Preliminary Efficacy of Naïve HBI0101 CART Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma.
Eligibility criteria
Qualifiers
≥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.
Urine M-protein greater or equal to 200 mg/24 h.
Disqualifiers
Contraindication to a study treatment/procedure or is anticipated to receive treatment/procedure that may preclude performance of study procedures.
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/or direct bilirubin > 4x ULN.
Inadequate renal function defined by estimated clearance of <20(ml/min).
Trial design
Treatments tested in this trial
- Naive HBI0101 CAR-T
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov