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
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.
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
Design model
Single group
Treatments tested in this trial
Naive HBI0101 CAR-T
Biological/VaccineNaïve HBI0101 CART is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA. The Naïve HBI0101 CART is provided cryopreserved.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: CAR-T Naïve BCMAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Determine the Maximum Tolerated Dose (MTD)
MTD will be determined by dose limiting toxicities
Time frame
21 days after infusion2
Evaluate safety of Naïve HBI0101 CART in Parts 1a and 1b
Incidence of Serious Adverse Events and Adverse Events of Special Interest related to study treatment.
Time frame
24 Months after infusionSecondary outcomes
1
Evaluate clinical response to Naïve HBI0101 CART
Overall response rate- Percentage of participants who achieved at least partial response
Time frame
24 Months after infusion2
Evaluate Overall Survival in participants treated with Naïve HBI0101 CART
Time frame
24 Months after infusion3
Evaluate Progression-Free Survival in participants treated with Naïve HBI0101 CART
Time frame
24 Months after infusion4
Evaluate Duration of Response in participants treated with Naïve HBI0101 CART
Time frame
24 Months after infusionSponsors and contacts
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Source ClinicalTrials.gov