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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04318327
Registration number
NCT04318327
Ethics application status
Date submitted
20/03/2020
Date registered
23/03/2020
Titles & IDs
Public title
BCMA-directed CAR-T Cell Therapy in Adult Patients With Multiple Myeloma
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Scientific title
Phase I, Open Label, Study of B-cell Maturation Antigen (BCMA)-Directed CAR-T Cells in Adult Patients With Multiple Myeloma
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Secondary ID [1]
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CADPT07A12101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - PHE885
Experimental: PHE885 (Part A) - Relapsed and/or refractory multiple myeloma (r/r MM) patients will receive PHE885.
Experimental: PHE885 (Part B) - Newly diagnosed multiple myeloma (NDMM) patients will receive PHE885.
Treatment: Other: PHE885
Infusion
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Dose limiting toxicities (DLT)
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Assessment method [1]
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Incidence of Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration
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Timepoint [1]
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28 days
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Primary outcome [2]
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Nature of Dose limiting toxicities (DLT)
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Assessment method [2]
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Nature of Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration
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Timepoint [2]
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28 days
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Primary outcome [3]
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Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
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Assessment method [3]
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Timepoint [3]
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24 months
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Secondary outcome [1]
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Manufacture success rate (defined as number of subjects treated with planned target dose divided by total number of subjects treated)
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Assessment method [1]
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evaluate the feasibility of the manufacturing process
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Timepoint [1]
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24 Months
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Secondary outcome [2]
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Overall Response Rate (ORR) in Part A
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Assessment method [2]
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Proportion of subjects with the best overall response (BOR) of PR (partial response) or better, as determined by local investigator using the IMWG Criteria
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Timepoint [2]
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24 months
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Secondary outcome [3]
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ORR in Part B
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Assessment method [3]
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Proportion of subjects with VGPR (very good partial response) or PR to induction therapy who achieve the BOR of PR or better, as determined by local investigator using the IMWG Criteria
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Timepoint [3]
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24 months
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Secondary outcome [4]
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Response rate at 3 and 6 months in Part A
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Assessment method [4]
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Proportion of subjects with the overall response of PR or better at months 3 and 6 after infusion respectively, as determined by local investigator using the IMWG Criteria
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Timepoint [4]
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3 months, 6 months
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Secondary outcome [5]
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Overall response rate at 3 and 6 months in Part B
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Assessment method [5]
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Proportion of subjects with VGPR or PR to induction therapy who achieve the overall response of PR or better at months 3 and 6 after infusion respectively, as determined by local investigator using the IMWG Criteria
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Timepoint [5]
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3 months, 6 months
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Secondary outcome [6]
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Overall Complete Response Rate (CRR) in Part A
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Assessment method [6]
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Proportion of subjects with the BOR of CR or better, as determined by local investigator using the IMWG Criteria
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Timepoint [6]
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24 months
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Secondary outcome [7]
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Overall CRR in Part B
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Assessment method [7]
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Proportion of subjects with a response of VGPR or PR to induction therapy with the BOR of CR or better, as determined by local investigator using the IMWG Criteria
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Timepoint [7]
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24 months
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Secondary outcome [8]
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CRR at months 3 and 6 in Part A
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Assessment method [8]
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Proportion of subjects with the overall response of CR or better at months 3 and 6 respectively, as determined by local investigator using the IMWG Criteria
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Timepoint [8]
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3 months, 6 months
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Secondary outcome [9]
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CRR at months 3 and 6 in Part B
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Assessment method [9]
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Proportion of subjects with a response of VGPR or PR to induction therapy with the overall response of CR or better at months 3 and 6 after infusion, respectively, as determined by local investigator using the IMWG Criteria
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Timepoint [9]
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3 months, 6 months
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Secondary outcome [10]
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DOR (duration of response) in Part A
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Assessment method [10]
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DOR as assessed by local investigator: the time from achievement of PR or better to relapse or death due to MM (multiple myeloma)
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Timepoint [10]
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from disease response to disease progression, assessed up to approximately 24 months
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Secondary outcome [11]
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DOR in Part B
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Assessment method [11]
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DOR as assessed by local investigator:
* The time from the first documented disease response after infusion of CR or better to the date of the first documented progression as assessed by IMGW or death due to MM, for subjects with a response of VGPR or PR to induction therapy, and
* The time from the first documented disease response after infusion of PR or better to the date of the first documented progression as assessed by IMGW or death due to MM, for subjects with a response of VGPR or PR to induction therapy
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Timepoint [11]
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from disease response to disease progression, assessed up to approximately 24 months
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Secondary outcome [12]
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Cmax of BCMA CAR-T cells
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Assessment method [12]
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through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow
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Timepoint [12]
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24 months
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Secondary outcome [13]
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Tmax of BCMA CAR-T cells
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Assessment method [13]
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through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow
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Timepoint [13]
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24 months
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Secondary outcome [14]
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AUC of BCMA CAR-T cells
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Assessment method [14]
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through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow
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Timepoint [14]
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24 months
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Secondary outcome [15]
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Clast of BCMA CAR-T cells
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Assessment method [15]
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through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow
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Timepoint [15]
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24 months
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Secondary outcome [16]
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number of patients with pre-existing and treatment induced immunogenicity (cellular and humoral) of BCMA CAR-T cell therapy
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Assessment method [16]
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Timepoint [16]
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24 Months
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Eligibility
Key inclusion criteria
* Part A: Subjects with MM who are relapsed and/or refractory to at least 2 prior treatment regimens, including an IMiD (e.g. lenalidomide or pomalidomide), a proteasome inhibitor (e.g. bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g. daratumumab), if available, and have documented evidence of disease progression (IMWG criteria)
* Part A: ECOG performance status that is either 0 or 1 at screening
* Part B: Subjects with newly diagnosed multiple myeloma (NDMM) who have received a minimum of 4 and up to 6 cycles of standard induction therapy with VRd, D-VRd, or D-Rd, and have achieved a response of PR or better. One cycle of CyBorDex is allowed prior to induction.
* Part B: ECOG performance status that is either 0,1 or 2 at screening
* Measurable disease as defined by the protocol
* Adequate hematological values
* Must have a leukapheresis material of non-mobilized cells accepted for manufacturing
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. Patients who have received prior BCMA-directed bi-specific antibodies or antibody-drug conjugates (ADC) are not excluded.
* Autologous HSCT within 6 weeks prior to enrollment or any prior history of allogeneic hematopoietic stem cell transplant (HSCT)
* Chemotherapy or any concomitant anti-cancer therapies (other than protocol prescribed lymphodepletion (LD) chemotherapy) within 2 weeks prior to apheresis
* Treatment with small molecule targeted antineoplastics within 2 weeks of apheresis collection or 5 half-lives whichever is shorter
* Have received antibodies or immunotherapies (other than daratumumab) within 4 weeks prior to apheresis collection. Daratumumab within 3 weeks prior to apheresis collection.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
19/02/2026
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Actual
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Sample size
Target
96
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Prahran
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Recruitment postcode(s) [1]
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3181 - Prahran
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
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United States of America
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State/province [3]
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Wisconsin
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Country [4]
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Israel
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State/province [4]
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Ramat Gan
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Country [5]
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Israel
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State/province [5]
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Tel Aviv
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Country [6]
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Singapore
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State/province [6]
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Singapore
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a novel B-cell Maturation Antigen (BCMA)-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated as a single agent in multiple myeloma
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Trial website
https://clinicaltrials.gov/study/NCT04318327
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04318327