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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
Scientific title
Phase I, Open Label, Study of B-cell Maturation Antigen (BCMA)-Directed CAR-T Cells in Adult Patients With Multiple Myeloma
Secondary ID [1] 0 0
CADPT07A12101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Dose limiting toxicities (DLT)
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Nature of Dose limiting toxicities (DLT)
Timepoint [2] 0 0
28 days
Primary outcome [3] 0 0
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timepoint [3] 0 0
24 months
Secondary outcome [1] 0 0
Manufacture success rate (defined as number of subjects treated with planned target dose divided by total number of subjects treated)
Timepoint [1] 0 0
24 Months
Secondary outcome [2] 0 0
Overall Response Rate (ORR) in Part A
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
ORR in Part B
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Response rate at 3 and 6 months in Part A
Timepoint [4] 0 0
3 months, 6 months
Secondary outcome [5] 0 0
Overall response rate at 3 and 6 months in Part B
Timepoint [5] 0 0
3 months, 6 months
Secondary outcome [6] 0 0
Overall Complete Response Rate (CRR) in Part A
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Overall CRR in Part B
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
CRR at months 3 and 6 in Part A
Timepoint [8] 0 0
3 months, 6 months
Secondary outcome [9] 0 0
CRR at months 3 and 6 in Part B
Timepoint [9] 0 0
3 months, 6 months
Secondary outcome [10] 0 0
DOR (duration of response) in Part A
Timepoint [10] 0 0
from disease response to disease progression, assessed up to approximately 24 months
Secondary outcome [11] 0 0
DOR in Part B
Timepoint [11] 0 0
from disease response to disease progression, assessed up to approximately 24 months
Secondary outcome [12] 0 0
Cmax of BCMA CAR-T cells
Timepoint [12] 0 0
24 months
Secondary outcome [13] 0 0
Tmax of BCMA CAR-T cells
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
AUC of BCMA CAR-T cells
Timepoint [14] 0 0
24 months
Secondary outcome [15] 0 0
Clast of BCMA CAR-T cells
Timepoint [15] 0 0
24 months
Secondary outcome [16] 0 0
number of patients with pre-existing and treatment induced immunogenicity (cellular and humoral) of BCMA CAR-T cell therapy
Timepoint [16] 0 0
24 Months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/02/2026
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Wisconsin
Country [4] 0 0
Israel
State/province [4] 0 0
Ramat Gan
Country [5] 0 0
Israel
State/province [5] 0 0
Tel Aviv
Country [6] 0 0
Singapore
State/province [6] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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