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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05172596




Registration number
NCT05172596
Ethics application status
Date submitted
22/12/2021
Date registered
29/12/2021
Date last updated
12/11/2024

Titles & IDs
Public title
PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma
Scientific title
A Phase 2 Study of PHE885, B-cell Maturation Antigen (BCMA)- Directed CAR-T Cells in Adult Participants With Relapsed and Refractory Multiple Myeloma.
Secondary ID [1] 0 0
2021-003747-22
Secondary ID [2] 0 0
CPHE885B12201
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 - Patients will receive PHE885


Treatment: Other: PHE885
Intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate (ORR) per Independent Review Committee (IRC) in Efficacy Analysis Set
Timepoint [1] 0 0
24 Months
Secondary outcome [1] 0 0
Key Secondary End point: MRD Negativity rate in Bone Marrow
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Complete response rate (CRR)
Timepoint [2] 0 0
24 Months
Secondary outcome [3] 0 0
Time to response
Timepoint [3] 0 0
24 Months
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
24 Months
Secondary outcome [5] 0 0
Progression free survival (PFS)
Timepoint [5] 0 0
24 Months
Secondary outcome [6] 0 0
Time to next anti-myeloma treatment (TTNT)
Timepoint [6] 0 0
24 Months
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
24 Months
Secondary outcome [8] 0 0
Durability of Minimal Residual Disease (MRD)negativity
Timepoint [8] 0 0
24 Months
Secondary outcome [9] 0 0
Patient Reported Outcomes (PRO): EQ-5D-5L Health Questionnaire
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
Patient Reported Outcomes (PRO): EORTC-QLQ-C30
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
Patient Reported Outcomes (PRO): EORTC-QLQ-MY20
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
PHE885 manufacturing success rate
Timepoint [12] 0 0
24 Months
Secondary outcome [13] 0 0
Manufacturing turnaround time
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
Transgene of PHE885 concentrations over time in peripheral blood and bone marrow
Timepoint [14] 0 0
24 Months
Secondary outcome [15] 0 0
Cellular kinetics parameter: Cmax
Timepoint [15] 0 0
24 Months
Secondary outcome [16] 0 0
Cellular kinetics parameter: Tmax
Timepoint [16] 0 0
24 Months
Secondary outcome [17] 0 0
Cellular kinetics parameter: AUC
Timepoint [17] 0 0
24 months
Secondary outcome [18] 0 0
Immunogenicity to PHE885
Timepoint [18] 0 0
24 Months

Eligibility
Key inclusion criteria
1. =18 years of age at the time of informed consent form (ICF) signature
2. Adult patients after failure of three or more lines of therapy including an IMiD (e.g., lenalidomide or pomalidomide), a proteasome inhibitor (e.g., bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g., daratumumab, isatuximab), and who have documented evidence of disease progression (IMWG criteria) 3, Must have received =2 consecutive cycles of treatment for at least three prior regimens unless deemed refractory to that regimen (i.e., progressive disease as the best response)

4. Must be refractory to the last treatment regimen (defined as progressive disease on or within 60 days measured from last dose of last regimen).

5. Measurable disease at enrollment as defined by the protocol 6. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening 7. Must have a leukapheresis material of non-mobilized cells accepted for manufacturing
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. 2.Participants who have received prior BCMA -directed bi-specific antibodies or anti-BCMA antibody drug conjugate.

3. Prior autologous SCT within 3 month or allogenic SCT within 6 months prior to signing informed consent.

4.Plasma cell (PC) leukemia and other plasmacytoid disorders, other than MM 5.POEMS syndrome 6.Active central nervous system (CNS) involvement by malignancy 7.Patients with active neurological autoimmune or inflammatory disorders 8.Inadequate cardiac, renal, hepatic or hematologic function as defined in the protocol.

Other protocol-defined Inclusion/Exclusion may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Phase 2
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
3/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/02/2025
Actual
Sample size
Target
Accrual to date
Final
146
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Brazil
State/province [7] 0 0
BA
Country [8] 0 0
Brazil
State/province [8] 0 0
SP
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
France
State/province [10] 0 0
Lille
Country [11] 0 0
France
State/province [11] 0 0
Nantes Cedex 1
Country [12] 0 0
France
State/province [12] 0 0
Paris 10
Country [13] 0 0
France
State/province [13] 0 0
Poitiers
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Germany
State/province [15] 0 0
Heidelberg
Country [16] 0 0
Germany
State/province [16] 0 0
Koeln
Country [17] 0 0
Germany
State/province [17] 0 0
Wuerzburg
Country [18] 0 0
Greece
State/province [18] 0 0
GR
Country [19] 0 0
Greece
State/province [19] 0 0
Athens
Country [20] 0 0
Israel
State/province [20] 0 0
Ramat Gan
Country [21] 0 0
Israel
State/province [21] 0 0
Tel Aviv
Country [22] 0 0
Italy
State/province [22] 0 0
BO
Country [23] 0 0
Italy
State/province [23] 0 0
MI
Country [24] 0 0
Japan
State/province [24] 0 0
Aichi
Country [25] 0 0
Japan
State/province [25] 0 0
Hokkaido
Country [26] 0 0
Japan
State/province [26] 0 0
Kyoto
Country [27] 0 0
Japan
State/province [27] 0 0
Miyagi
Country [28] 0 0
Saudi Arabia
State/province [28] 0 0
Riyadh
Country [29] 0 0
Singapore
State/province [29] 0 0
Singapore
Country [30] 0 0
Spain
State/province [30] 0 0
Castilla Y Leon
Country [31] 0 0
Spain
State/province [31] 0 0
Navarra
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Birmingham
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Glasgow

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase II study to determine the efficacy and safety of PHE885, a BCMA-directed CAR-T cell therapy, manufactured with a new process. The CAR-T cell therapy will be investigated as a single agent in relapsed and refractory multiple myeloma
Trial website
https://clinicaltrials.gov/study/NCT05172596
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05172596