PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma

A Phase 2 Study of PHE885, B-cell Maturation Antigen (BCMA)- Directed CAR-T Cells in Adult Participants With Relapsed and Refractory Multiple Myeloma.

ClinicalTrials.gov Identifier: NCT05172596

Novartis Reference Number: CPHE885B12201

Last Update: Mar 10, 2023

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Multiple Myeloma
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Feb 13, 2022
Completion date 
Dec 16, 2025
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
PHE885
Intravenous (IV) infusion

Eligibility Criteria

Inclusion Criteria:

≥18 years of age at the time of informed consent form (ICF) signature
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

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 Locations

United States
Dana Farber Cancer Institute Main Site
Recruiting
Boston, 02215 - Massachusetts
Contact: Adam Sperling
United States
Oregon Health and Science Univ
Recruiting
Portland, 97239 - Oregon
Contact: Denise Lackey (503-346-7894) - [email protected] - Levanto Schachter
United States
Australia
Novartis Investigative Site
Recruiting
VIC, 3004
Melbourne
Australia
Novartis Investigative Site
Recruiting
Camperdown, 2050
New South Wales
Australia
France
Novartis Investigative Site
Recruiting
Lille, 59037
-
France
Novartis Investigative Site
Recruiting
Nantes Cedex 1, 44093
-
France
Novartis Investigative Site
Recruiting
Paris Cedex 10, 75475
-
France
Novartis Investigative Site
Recruiting
Poitiers, 86021
-
France
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20246
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Greece
Novartis Investigative Site
Recruiting
Thessaloniki, 570 10
GR
Greece
Israel
Novartis Investigative Site
Recruiting
Ramat Gan, 52621
-
Israel
Novartis Investigative Site
Recruiting
Tel Aviv, 6423906
-
Israel
Italy
Novartis Investigative Site
Recruiting
Bologna, 40138
BO
Italy
Novartis Investigative Site
Recruiting
Milano, 20133
MI
Italy
Japan
Novartis Investigative Site
Recruiting
Nagoya-city, 467-8602
Aichi
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Kyoto-city, 602-8566
Kyoto
Japan
Novartis Investigative Site
Recruiting
Sendai city, 980 8574
Miyagi
Japan
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119228
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169608
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Salamanca, 37007
Castilla Y Leon
Spain
Novartis Investigative Site
Recruiting
Pamplona, 31008
Navarra
Spain
United Kingdom
Novartis Investigative Site
Recruiting
Birmingham, B15 2TH
-
United Kingdom
Novartis Investigative Site
Recruiting
Glasgow, G51 4TF
-
United Kingdom
Novartis Investigative Site
Recruiting
Manchester, M20 4BX
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]