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Multiple MyelomaPhase 2NCT05172596

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

A Phase 2 study testing PHE885 in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 36 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Multiple Myeloma
What is being tested?
PHE885
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
36 sitesin 14 countries
Study dates
3 Mar 2022to 21 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

  • 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.

Trial locations and contacts

36 sites in 14 countries.

36 sites in 14 countries

United States6 sites

  • Emory University School of Medicine-Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Stanford University

    Palo Alto, California, 94304

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • Fred Hutch Cancer Research

    Seattle, Washington, 98109

Other trials in United States

France4 sites

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Nantes, 44093

  • Novartis Investigative Site

    Paris, 75475

  • Novartis Investigative Site

    Poitiers, 86021

Other trials in France

Germany4 sites

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080

Other trials in Germany

Japan4 sites

  • Novartis Investigative Site

    Kyoto, Kyoto, 602-8566

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4678602

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060 8648

  • Novartis Investigative Site

    Sendai, Miyagi, 980 8574

Other trials in Japan

Australia2 sites

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050

  • Novartis Investigative Site

    Melbourne, Victoria, 3004

Other trials in Australia

Brazil2 sites

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 41253-190

  • Novartis Investigative Site

    São Paulo, São Paulo, 01509-900

Other trials in Brazil

Greece2 sites

  • Novartis Investigative Site

    Athens, 106 76

  • Novartis Investigative Site

    Thessaloniki, 570 10

Other trials in Greece

Israel2 sites

  • Novartis Investigative Site

    Ramat Gan, 5265601

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Italy2 sites

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Milan, MI, 20133

Other trials in Italy

Singapore2 sites

  • Novartis Investigative Site

    Singapore, 119074

  • Novartis Investigative Site

    Singapore, 169608

Other trials in Singapore

Spain2 sites

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Salamanca, 37007

Other trials in Spain

United Kingdom2 sites

  • Novartis Investigative Site

    Birmingham, West Midlands, B15 2TH

  • Novartis Investigative Site

    Glasgow, Scotland, G51 4TF

Other trials in United Kingdom

Canada1 site

  • Novartis Investigative Site

    Calgary, Alberta, T2N 5G2

Other trials in Canada

Saudi Arabia1 site

  • Novartis Investigative Site

    Riyadh, 11211

Other trials in Saudi Arabia

About this study

Official 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.

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

Read the detailed description

This clinical trial employs an open label, single arm, multi-center design with primary analysis testing overall response rate ( ORR), including one interim analysis for futility and one interim analysis for efficacy.

The trial population includes adult patients with relapsed and refractory multiple myeloma (MM) after failure of 3 or more lines of therapy, including failing an immunomodulatory drug (IMiD), a proteasome inhibitor (PI) and an anti-CD38 (cluster of differentiation 38) monoclonal antibody (mAb) and who have measurable disease at enrollment per IMWG criteria . In addition, patients must be refractory to the last line of therapy

The trial will enroll 90 efficacy evaluable adult patients with relapsed and refractory MM (efficacy evaluable means participants infused with a PHE885 product at target dose 10e6 that met all release specifications).

Patients will be followed for acute and intermediate safety and efficacy within this trial for a minimum of 2 years before being transferred to the long-term follow-up trial. A long-term post-study follow-up for lentiviral vector safety will be offered under a separate destination protocol for 15 years post injection per health authority guidelines.

Being tested
PHE885
Keywords
Multiple myeloma, B-cell maturation antigen, BCMA, BCMA-directed, chimeric antigen receptor, CAR-T, PHE885
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHE885Biological

    Intravenous (IV) infusion

Study groups in NCT05172596
Study groupRoleWhat they receive
PHE885ExperimentalPatients will receive PHE885
Receives: Biological: PHE885

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR) per Independent Review Committee (IRC) in Efficacy Analysis Set

    Percentage of patients with best overall response (BOR) of either stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) according to the International Myeloma Working Group (IMWG) criteria'

    Measured: 24 Months

Secondary outcomes (18)

  1. Key Secondary End point: MRD Negativity rate in Bone Marrow

    Evaluate the efficacy of PHE885 with respect to MRD negativity rate in bone marrow measured by next generation sequencing (NGS)

    Measured: 24 months

  2. Complete response rate (CRR)

    Percentage of patients with BOR of sCR or CR according to the IMWG criteria

    Measured: 24 Months

  3. Time to response

    Time form PHE885 infusion to the date of first documented response (PR or better)

    Measured: 24 Months

  4. Duration of Response (DOR)

    Time from first documented response (PR or better) until relapse or death due to any cause

    Measured: 24 Months

  5. Progression free survival (PFS)

    Time from PHE885 infusion until progression or death due to any cause

    Measured: 24 Months

  6. Time to next anti-myeloma treatment (TTNT)

    Time from PHE885 infusion until start of new anti-myeloma therapy or death due to any cause

    Measured: 24 Months

  7. Overall Survival (OS)

    Time from PHE885 infusion until death due to any cause

    Measured: 24 Months

  8. Durability of Minimal Residual Disease (MRD)negativity

    Time from the start of undetectable MRD to the time of reappearance of detectable MRD

    Measured: 24 Months

  9. Patient Reported Outcomes (PRO): EQ-5D-5L Health Questionnaire

    PROs as measured by EuroQoL Group EQ-5D-5L Health Questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.

    Measured: 24 months

  10. Patient Reported Outcomes (PRO): EORTC-QLQ-C30

    PROs as measured by European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC-QLQ-C30) Questionnaire will be used as a measure of health-related quality of life.

    Measured: 24 months

  11. Patient Reported Outcomes (PRO): EORTC-QLQ-MY20

    PROs as measured by EORTC-QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality.

    Measured: 24 months

  12. PHE885 manufacturing success rate

    Percentage of enrolled patients for whom PHE885 product was manufactured that met all release specifications

    Measured: 24 Months

  13. Manufacturing turnaround time

    Time from pick of cryopreserved material at the clinic or hospital until return to the clinical or hospital

    Measured: 24 months

  14. Transgene of PHE885 concentrations over time in peripheral blood and bone marrow

    As determined by quantitative polymerase chain reaction (qPCR)

    Measured: 24 Months

  15. Cellular kinetics parameter: Cmax

    The maximum transgene level at Tmax

    Measured: 24 Months

  16. Cellular kinetics parameter: Tmax

    The time to peak transgene level

    Measured: 24 Months

  17. Cellular kinetics parameter: AUC

    The Area under the curve of the transgene level

    Measured: 24 months

  18. Immunogenicity to PHE885

    Summary of pre-existing and treatment-induced immunogenicity (cellular and humoral) of PHE885

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start3 Mar 2022
  3. Primary completion21 May 2025
  4. Study completion21 May 2025

Why it stopped: The study was terminated since the sponsor made the decision to discontinue further development of the study drug durcabtagene autoleucel (PHE885).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05172596
Sponsor's protocol ID
CPHE885B12201
Other IDs
2021-003747-22
Status last verified
Jan 2026
First submitted
22 Dec 2021
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The Trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PHE885 in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 36 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, France, Germany, Japan, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated since the sponsor made the decision to discontinue further development of the study drug durcabtagene autoleucel (PHE885).). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) per Independent Review Committee (IRC) in Efficacy Analysis Set (time frame: 24 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05172596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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