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Multiple MyelomaPhase 1NCT04318327

BCMA-directed CAR-T Cell Therapy in Adult Patients With Multiple Myeloma

A Phase 1 study testing PHE885 in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 9 sites in 4 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 was 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. 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
96 participants
Where
9 sitesin 4 countries
Study dates
23 Jul 2020to 29 Apr 2025
Phase
Phase 1
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

  • 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

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

United States4 sites

  • Beth Israel Deaconess Medical Cente

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Uni of Chi Medi Ctr Hema and Onco

    Chicago, Illinois, 60637

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

Israel2 sites

  • Novartis Investigative Site

    Ramat Gan, 5265601

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Singapore2 sites

  • Novartis Investigative Site

    Singapore, 119074

  • Novartis Investigative Site

    Singapore, 169608

Other trials in Singapore

Australia1 site

  • Novartis Investigative Site

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: Phase I, Open Label, Study of B-cell Maturation Antigen (BCMA)-Directed CAR-T Cells in Adult Patients With Multiple Myeloma

This was 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 were investigated as a single agent in multiple myeloma

Read the detailed description

This was a phase I, open label study to characterize the safety and tolerability of a novel B-cell Maturation Antigen (BCMA)-specific chimeric antigen receptor (CAR) manufactured with a new process. In the dose escalation part (Part A) of the study, the anti-BCMA CAR-T cell therapy was studied in adult multiple myeloma (MM) subjects who were relapsed and/or refractory. In the dose evaluation part (Part B) of the study, the anti-BCMA CAR-T cell therapy was studied in newly diagnosed adult subject with MM.

Being tested
PHE885
Keywords
Multiple myeloma, B-cell maturation antigen, BCMA, anti-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

    Infusion

Study groups in NCT04318327
Study groupRoleWhat they receive
PHE885 (Part A)ExperimentalRelapsed and/or refractory multiple myeloma (r/r MM) patients will receive PHE885.
Receives: Biological: PHE885
PHE885 (Part B)ExperimentalNewly diagnosed multiple myeloma (NDMM) patients will receive PHE885.
Receives: Biological: PHE885

What is being measured

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

  1. Incidence of Dose limiting toxicities (DLT)

    Incidence of Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration

    Measured: 28 days

  2. Nature of Dose limiting toxicities (DLT)

    Nature of Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration

    Measured: 28 days

  3. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Measured: 24 months

Secondary outcomes (16)

  1. Manufacture success rate (defined as number of subjects treated with planned target dose divided by total number of subjects treated)

    evaluate the feasibility of the manufacturing process

    Measured: 24 Months

  2. Overall Response Rate (ORR) in Part A

    Proportion of subjects with the best overall response (BOR) of PR (partial response) or better, as determined by local investigator using the IMWG Criteria

    Measured: 24 months

  3. ORR in Part B

    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

    Measured: 24 months

  4. Response rate at 3 and 6 months in Part A

    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

    Measured: 3 months, 6 months

  5. Overall response rate at 3 and 6 months in Part B

    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

    Measured: 3 months, 6 months

  6. Overall Complete Response Rate (CRR) in Part A

    Proportion of subjects with the BOR of CR or better, as determined by local investigator using the IMWG Criteria

    Measured: 24 months

  7. Overall CRR in Part B

    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

    Measured: 24 months

  8. CRR at months 3 and 6 in Part A

    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

    Measured: 3 months, 6 months

  9. CRR at months 3 and 6 in Part B

    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

    Measured: 3 months, 6 months

  10. DOR (duration of response) in Part A

    DOR as assessed by local investigator: the time from achievement of PR or better to relapse or death due to MM (multiple myeloma)

    Measured: from disease response to disease progression, assessed up to approximately 24 months

  11. DOR in Part B

    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

    Measured: from disease response to disease progression, assessed up to approximately 24 months

  12. Cmax of BCMA CAR-T cells

    through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow

    Measured: 24 months

  13. Tmax of BCMA CAR-T cells

    through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow

    Measured: 24 months

  14. AUC of BCMA CAR-T cells

    through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow

    Measured: 24 months

  15. Clast of BCMA CAR-T cells

    through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow

    Measured: 24 months

  16. number of patients with pre-existing and treatment induced immunogenicity (cellular and humoral) of BCMA CAR-T cell therapy

    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 posted23 Mar 2020
  2. Study start23 Jul 2020
  3. Primary completion29 Apr 2025
  4. Study completion29 Apr 2025

Why it stopped: Business decision

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04318327
Sponsor's protocol ID
CADPT07A12101
Status last verified
Jul 2026
First submitted
20 Mar 2020
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PHE885 in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 9 sites in 4 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 7 inclusion and 5 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Israel, Singapore, Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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: Business decision). 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?

Incidence of Dose limiting toxicities (DLT) (time frame: 28 days). The study lists 3 primary outcomes in all. 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 NCT04318327.

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 9 Jul 2026.

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