Study of durcabtagene autoleucel, in adult patients with relapsed and refractory Multiple Myeloma

Phase 1

• Conditions: Adult participants with relapsed and refractory multiple myeloma after failure of 3 or more different prior 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 and documented evidence of progressive disease per IMWG criteria on the last prior therapy. Participants must be refractory to the last line of therapy.; MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-003747-22-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1. =18 years of age at the time of informed consent form (ICF)
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2. Adult participants with relapsed and refractory multiple myeloma who
have received at least 3 prior 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 have documented evidence of disease
progression (IMWG criteria).
3. Must be refractory to the last treatment regimen (defined as
progressive disease on or within 60 days measured from last dose of last
regimen).
4. Measurable disease at enrollment as defined by the protocol.
5. Eastern Cooperative Oncology Group (ECOG) performance status that
is either 0 or 1 at screening.
6. Must have a leukapheresis material of non-mobilized cells accepted
for manufacturing.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 81
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

1. Prior administration of a genetically modified cellular product
including prior BCMA CAR-T therapy. Participants who have received
prior BCMA-directed bi-specific antibodies or anti-BCMA antibody drug
conjugate.
2. Prior autologous stem cell transplantation (SCT) within 3 months or
allogeneic stem cell transplantation within 6 months prior to signing
informed consent.
3. Plasma cell (PC) leukemia and other plasmacytoid disorders, other
than MM.
4. POEMS syndrome (plasma cell dyscrasia with polyneuropathy,
organomegaly, endocrinopathy, monoclonal protein, and skin changes).
5. Active central nervous system (CNS) involvement by malignancy.
6. Participants with active neurological autoimmune or inflammatory
disorders.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified