The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.

A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

Multiple Myeloma

Kahler's Disease

Blood Cancer

Hematologic Neoplasms

Hematologic Malignancies

Hematology

Hematological Malignancies

Cyclophosphamide

Cilta-cel

Fludarabine

Induction therapy

A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel

Participants in CR or better who achieve MRD-negative status at 12 months after cilta-cel infusion with a sensitivity of 10^-5, prior to progressive disease (PD) or subsequent anti-myeloma therapy will be reported.

Overall MRD-negative CR is defined as the percentage of participants who achieve MRD-negative CR with a sensitivity of 10^-5 at any time after enrollment but prior to PD or subsequent anti-myeloma therapy.

CR or better is defined as the percentage of participants who achieve a CR or stringent complete response (sCR) according to the most recent international myeloma working group (IMWG) criteria.

PFS is defined as the time from the date of enrollment to the date of first documented PD, as defined in the most recent IMWG criteria, or death due to any cause, whichever occurs first.

OS is measured from the date of enrollment to the date of the participant's death.

An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.

Participants with abnormalities in laboratory parameters (hematology, chemistry) will be reported.

Levels of Cilta-cel T cell expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.

The presence of anti-cilta-cel antibodies will be determined from anti-drug antibody samples collected from each participant.

Percentage of participants with presence of RCL will be reported.

Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide daily for 3 days, followed by cilta-cel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.

Participants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide and fludarabine daily for 3 days, followed by Ciltacel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.

The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given
with a fludarabine-free lymphodepletion regimen (a process of reducing the number of
lymphocytes, a type of white blood cell in the body, typically through chemotherapy).

Participants in CR or better who achieve MRD-negative status at 12 months after cilta-cel
infusion with a sensitivity of 10^-5, prior to PD or subsequent anti-myeloma therapy will
be reported.

Overall MRD-negative CR is defined as the percentage of participants who achieve
MRD-negative CR with a sensitivity of 10^-5 at any time after enrollment but prior to PD
or subsequent anti-myeloma therapy.

CR or better is defined as the percentage of participants who achieve a CR or stringent
complete response (sCR) according to the most recent international myeloma working group
(IMWG) criteria.

PFS is defined as the time from the date of enrollment to the date of first documented
progressive disease (PD), as defined in the most recent IMWG criteria, or death due to
any cause, whichever occurs first.

An AE is any untoward medical occurrence in a clinical study participant administered a
pharmaceutical (investigational or non-investigational) product. An AE does not
necessarily have a causal relationship with the treatment. Severity will be graded
according to the National Cancer Institute Common Terminology Criteria for Adverse Events
(NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate,
Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.

Participants with abnormalities in laboratory parameters (hematology, chemistry) will be
reported.

Levels of Cilta-cel T cell expansion (proliferation), and persistence via monitoring
CAR-T positive cell counts and CAR transgene level will be reported.

The presence of anti-cilta-cel antibodies will be determined from anti-drug antibody
samples collected from each participant.

Participants will undergo apheresis and continue to receive 1-2 more cycles of the
induction regimen (DRd or VRd regimen, in accordance with institution standard of care,
and is not considered study treatment) that they were receiving prior to screening. After
completion of induction therapy, participants will receive a conditioning regimen of
cyclophosphamide daily for 3 days, followed by cilta-cel IV infusion on Day 1.
Participants will later enter the post-treatment phase, which will start on Day 113 and
last until end of study or cohort completion.

A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

Trials at a glance

Trials at a glance