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NCT Number: NCT07149857

A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented diagnosis of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy): Serum monoclonal paraprotein (M-protein) level greater than equal to (>=)1.0 grams per deciliter (g/dL) or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma in whom the only measurable disease is by serum free light chain (FLC) levels in the serum: involved serum free light chain >= 10 mg/dL and abnormal serum free light chain ratio
  • Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advanced age; or (b) Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or (c) Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment
  • Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled (screening can commence as early as during Cycle 3 of induction). Participants must have achieved >= partial response (PR) on the most recent disease assessment to be enrolled
  • Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1
  • Must be willing and able to adhere to the lifestyle restrictions specified in the protocol

Exclusion criteria

  • Frailty index of >= 2 according to Myeloma Geriatric Assessment score
  • Known allergies, hypersensitivity, or intolerance to study intervention or its active agents
  • Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib
  • Participants who require continuous supplemental oxygen

Treatment and study plan

Cilta-cel

Drug

Cilta-cel will be administered as intravenous infusion.

Other names: JNJ-68284528

Cyclophosphamide

Drug

Cyclophosphamide will be administered as intravenous infusion.

Induction therapy

Drug

Induction therapy consist of bortezomib, lenalidomide, and dexamethasone (VRd) or daratumumab, lenalidomide, and dexamethasone (DRd) or daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd), will will be administered.

Fludarabine

Drug

Fludarabine will be administered as intravenous infusion.

Primary outcomes

  1. Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion

    Time frame: At least 12 months after Cilta-cel infusion on Day 1

    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.

Secondary outcomes

  1. Overall MRD-negative CR Rate

    Time frame: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

    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.

  2. CR or better status

    Time frame: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

    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.

  3. Progression Free Survival (PFS)

    Time frame: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

    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.

  4. Overall Survival (OS)

    Time frame: Up to 3 years and 4 months

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

  5. Number of Participants with Adverse Event (AE) by Severity

    Time frame: Up to 3 years and 4 months

    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.

  6. Number of Participants with Abnormalities in Laboratory Parameters

    Time frame: Up to 3 years and 4 months

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

  7. Levels of Cilta-cel T-Cell Expansion, and Persistence

    Time frame: Up to 3 years and 4 months

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

  8. Number of Participants with Anti-Cilta-Cel Antibodies

    Time frame: Up to 3 years and 4 months

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

  9. Percentage of Participants with Presence of Replication-competent Lentivirus (RCL)

    Time frame: Up to 3 years and 4 months

    Percentage of participants with presence of RCL will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: CARTITUDE-10

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 2, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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