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ACTIVE NOT RECRUITINGPhase3

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

Sponsor: Kite, A Gilead Company

NCT ID: NCT06413498

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Anitocabtagene Autoleucel (drug), Cyclophosphamide (drug), Fludarabine (drug), Pomalidomide (drug)
How long the study runs
Study runs about 83 months (dates as stated)
About the drug or intervention
Anitocabtagene Autoleucel — drug: A single infusion of CAR+ transduced autologous T cells · Cyclophosphamide — drug: Administered intravenously · Fludarabine — drug: Administered intravenously · Pomalidomide — drug: Tablet administered orally · Bortezomib — drug: Administered intravenously or subcutaneously · Dexamethasone — drug: Tablet administered orally · Daratumumab — drug: Administered intravenously or subcutaneously · Carfilzomib — drug: Administered intravenously
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
452
Started
2024-08-23
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple myeloma
  • • Phase3 - 452 participants
  • • The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with multiple myeloma

Where?

  • • Bristol - University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre
  • • Cardiff - University Hospital of Wales
  • • Leeds - Leeds Teaching Hospitals NHS Trust, St James's University Hospital
  • • London - King's College Hospital
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.

More detail

After completing the treatment period, all participants who will receive anitocabtagene autoleucel, will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years.

Multiple Myeloma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD38have a negative

Treatment history

Treatments you must have had:

  • ✓ of therapy is required

What the study is looking for

  • ✓Documented historical diagnosis of multiple myeloma (MM)
  • ✓Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within...
  • ✓cancer that can be measured on scans at screening per IMWG, defined as any of the following:
  • ✓Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
  • ✓Light chain MM without cancer that can be measured on scans in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal...

Who cannot take part

  • ✗Prior B-cell maturation antigen (BCMA)-treatment that targets specific changes in the cancer
  • ✗Prior T-cell engager therapy
  • ✗Prior CAR therapy or other genetically modified T-cell therapy
  • ✗Active or prior history of central nervous system (CNS) or meningeal involvement of MM
  • ✗heart atrial or heart ventricular MM involvement
See the full criteria
Key Inclusion Criteria: * Documented historical diagnosis of multiple myeloma (MM) * Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy. * Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen * Measurable disease at screening per IMWG, defined as any of the following: * Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or * Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio * Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) Key Exclusion Criteria: * Prior B-cell maturation antigen (BCMA)-targeted therapy * Prior T-cell engager therapy * Prior CAR therapy or other genetically modified T-cell therapy * Active or prior history of central nervous system (CNS) or meningeal involvement of MM * Cardiac atrial or cardiac ventricular MM involvement * History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis * Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted. * Prior auto-SCT within 12 weeks before randomization * Prior allogeneic stem cell transplant (allo-SCT) * High-dose (eg, cumulative \> 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization * Live vaccine ≤ 4 weeks before randomization * Contraindication to fludarabine or cyclophosphamide * History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded. * Life expectancy \< 12 weeks Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where Is This Study? (6 UK sites)

University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre

Bristol BS2 8ED, United Kingdom

University Hospital of Wales

Cardiff CF14 4XW, United Kingdom

Hospital R&D contact (matched)

Elen de Lacy

PHW.Research@wales.nhs.uk02920 104468

Leeds Teaching Hospitals NHS Trust, St James's University Hospital

Leeds LS9 7TF, United Kingdom

Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

King's College Hospital

London SE5 9NU, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

University College London Hospital

London WC1E 6JN, United Kingdom

Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Newcastle Hospitals NHS Foundation Trust, Freeman Hospital

Newcastle NE7 7DN, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-07