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RecruitingLast updated: 25 February 2025

iMMagine-3: This study is recruiting people with relapsed or refractory multiple myeloma (RRMM) to investigate whether CAR-T cell therapy is more effective than standard treatmentA Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

iMMagine-3

Clinical summary

Summary

This study is investigating whether anitocabtagene autoleucel provides better outcomes than standard treatments for people with relapsed/refractory multiple myeloma, focusing on how long participants remain disease-free after treatment.

Anitocabtagane autoleucel is a CAR-T cell therapy, which is a type of immunotherapy that uses genetically modified T-cells to fight cancer.

Eligible participants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive intravenous lymphodepletion chemotherapy with cyclophosphamide and fludarabine for 3 days followed by single dose of anitocabtagene autoleucel chimeric antigen receptor positive (CAR+) on Day 1.

In the Active Comparator Arm, participants will receive the Investigator's choice of one of the following therapies:

  • Pomalidomide, bortezomib, and dexamethasone (PVd) (21-day cycles);
  • Daratumumab, pomalidomide, and dexamethasone (DPd) (28-day cycles);
  • Carfilzomib, daratumumab, and dexamethasone (KDd) (28-day cycles); or
  • Carfilzomib and dexamethasone (Kd) (28-day cycles).

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

Conditions

This trial is treating people with multiple myeloma who have received 1 to 3 prior lines of treatment

Eligibility

Inclusion

  • 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)

Exclusion

  • 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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Kite, A Gilead Company

Scientific Title

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

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