A Trial to Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Standard of Care in Newly Diagnosed Multiple Myeloma

NCT07887672 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: KT-US-715-07902026-527198-12-00
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical study iMMagine-4 is to compare and assess the safety and effectiveness of anitocabtagene autoleucel versus standard of care therapy (SOCT) in participants with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus quadruplet-based SOCT in participants with NDMM who are not eligible for autologous stem cell transplant (auto-SCT).

Conditions

Newly Diagnosed Multiple Myeloma

Keywords

Multiple Myeloma; CAR-T; ddBCMA; BCMA

Outcome Measures

Primary Outcomes (2)

• Minimal Residual Disease (MRD)-Negative Complete Response (CR) or Stringent CR (sCR) Rate at 12 Months

  Minimal residual disease (MRD)-negative CR/sCR is defined as the proportion of participants achieving CR/sCR and MRD-negative status (10\^5 cutoff) at 12 months. CR/sCR per International Myeloma Working Group (IMWG) criteria is determined by the Independent Review Committee (IRC).

  12 months

• Progression-Free Survival (PFS)

  PFS is defined as the time from randomization to the first documented disease progression per International Myeloma Working Group (IMWG) criteria as determined by the Independent Review Committee (IRC), or death due to any cause, whichever occurs first.

  Up to 15 years

Secondary Outcomes (18)

• Overall survival (OS)

  Up to 15 years

• Overall Response Rate (ORR)

  Up to 15 years

• Rate of Very Good Partial Response or Better

  Up to 15 years

• Rate of CR or Better

  Up to 15 years

• Time to Response (TTR)

  Up to 15 years

Study Arms (2)

Arm A: Standard of Care Therapy (SOCT)

ACTIVE COMPARATOR

Participants will receive a total of eight induction therapy cycles, 21-days for each cycle, with daratumumab, bortezomib, lenalidomide and dexamethasone. Following induction, participants will receive maintenance therapy during 28-day cycles of daratumumab, lenalidomide and dexamethasone, until unacceptable toxicity, progression as per IMWG criteria, death, or participant withdrawal of consent (whichever occurs first).

Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone

Arm B: Anitocabtagene Autoleucel

EXPERIMENTAL

Participants will receive a total of eight induction therapy cycles, 21-days for each cycle, with daratumumab, bortezomib, lenalidomide and dexamethasone. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine for 3 days, followed by a single infusion of anitocabtagene autoleucel. If specific criteria are met, some participants may receive maintenance therapy (at or after Month 6 post-anitocabtagene autoleucel infusion) during 28-day cycles of daratumumab, lenalidomide and dexamethasone, until unacceptable toxicity, progression as per IMWG criteria, death, or participant withdrawal of consent (whichever occurs first).

Drug: Anitocabtagene autoleucel; Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

Daratumumab DRUG

Administered subcutaneously (SC)

Arm A: Standard of Care Therapy (SOCT); Arm B: Anitocabtagene Autoleucel

Bortezomib DRUG

Administered SC

Arm A: Standard of Care Therapy (SOCT); Arm B: Anitocabtagene Autoleucel

Lenalidomide DRUG

Administered orally (PO)

Arm A: Standard of Care Therapy (SOCT); Arm B: Anitocabtagene Autoleucel

Dexamethasone DRUG

Administered PO or intravenously (IV)

Arm A: Standard of Care Therapy (SOCT); Arm B: Anitocabtagene Autoleucel

Fludarabine DRUG

Administered IV

Arm B: Anitocabtagene Autoleucel

Cyclophosphamide DRUG

Administered IV

Arm B: Anitocabtagene Autoleucel

Anitocabtagene autoleucel DRUG

A single infusion of CAR+ transduced autologous T cells

Also known as: CART-ddBCMA

Arm B: Anitocabtagene Autoleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Determined by the Investigator to be not eligible for auto-SCT
• Documented newly diagnosed multiple myeloma (NDMM) according to IMWG diagnostic criteria
• Measurable disease at screening per IMWG:
• Serum M-protein level ≥ 1.0 g/dL; or
• Urine M-protein level ≥ 200 mg/24 hours; or
• Serum free light chain (FLC) ≥ 10 mg/dL (100 mg/L) and abnormal serum FLC ratio
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Adequate hematological function
• Adequate renal, hepatic, pulmonary, and cardiac function

You may not qualify if:

• Any prior anti-MM therapy (including B-cell maturation antigen (BCMA)-directed therapy, CAR T-cell therapy, or genetically modified cells), with the exception of protocol-specified anti-MM stabilizing therapy and palliative radiation
• Central nervous system (CNS) or meningeal involvement of MM
• History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or amyloidosis
• Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months.
• Prior allogeneic stem cell transplant
• Any prior systemic treatment or radiotherapy treatment for any cancer other than MM within 24 months before randomization.
• Live vaccine ≤ 4 weeks before randomization
• Presence or suspicion of infection that is uncontrolled
• History or presence of intracranial or CNS disorders, or CNS neoplasms (benign and malignant)
• Females who are pregnant or breastfeeding
• Females of childbearing potential who are not willing to use a highly effective method of contraception from the time of informed consent through the protocol-specified duration
• Contraindication to fludarabine or cyclophosphamide
• History of allergy or hypersensitivity to any trial agent or trial drug components
• Life expectancy \< 12 weeks

Sponsors & Collaborators

• Kite, A Gilead Company: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab; Bortezomib; Lenalidomide; Dexamethasone; fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Study Officials

• Kite Study Director

  Kite, A Gilead Company

  STUDY CHAIR

Central Study Contacts

Medical Information

CONTACT

844-454-5483(1-844-454-KITE); medinfo@kitepharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): February 1, 2042
• Study Completion (Estimated): February 1, 2042
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share