Multiple MyelomaPhase 2iMMagine-1NCT05396885
Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)
A Phase 2 study testing anitocabtagene-autoleucel in people with Multiple Myeloma, run by Kite, A Gilead Company at 18 sites in United States.
Trial summary
A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- anitocabtagene-autoleucel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 18 sitesUnited States
- Study dates
- 15 Jul 2022to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older and has capacity to give informed consent
- Relapsed or refractory multiple myeloma treated with at least 3 prior regimens of systemic therapy including proteasome inhibitor, immunomodulatory drugs (IMiD) and anti-CD38 antibody and are refractory to the last line of therapy. For each line, 2 consecutive cycles are required unless the best response after 1 cycle was progressive disease.
- Note: IMWG criteria defines refractory disease as non-responsive to therapy or disease progression on or within 60 days of a therapy Note: Induction treatment with or without hematopoietic stem cell transplant and with or without maintenance is considered a single regimen
- Documented measurable disease including at least one or more of the following criteria:
- Serum M-protein ≥1.0 g/dL
- Urine M-protein ≥200 mg/24 hours
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- Involved serum free light chain ≥10 mg/dL with abnormal κ/λ ratio (i.e., >4:1 or <1:2)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy >12 weeks
- Adequate organ function defined as:
- Oxygen (O2) saturation ≥92% on room air
- Left Ventricular Ejection Fraction (LVEF) ≥45% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
- Absolute neutrophil count (ANC) ≥1.0k/µl, platelet count (PLT)
- ≥50k/µl, [NOTE: Platelet transfusion not allowed within 14 days; filgrastim (or biosimilar) not allowed within 7 days, pegfilgrastim (or biosimilar) within 14 days]
- Creatinine clearance ≥45 mL/min min (as determined by the Cockgroft-Gault equation) and not on dialysis
- Aspartate transaminase (AST)/alanine transaminase (ALT) <3 x upper limits of normal (ULN)
- Total bilirubin <1.5 x ULN (allow 3x ULN for Gilbert's syndrome)
- Prothrombin time test (PTT), prothrombin time (PT)/international normalized ratio (INR) <1.5 x ULN, unless on a stable dose of anti-coagulant for a thromboembolic event (Subjects with any history of thromboembolic stroke; or history or Grade 2 (G2) or greater hemorrhage within one year are excluded)
- Resolution of adverse events (AEs) from any prior systemic anticancer therapy, radiotherapy, or surgery to Grade 1 or baseline (except G2 alopecia and G2 sensory neuropathy)
- Male and female participants of childbearing potential must agree to use highly effective methods of birth control through 12 months after the dose of study treatment
- Willing to comply with and able to tolerate study procedures, including consent to participate in separate Long-term Safety Follow-up lasting up to 15 years per FDA guidance
- Subject's leukapheresis product from non-mobilized cells is received and accepted for cell processing by manufacturing site. NOTE: Leukapheresis will be performed only after all other eligibility criteria are confirmed
Who cannot join
- Plasma cell leukemia or history of plasma cell leukemia
- Treatment with the following therapies as specified below
- Any prior systemic treatment for multiple myeloma within the 14 days prior to scheduled leukapheresis
- Receiving high-dose (e.g., >10 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to leukapheresis
- Prior treatment with any gene therapy, gene-modified cellular immune-therapy, or T cell engager
- Prior B-cell maturation antigen (BCMA) directed therapy
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- Autologous stem cell transplantation within 3 months prior to leukapheresis, or any prior allogeneic stem cell transplantation
- Subjects with solitary plasmacytomas without evidence of other measurable disease are excluded
- History of allergy or hypersensitivity to study drug components. Subjects with a history of severe hypersensitivity reaction to dimethyl sulphoxide (DMSO) are excluded
- Contraindication to fludarabine or cyclophosphamide
- Severe or uncontrolled intercurrent illness or laboratory abnormalities including
- Active bacterial, viral, or fungal infection requiring systemic treatment (isolated fever may not constitute active infection in and of itself, (e.g., related to disease)
- Symptomatic congestive heart failure (i.e., New York Heart Association stage III or IV)
- Unstable angina, arrhythmia, or myocardial infarction (MI) within 6 months prior to Screening
- Significant pulmonary dysfunction
- Uncontrolled thromboembolic events or recent severe hemorrhage (i.e., within one year)
- Any history of pulmonary embolism (PE) in the past 12 months or deep vein thrombosis (DVT) within three months of enrollment. Therapeutic dosing of anticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors) is allowed for history of PE/DVT if greater than twelve and three months, respectively, from time of enrollment, and should be at a stable maintenance dose.
- Auto-immune disease requiring immunosuppressive therapy within the last 24 months
- Seropositive for and with evidence of active hepatitis B or C infection at time of Screening, or HIV seropositive
- Subjects with a history of hepatitis B but have received antiviral therapy and have non-detectable viral DNA are eligible
- Subjects seropositive because of hepatitis B virus vaccine with no signs or active infection are eligible
- Subjects who had hepatitis C but have received antiviral therapy and show no detectable hepatitis C virus (HCV) viral RNA are eligible
- Active central nervous system (CNS) involvement by malignancy
- Any sign of active or prior CNS pathology including but not limited to history of epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed, severe brain injury, dementia, cerebellar disease, Parkinson's disease, organic brain syndrome or psychosis
- Active malignancy not related to myeloma that has required therapy in the last 3 years or is not in complete remission. Exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy.
- Females who are pregnant or breastfeeding or females of childbearing potential not using an effective method of birth control
- Subjects with any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in study (or full access to medical records) as written including follow up, the interpretation of data or place the subject at unacceptable risk
- Any vaccine ≤ 6 weeks before leukapheresis and/or anticipation of the need for such a vaccine during the subject's participation in the study
- Concurrent enrollment on another study using an investigational therapy for the treatment of RRMM
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Northside Hospital
Atlanta, Georgia, 30342
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Karmanos Cancer Institute
Detroit, Michigan, 48201
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
HonorHealth Cancer Transplant Institute
Scottsdale, Arizona, 85258
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase II Study of CART-ddBCMA for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy.
Read the detailed description
This is a Phase II open-label study of anitocabtagene-autoleucel * in patients with relapsed or refractory multiple myeloma (MM). The study will have the following sequential phases: screening, enrollment, pre-treatment with lymphodepleting chemotherapy, treatment with anitocabtagene-autoleucel , and follow-up. If necessary, bridging therapy is allowed to control growth of MM disease while anitocabtagene-autoleucel is being manufactured.
Following a single infusion of anitocabtagene-autoleucel both safety and efficacy data will be assessed. Efficacy will be assessed monthly for the first 6 months, then quarterly up to 2 years, or upon patient relapse. The primary analysis will be conducted approximately 13 months after the final patient is dosed. This will allow approximately 12 months follow up from the time of the last observed response on study.
Long-term safety data will be collected under a separate long-term follow up study for up to 15 years per health authority guidelines.
*Anitocabtagene-autoleucel drug product consists of autologous T cells that have been genetically modified ex vivo to express a D-domain Chimeric Antigen Receptor (CAR), followed by a cluster of differentiation 8 (CD8) hinge and transmembrane region that is fused to the intracellular signaling domains for 4-1BB and CD3ξ, that specifically recognizes B-cell maturation antigen (BCMA). The active substance of anitocabtagene-autoleucel is CAR+ CD3+ T cells that have undergone ex vivo T-cell activation, gene transfer by replication-deficient lentiviral vector, and expansion.
- Conditions
- Multiple Myeloma
- Being tested
- anitocabtagene-autoleucel
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anitocabtagene-autoleucelBiological
Also called CART-ddBCMA
Anitocabtagene-autoleucel-directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-domain
| Study group | Role | What they receive |
|---|---|---|
| anitocabtagene-autoleucel | Experimental | Single dose of 115±10 x 10e-6 CAR+ anitocabtagene-autoleucel cells infused intravenously Receives: Biological: anitocabtagene-autoleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR Per International Myeloma Working Group (IMWG) criteria, as assessed by an independent review committee (IRC)
Measured: 24 Months
Secondary outcomes (13)
Stringent complete response (sCR) or complete response (CR) rate
The proportion of participants in whom best response of sCR or CR,as assessed by an independent review committee (IRC) per by IMWG criteria
Measured: 24 Months
Overall Response Rate (ORR) of participants limited to three lines of prior treatment
ORR per IMWG criteria, as assessed by an independent review committee (IRC), of participants limited to three lines of prior treatment
Measured: 24 Months
Duration of Response (DoR)
DoR is defined as the time from the date of first documentation of response of PR or better per IMWG criteria after anitocabtagene-autoleucel infusion to the earlier of first documentation of disease progression per IMWG criteria or death
Measured: 24 Months
Very Good Partial Response (VGPR) Rate and Partial Response (PR) Rate
The proportion of participants with best response of VGPR and PR, respectively, by IMWG criteria
Measured: 24 Months
Time to Initial Response
Time to initial response is defined as the measurement of time from the date of infusion of anitocabtagene-autoleucel to the date upon which the first IMWG response (i.e., PR or better) occurs
Measured: 24 months
Progression Free Survival (PFS)
PFS is defined as the measurement of time from the date of infusion of anitocabtagene-autoleucel to the date upon which the IMWG criteria for progressive disease or death occurs
Measured: 24 Months
Overall Survival (OS)
OS is defined as the measurement of time (e.g., days or months) from the date of infusion of anitocabtagene-autoleucel to the date upon which death from any cause occurs
Measured: 24 Months
Safety Profile of anitocabtagene-autoleucel as assessed by incidence and severity of adverse events
Summarization of adverse event (AE) terms, frequency, and severity using CTCAE version 5.0, the adverse events of special interest (AESIs), the serious adverse events (SAEs)
Measured: 24 Months
Pharmacokinetics of anitocabtagene-autoleucel
Pharmacokinetics of anitocabtagene-autoleucel is defined as the using vector copy number (VCN) on peripheral mononuclear cells at defined timepoints. Quantification of anitocabtagene-autoleucel cells using vector copy number (VCN) on peripheral blood mononuclear cells
Measured: 24 Months
Anti-anitocabtagene-autoleucel Antibodies
Proportion of participants who develop antibodies against anitocabtagene-autoleucel and the timing and titer of antibodies developed
Measured: 24 Months
Health Related Quality of Life (HRQoL)
Measure the change in HRQoL pre- versus post-treatment with anitocabtagene-autoleucel
Measured: 24 Months
Minimal Residual Disease (MRD) negativity
The proportion of participants that are MRD negative (i.e., no measurable tumor cells in at least 105 cells isolated from the bone marrow) from the efficacy evaluable (EE) population and from the MRD evaluable population (i.e., those participants with baseline sample allowing MRD calibration)
Measured: 24 Months
Time to Progression (TTP)
TTP is defined as the measurement of time from date of anitocabtagene-autoleucel infusion to first documented IRC assessed progression using IMWG criteria or death due to disease progression
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start15 Jul 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Kite, A Gilead CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kite, A Gilead Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arcellx, Inc.
- Responsible party
- Sponsor
- Investigators
- Arcellx, Inc., Study director, Arcellx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396885
- Sponsor's protocol ID
- ARC-112A
- Acronym
- iMMagine-1
- Status last verified
- Feb 2026
- First submitted
- 12 May 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of CART-ddBCMA for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05396885
- Acronym / sponsor ID
- iMMagine-1 / ARC-112A
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Kite, A Gilead CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Arcellx, Inc.
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy.
Detailed description
This is a Phase II open-label study of anitocabtagene-autoleucel * in patients with relapsed or refractory multiple myeloma (MM). The study will have the following sequential phases: screening, enrollment, pre-treatment with lymphodepleting chemotherapy, treatment with anitocabtagene-autoleucel , and follow-up. If necessary, bridging therapy is allowed to control growth of MM disease while anitocabtagene-autoleucel is being manufactured.
Following a single infusion of anitocabtagene-autoleucel both safety and efficacy data will be assessed. Efficacy will be assessed monthly for the first 6 months, then quarterly up to 2 years, or upon patient relapse. The primary analysis will be conducted approximately 13 months after the final patient is dosed. This will allow approximately 12 months follow up from the time of the last observed response on study.
Long-term safety data will be collected under a separate long-term follow up study for up to 15 years per health authority guidelines.
*Anitocabtagene-autoleucel drug product consists of autologous T cells that have been genetically modified ex vivo to express a D-domain Chimeric Antigen Receptor (CAR), followed by a cluster of differentiation 8 (CD8) hinge and transmembrane region that is fused to the intracellular signaling domains for 4-1BB and CD3ξ, that specifically recognizes B-cell maturation antigen (BCMA). The active substance of anitocabtagene-autoleucel is CAR+ CD3+ T cells that have undergone ex vivo T-cell activation, gene transfer by replication-deficient lentiviral vector, and expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anitocabtagene-autoleucel | Experimental | Biological: anitocabtagene-autoleucelSingle dose of 115±10 x 10e-6 CAR+ anitocabtagene-autoleucel cells infused intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age 18 years or older and has capacity to give informed consent
- Relapsed or refractory multiple myeloma treated with at least 3 prior regimens of systemic therapy including proteasome inhibitor, immunomodulatory drugs (IMiD) and anti-CD38 antibody and are refractory to the last line of therapy. For each line, 2 consecutive cycles are required unless the best response after 1 cycle was progressive disease.
- Note: IMWG criteria defines refractory disease as non-responsive to therapy or disease progression on or within 60 days of a therapy Note: Induction treatment with or without hematopoietic stem cell transplant and with or without maintenance is considered a single regimen
- Documented measurable disease including at least one or more of the following criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (29 listed)
- Plasma cell leukemia or history of plasma cell leukemia
- Treatment with the following therapies as specified below
- Subjects with solitary plasmacytomas without evidence of other measurable disease are excluded
- History of allergy or hypersensitivity to study drug components. Subjects with a history of severe hypersensitivity reaction to dimethyl sulphoxide (DMSO) are excluded
- Contraindication to fludarabine or cyclophosphamide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anitocabtagene-autoleucelAlso: CART-ddBCMAAnitocabtagene-autoleucel-directed CAR T-cell therapy using a novel, synthetic binding domain, called a D-domain | Biological | anitocabtagene-autoleucel |
Primary outcome
Overall Response Rate (ORR)
Time frame: 24 Months
ORR Per International Myeloma Working Group (IMWG) criteria, as assessed by an independent review committee (IRC)
13 secondary outcomes
Stringent complete response (sCR) or complete response (CR) rate
Time frame: 24 Months
Overall Response Rate (ORR) of participants limited to three lines of prior treatment
Time frame: 24 Months
Duration of Response (DoR)
Time frame: 24 Months
Very Good Partial Response (VGPR) Rate and Partial Response (PR) Rate
Time frame: 24 Months
Time to Initial Response
Time frame: 24 months
Progression Free Survival (PFS)
Time frame: 24 Months
Overall Survival (OS)
Time frame: 24 Months
Safety Profile of anitocabtagene-autoleucel as assessed by incidence and severity of adverse events
Time frame: 24 Months
Pharmacokinetics of anitocabtagene-autoleucel
Time frame: 24 Months
Anti-anitocabtagene-autoleucel Antibodies
Time frame: 24 Months
Health Related Quality of Life (HRQoL)
Time frame: 24 Months
Minimal Residual Disease (MRD) negativity
Time frame: 24 Months
Time to Progression (TTP)
Time frame: 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arcellx, Inc. study director
Arcellx, Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anitocabtagene-autoleucel in people with Multiple Myeloma, run by Kite, A Gilead Company at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.