110 Participants Needed

CART-ddBCMA for Multiple Myeloma

(iMMagine-1 Trial)

Recruiting at 19 trial locations
CC
JB
CI
Overseen ByClinical Information
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called anitocabtagene-autoleucel for patients whose multiple myeloma has returned or not responded to other treatments. The treatment uses the patient's own immune cells, which are modified to better attack the cancer cells.

Will I have to stop taking my current medications?

The trial requires that you stop any systemic treatment for multiple myeloma and high-dose steroid therapy at least 14 days before a specific procedure called leukapheresis. If you are on these medications, you will need to stop them before participating.

What makes the CART-ddBCMA treatment unique for multiple myeloma?

CART-ddBCMA is a novel treatment for multiple myeloma that uses a synthetic antigen-binding domain to target BCMA, aiming to reduce immune reactions and improve stability. It is administered as a single dose after chemotherapy and has shown promising results with a high rate of complete responses in patients who have tried multiple other treatments.12345

What data supports the effectiveness of the treatment CART-ddBCMA for Multiple Myeloma?

Research shows that BCMA-targeting CAR T-cells, like CART-ddBCMA, are powerful treatments for multiple myeloma, with studies indicating they can lead to significant tumor reduction and improved patient responses. Additionally, similar treatments have shown promise in early trials, suggesting potential effectiveness in managing this condition.678910

Who Is on the Research Team?

TW

Tim Welliver, MD, PhD

Principal Investigator

Arcellx, Inc.

Are You a Good Fit for This Trial?

Adults with relapsed or refractory multiple myeloma who have tried at least three prior treatments, including proteasome inhibitors, IMiDs, and anti-CD38 antibodies. They must show measurable disease signs, be in good physical condition (ECOG 0-1), have a life expectancy over 12 weeks, and proper organ function. Participants should not be pregnant or breastfeeding and must agree to use effective birth control for a year post-treatment.

Inclusion Criteria

My multiple myeloma has not responded to 3 types of treatments including a proteasome inhibitor, IMiD, and anti-CD38 antibody.
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, 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, 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

Exclusion Criteria

I have or had 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 or gene-modified cellular immune-therapy, Prior B-cell maturation antigen (BCMA) directed therapy, 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants are enrolled and prepared for treatment

1-2 weeks

Pre-treatment

Participants receive lymphodepleting chemotherapy before CAR-T cell infusion

1 week

Treatment

Single infusion of anitocabtagene-autoleucel is administered

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and efficacy monthly for the first 6 months, then quarterly up to 2 years

24 months

Long-term follow-up

Long-term safety data collection for up to 15 years

15 years

What Are the Treatments Tested in This Trial?

Interventions

  • CART-ddBCMA
Trial Overview The trial is testing CART-ddBCMA, which is a type of CAR-T cell therapy targeting BCMA on cancer cells. It's for patients whose multiple myeloma has returned after treatment or hasn't responded to standard therapies. The study will assess the safety and effectiveness of this new intervention.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: anitocabtagene-autoleucelExperimental Treatment1 Intervention

CART-ddBCMA is already approved in United States for the following indications:

🇺🇸
Approved in United States as anitocabtagene-autoleucel for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kite, A Gilead Company

Lead Sponsor

Trials
45
Recruited
4,300+

Multiple Myeloma Research Foundation

Collaborator

Trials
11
Recruited
3,600+

Arcellx, Inc.

Industry Sponsor

Trials
5
Recruited
650+

Published Research Related to This Trial

B-cell maturation antigen (BCMA) CAR T cells are emerging as a highly effective treatment for multiple myeloma, showing promise for inclusion in first-line therapy based on clinical and preclinical data.
Advancements in patient stratification through genomic analysis and improvements in CAR T-cell manufacturing are enhancing early diagnosis, management of side effects, and overall access to this innovative treatment.
CAR T-Cell Therapy in Multiple Myeloma: Mission Accomplished?Rasche, L., Hudecek, M., Einsele, H.[2023]
In a study involving 50 primary multiple myeloma (MM) samples, all expressed B-cell maturation antigen (BCMA), and 78% also expressed TACI, suggesting that targeting both antigens could enhance treatment effectiveness.
The engineered APRIL-based CAR (ACAR) demonstrated significant tumor-killing ability against both BCMA and TACI expressing cells, achieving up to 72.9% killing of primary MM cells, and showed potential to control tumors even in the presence of BCMA-targeting antibodies, indicating a promising strategy to prevent tumor escape.
An APRIL-based chimeric antigen receptor for dual targeting of BCMA and TACI in multiple myeloma.Lee, L., Draper, B., Chaplin, N., et al.[2023]
Patients with multiple myeloma who do not respond to existing therapies have limited survival, but new treatments like CAR T-lymphocytes, bispecific antibodies, and antibody-drug conjugates are showing promise in early trials.
Idecabtagene vicleucel (ide cel) and belantamab mafodotin (belamaf) have been approved for use in relapsed/refractory multiple myeloma based on positive results from phase 2 studies, indicating their potential effectiveness in this challenging patient population.
Chimeric antigen receptor T-cells, bispecific antibodies, and antibody-drug conjugates for multiple myeloma: An update.Lakshman, A., Kumar, SK.[2022]

Citations

CAR T-Cell Therapy in Multiple Myeloma: Mission Accomplished? [2023]
An APRIL-based chimeric antigen receptor for dual targeting of BCMA and TACI in multiple myeloma. [2023]
Chimeric antigen receptor T-cells, bispecific antibodies, and antibody-drug conjugates for multiple myeloma: An update. [2022]
Anti-BCMA/CD19 CAR T Cells with Early Immunomodulatory Maintenance for Multiple Myeloma Responding to Initial or Later-Line Therapy. [2023]
Long-Term Follow-Up of Combination of B-Cell Maturation Antigen and CD19 Chimeric Antigen Receptor T Cells in Multiple Myeloma. [2022]
Phase 1 study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma. [2023]
Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. [2023]
Comparison of Cilta-cel, an Anti-BCMA CAR-T Cell Therapy, Versus Conventional Treatment in Patients With Relapsed/Refractory Multiple Myeloma. [2022]
Comparative Efficacy of Ciltacabtagene Autoleucel in CARTITUDE-1 vs Physician's Choice of Therapy in the Long-Term Follow-Up of POLLUX, CASTOR, and EQUULEUS Clinical Trials for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Cilta-cel OK'd for Multiple Myeloma. [2022]
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