Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)
18 Years and older, Male and Female
ARC-112A (primary)
NCI-2022-10407
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.
Objectives
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 CD3?, 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.
Eligibility
- 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 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
- Involved serum free light chain =10 mg/dL with abnormal ?/? 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
Treatment Sites in Georgia
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.