Place-of-care manufactured anti-BCMA chimeric antigen receptor (CAR) T-cells (ARI0002h) in patients with relapsed/refractory multiple myeloma.
Cell and Tissue Therapies WA, Royal Perth Hospital, East Metropolitan Health Service
15 participants
Feb 2, 2026
Interventional
Conditions
Summary
This study is testing a new type of treatment called ARI0002h, which is a Chimeric Antigen Receptor T-cell (CAR-T) therapy. The purpose is to see whether ARI0002h is safe and effective for people with multiple myeloma whose cancer has come back or not responded after standard treatments. Who is it for? This study may be suitable for adults aged 18 to 80 years who have multiple myeloma that has returned or is not responding to treatment after at least two prior lines of therapy, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 antibody. Participants need to have a reasonable general health (ECOG 0–2) and a life expectancy greater than 3 months. Study details All participants in this study will receive the investigational treatment ARI0002h. To create this therapy, a participant’s own T-cells (a type of immune cell) will be collected from the blood and modified in a laboratory to specifically target BCMA, a protein found on myeloma cells. Before receiving the therapy, participants will be given chemotherapy to prepare their body (lymphodepletion). Treatment with ARI0002h will then be given in three step-up doses over the course of one week. A second infusion may be given 3–4 months later if participants have shown at least some response, the disease has not progressed, and severe side effects such as high-grade cytokine release syndrome are not present. Blood tests and other assessments will be performed regularly to monitor safety and response. It is hoped that this study will show whether ARI0002h can help control multiple myeloma that has not responded to other treatments, and contribute to developing new treatment options for patients in the future.
Eligibility
Inclusion Criteria7
- Patients between 18 and 80 years old diagnosed with multiple myeloma,
- Disease measurable by serum or urine monoclonal component, or by serum free light chains, according to the eligibility criteria for clinical trials of the International Myeloma Working Group (IMWG) (Kumar, S., B. Paiva, et al. 2016).
- Having completed two or more prior lines of treatment and having received at least one proteasome inhibitor (such as bortezomib or carfilzomib), one immunomodulator (lenalidomide or pomalidomide) and one anti-CD38 monoclonal antibody (such as daratumumab).
- Refractory to the last line of treatment (defined as progression during treatment or within 60 days after the end of treatment).
- ECOG performance status from 0 to 2
- Life expectancy greater than 3 months.
- Patients who, after being informed, give their consent by signing the Informed Consent Document.
Exclusion Criteria12
- Prior allogeneic transplant in the 6 months prior to inclusion or GVHD requiring active systemic immunosuppressive treatment.
- Patients who have previously received any treatment with CART or with anti-BCMA antibodies.
- Absolute lymphocyte count 3 years and skin carcinomas (non-melanoma)
- Active infection requiring treatment.
- Active HIV, HBV, or HCV infection.
- Uncontrolled medical disease,
- Severe organ involvement that meets any of the following criteria: EF<40%, DLCO <40%, GFR 3 times the upper limit of normality (unless Gilbert syndrome)
- Previous diagnosis of symptomatic AL amyloidosis,
- Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at the screening phase.
- Women of childbearing potential, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective contraceptive methods from the beginning of the study to completion of the study.
- Men who are unable or unwilling to use highly effective contraceptive methods* from the beginning of the study to completion of the study.
- Contraindication to receive lymphodepletive chemotherapy.
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Interventions
ARI0002h is an autologous CAR-T cell product modified to specifically target BCMA on B cells. Leukapheresis for collection of the T cells is planned for 2-4 weeks prior to the infusion to allow for manufacturing of the ARI0002h. Five days prior to infusion of the ARI0002h cells, all patients will undergo lymphodepletive chemotherapy with fludarabine, given intravenously at 30mg/m^2/day, and cyclophosphamide, given intravenously at 300mg/m^2/day, for 3 consecutive days. ARI0002h will be given over a week with 3 separate intravenous infusions to make at a total dose of 3 x 10^6 CARTBCMA/kg. The dose of each infusion will be increased step-wise to minimise side effects (10% on day 0, 30% on day 3 and 60% on day 7 A second dose may be given between 3-4 months after the first dose consisting of one infusion at a total dose of 3 x 10^6 CARTBCMA/kg. The second dose of ARI0002h will only be given if some degree of response has been achieved (at least minimal response), without progression and in the absence of cytokine release syndrome grade III-IV. The intervention is given in hospital and will be recorded on the patient's electronic medical record. Adherence to dosing, per protocol, will be documented on chemotherapy and cell infusion charts in the participant's medical record. Prior to administration, both lymphodepletive chemotherapy and ARI0002h will be subject to a 2-person label check by appropriately qualified individuals. Response to treatment will be assessed using the International Myeloma Working Group criteria 2016.
Locations(1)
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ACTRN12625001031459