2025-524876-43-00Not yet recruitingPhase 3
A study investigating the safety and efficacy of academically-produced CAR T cells compared with standard treatment for patients with multiple myeloma whose disease has returned or not responded to previous treatments.
HO183 CAR T: A phase III randomized trial comparing academically produced BCMA-directed CAR T-cells (ARI0002h) with standard of care regimen in patients with relapsed/refractory multiple myeloma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Apr 2026
Brief summary (registry, in English)
To compare progression free survival (PFS) of patients randomized to PoC ARI0002h CAR T-cells versus current SoC in patients previously treated with 2-4 lines of therapy
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 19 Dec 2025
- Start date
- 1 Aug 2026
- Lead sponsor
- Universitair Medisch Centrum Groningen
- Diseases
- Multiple myeloma
- EU CT number
- 2025-524876-43-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 126
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple myeloma that came back or stopped responding after 2 to 4 earlier treatments. It compares ARI0002h CAR T-cells with standard treatment.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Multiple myeloma that no longer responds to the last treatment, with disease that can be measured at screening. ECOG/WHO performance status of 0-2.
- Earlier treatment
- Must have had 2 to 4 earlier lines of myeloma treatment, including an IMiD, a PI and an anti-CD38 antibody. Must not have had BCMA-targeted therapy, T-cell engager therapy, CAR T-cell therapy or other genetically modified T-cell therapy.
Main reasons for not taking part
- Myeloma in the brain, spinal fluid or heart
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or amyloidosis
- Uncontrolled infection or infection needing IV antimicrobials
- Pregnant or breastfeeding women, or people not willing to use highly effective birth control
- Life expectancy under 12 weeks, or taking part in another clinical trial
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received one of the following prior therapies: BCMA-targeted therapy, T-cell engager therapy, CAR T-cell therapy, or other genetically modified T-cell therapy
- Active or prior history of central nervous system (CNS) or meningeal involvement of MM
Other illness
- Cardiac atrial or cardiac ventricular MM involvement.
- History of or active plasma cell leukemia, Waldenstrom’s macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, or amyloidosis.
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
Other
- Females who are pregnant or breastfeeding
- Participants who are not willing to practice highly effective birth control
- Life expectancy < 12 weeks
- Current participation in another clinical trial
Who the study is looking for
- Documented historical diagnosis of Multiple Myeloma
- Received 2 to 4 prior lines of antimyeloma therapy, including an IMiD, a PI and an anti-CD38 mAb.
- Refractory to the last line of treatment by IMWG criteria
- Measurable disease at screening per IMWG criteria
- Candidates to receive at least 1 of the 5 SoC regimens (PVd, PCd, EPd, DKd or Kd)
- Aged 18 years or older
- Capable of giving informed consent
- ECOG/WHO performance status of 0-2
- Adequate hematological, renal, hepatic, pulmonary, and cardiac function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.