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.
Key facts
- Where
- Groningen, HollandiaSee the site
- Phase
- 3. fázis
Where in Hollandia
- Universitair Medisch Centrum GroningenGroningen, HollandiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitair Medisch Centrum Groningen
- Trial code
- EU 2025-524876-43-00
- Record updated
- 2026. április 29.
- Original description
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 therapyRead full original descriptionShow less
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
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
Inclusion: 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.
Exclusion: 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; 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; 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.