Autologous genetically modified T lymphocytes transduced with lentivirus expressing CAR protein directed against BCMA for Relapsed/refractory multiple myeloma

Inclusion criteria

• {"criterion_text":"- Documented historical diagnosis of Multiple Myeloma\n- Received 2 to 4 prior lines of antimyeloma therapy, including an IMiD, a PI and an anti-CD38 mAb.\n- Refractory to the last line of treatment by IMWG criteria\n- Measurable disease at screening per IMWG criteria\n- Candidates to receive at least 1 of the 5 SoC regimens (PVd, PCd, EPd, DKd or Kd)\n- Aged 18 years or older\n- Capable of giving informed consent\n- ECOG/WHO performance status of 0-2\n- Adequate hematological, renal, hepatic, pulmonary, and cardiac function"}

Exclusion criteria

• {"criterion_text":"- 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\n- Active or prior history of central nervous system (CNS) or meningeal involvement of MM\n- Cardiac atrial or cardiac ventricular MM involvement.\n- History of or active plasma cell leukemia, Waldenstrom’s macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, or amyloidosis.\n- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.\n- Females who are pregnant or breastfeeding\n- Participants who are not willing to practice highly effective birth control\n- Life expectancy < 12 weeks\n- Current participation in another clinical trial"}

Primary endpoints

• {"endpoint_text":"- Progression free survival","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Safety and toxicity of ARI0002h CAR T-cells and SoC","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall response rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall and sustained MRD-negativity","definition_or_measurement_approach":""}
• {"endpoint_text":"- MRD-negative CR/sCR and MRD-negative VGPR+","definition_or_measurement_approach":""}
• {"endpoint_text":"- Correlation of MRD-negativity with efficacy endpoints","definition_or_measurement_approach":""}
• {"endpoint_text":"- Best overall response","definition_or_measurement_approach":""}
• {"endpoint_text":"- Duration of response","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival from date of randomization","definition_or_measurement_approach":""}
• {"endpoint_text":"- Patient Reported Outcome/Quality of Life","definition_or_measurement_approach":""}
• {"endpoint_text":"- CAR T-cell expansion, persistence, and T-cell characteristics in ARI0002h-treated patients","definition_or_measurement_approach":""}
• {"endpoint_text":"- PoC CAR T-cell production characteristics","definition_or_measurement_approach":""}
• {"endpoint_text":"- The association of the functional characteristics of the CAR T-cell products with CAR T-cell expansion, persistence, AEs, response rates and PFS","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of successful batches","definition_or_measurement_approach":""}
• {"endpoint_text":"- Production and additional health care costs","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

29

Number Of Sites

1

Number Of Participants

126

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"Spain","full_name":"Hospital Clinic De Barcelona","duties_or_roles":"CAR T cell production","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Netherlands","full_name":"Universitair Medisch Centrum Groningen","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Netherlands","full_name":"Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting","duties_or_roles":"1,10,12,5,6,7,8","organisation_type":"Patient organisation/association"}