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Clinical trial for the use of a humanized CART directed against BCMA (ARI0002h) in patients with newly diagnosed primary plasma cell leukemia.
EU CTIS ID: 2024-515053-21-00
What this study is testing
To assess the safety and efficacy of CARTBCMA ARI0002h (Cesnicabtagene autoleucel) after initial treatment to induce response in patients with newly diagnosed primary plasma cell leukaemia.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients between 18 and 75 years old diagnosed with newly diagnosed primary plasma cell leukemia (the presence of 5% or more circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic multiple myeloma), according to International Myeloma Working Group (IMWG). In order to confirm this inclusion criteria, two peripheral blood slides of the diagnostic will be sent to the coordinating team at HCB. In the event that a diagnostic slide is unavailable, a document confirming the diagnostic results must be provided instead.
- Disease measurable at diagnosis by monoclonal component in serum or urine, or by free light chains in serum according to the eligibility criteria for clinical trials of the "International Myeloma Working Group".
- ECOG Performance Status from 0 to 1
- Life expectancy greater than 3 months
- Adequate venous access and absence of contraindications for lymphoapheresis
- Patients who, after being informed, give their consent by signing the Informed Consent Document.
You likely can't join if
- No previous treatments, except for induction therapy for primary plasma cell leukemia.
- Severe organ impairment that meets any of the following criteria: EF<40%, DLCO <40%, GFR <30 ml/min, bilirubin >3 times the upper limit of normality (unless due to 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.
See the full eligibility criteria
Who can join
- Patients between 18 and 75 years old diagnosed with newly diagnosed primary plasma cell leukemia (the presence of 5% or more circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic multiple myeloma), according to International Myeloma Working Group (IMWG). In order to confirm this inclusion criteria, two peripheral blood slides of the diagnostic will be sent to the coordinating team at HCB. In the event that a diagnostic slide is unavailable, a document confirming the diagnostic results must be provided instead.
- Disease measurable at diagnosis by monoclonal component in serum or urine, or by free light chains in serum according to the eligibility criteria for clinical trials of the "International Myeloma Working Group".
- ECOG Performance Status from 0 to 1
- Life expectancy greater than 3 months
- Adequate venous access and absence of contraindications for lymphoapheresis
- Patients who, after being informed, give their consent by signing the Informed Consent Document.
What rules you out
- No previous treatments, except for induction therapy for primary plasma cell leukemia.
- Severe organ impairment that meets any of the following criteria: EF<40%, DLCO <40%, GFR <30 ml/min, bilirubin >3 times the upper limit of normality (unless due to 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.
- Administration of any anti-BCMA therapy as part of induction
- Not having achieved at least a minimal response with induction treatment (IMWG criteria)
- Absolute lymphocyte count <0.1x109/L
- Active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent)
- Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma.
- Active infection requiring treatment.
- Active HIV, HBV, or HCV infection.
- Uncontrolled medical illness.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.