ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Primary Plasma Cell Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous hematopoietic stem cell transplantation, BCMA CAR-T, GPRC5D/CD3 BiTEs.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma, Plasma Cell Leukemia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Single-Arm, Phase II Study of Autologous Stem Cell Transplantation Combined With BCMA CAR-T Therapy Followed by GPRC5D/CD3 Bispecific Antibody Maintenance in Transplant-Eligible Patients With Primary Plasma Cell Leukemia
Overview
This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of autologous stem cell transplantation combined with BCMA CAR-T therapy followed by GPRC5D/CD3 bispecific antibody maintenance in transplant-eligible patients with primary plasma cell leukemia.
Detailed description
All subjects will receive standard induction therapy for up to four cycles prior to screening. Following response evaluation, those who meet the inclusion criteria will be enrolled. Enrolled patients will undergo autologous stem cell transplantation (ASCT) combined with BCMA CAR-T cell therapy, followed by GPRC5D/CD3 bispecific antibody therapy.
Patients who achieve a stringent complete response (sCR) and sustained MRD negativity (≥12 months) will receive maintenance therapy for 24 months, and may then enter a treatment-free observation phase. Patients who experience MRD resurgence or loss of response during observation will resume maintenance therapy.
Patients who do not achieve both sCR and sustained MRD negativity (≥12 months) will continue GPRC5D/CD3 bispecific antibody therapy until disease progression or unacceptable toxicity.
Interventions
- Procedure Autologous hematopoietic stem cell transplantation
Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection. - Biological BCMA CAR-T
Patients will receive BCMA CAR-T single dose (3.0 x 10\^6 cells /kg) infusion 3 days after ASCT. - Drug GPRC5D/CD3 BiTEs
Patients will receive GPRC5D/CD3 BiTEs maintenance therapy at a dose of 54 μg/kg every 4 weeks, starting 3 months after BCMA CAR-T infusion and continuing for at least 2 years
Primary outcome measures
- Sustained MRD-negative rate [Time frame: Up to 2 year]
- MRD negativity rate [Time frame: Up to 2 years]
Secondary outcome measures (4)
- Safety and Tolerability [Time frame: Up to 2 year]
- Complete response rate (CRR) [Time frame: Up to 2 years]
- Progression free survival (PFS) [Time frame: Up to 3 year]
- Overall survival (OS) [Time frame: Up to 5 year]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years and ≤ 70 years.
- Participants with documented newly-diagnosed primary plasma cell leukemia according to IMWG diagnostic criteria.
- Measurable disease at screening, defined as: Serum M-protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
- Patients deemed eligible for high-dose chemotherapy with ASCT.
- Tumor cells were BCMA and GPRC5D positive.
- Serum total bilirubin <2 x upper limit of normal (ULN), serum AST and ALT <3 x ULN, creatinine clearance ≥ 30mL/min (Cockroft-Gault formula).
- Informed Consent/Assent: All subjects have the ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
- Active amyloidosis.
- Central nervous system involvement.
- Prior BCMA-targeted therapy or CAR-T therapy.
- Active hepatitis B or hepatitis C virus infection.
- Known HIV infection.
- Life expectancy <6 months.
- Woman who are pregnant or breastfeeding
- Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs.
- Any other conditions that are not eligible for the trial in the judgement of the principal investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin
Identifiers
NCT: NCT07106684 · IIT2025048