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RecruitingPhase 2NCT07106684

ASCT Combined With BCMA CAR-T and GPRC5D/CD3 BiTEs Maintenance for Transplant-Eligible Primary Plasma Cell Leukemia

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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

20 participants

Start Date

Aug 10, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma, Plasma Cell Leukemia

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

  • 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 Criteria9

  • 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.

Interventions

PROCEDUREAutologous hematopoietic stem cell transplantation

Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection.

BIOLOGICALBCMA CAR-T

Patients will receive BCMA CAR-T single dose (3.0 x 10\^6 cells /kg) infusion 3 days after ASCT.

DRUGGPRC5D/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

Locations(1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT07106684