Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing anti-BCMA CAR-T for Plasma Cell Leukemia

This is a single-arm, open-label study to measure the how well it works and safety of VRD-based regimen combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia

Official registry: https://clinicaltrials.gov/study/NCT05979363 · Institute of Hematology & Blood Diseases Hospital, China · enrollment listed as 20

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are anti-BCMA CAR-T, or VRD-based regimen. The registry lists allocation as na. This is a single-arm, open-label study to measure the how well it works and safety of VRD-based regimen combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia

They plan to enroll about 20 people at Tianjin. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

Safety and Efficiency of VRd-based Regimen Combining BCMA CAR-T for Transplant-ineligible Patients With Primary Plasma Cell Leukemia: a Prospective, Single-arm, Single-center, Phase II Study.

Interventions: anti-BCMA CAR-T, VRD-based regimen

Primary outcome (registry wording): Safety and Tolerability

Who it is for (from inclusion criteria)

  • Ages 18 Years to 75 Years
  • Age ≥ 18 years and ≤ 75 years
  • Participants with documented primary plasma cell leukemia according to IMWG diagnostic criteria (circulating plasma cells ≥5%, determined by morphology on peripheral blood smear; or absolute value of peripheral blood tumorigenic plasma cells exceeds 2×10\^9/L)
  • Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination
  • Patients must be able to take prophylactic anticoagulant therapy as recommended by the study
  • The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter

Public study contact (from the registry)

Gang An, PhD&MD

86-022-23909171

angang@ihcams.ac.cn

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT05979363 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05979363?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05979363?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary