BCMA-targeted LCAR-BCDR Cells in Patients With Relapsed/Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Sep 16, 2026
  • participants needed
    32
  • sponsor
    Weijun Fu
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Updated on 7 October 2022
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Summary

This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCDR cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy.

Details
Condition Relapsed/Refractory Multiple Myeloma
Treatment LCAR-BCDR cells product
Clinical Study IdentifierNCT05376345
SponsorWeijun Fu
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease
Subjects ≥ 18 years of age
Documented initial diagnosis of MM according to IMWG diagnostic criteria
Presence of measurable disease at screening
Received a PI and an IMiD (except thalidomide)
Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible
Expected survival ≥ 3 months
Clinical laboratory values meet screening visit criteria
Fertile women must be negative using a highly sensitive serum pregnancy test (β human chorionic gonadotropin [β -HCG]) at screening time and before initial treatment with cyclophosphamide and fludarabine

Exclusion Criteria

No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment)
Prior treatment with any antibody targeting BCMA
Diagnosed or pretreated for an invasive malignancy other than multiple myeloma
Prior anti-tumor treatment (before pretreatment) with insufficient washout period
Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma
Positive of any hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), human immunodeficiency virus antibody (HIV-Ab) at the time of screening
Serious underlying medical conditions
Male subjects who have a birth plan during the study period or within 1 year after the study treatment
Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment
The investigator considered that the subjects were not suitable for any conditions of participation in the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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