Treatment for patients with relapsed or refractory multiple myeloma using LCAR-BCDR cells

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of LCAR-BCDR cell preparations in patients with relapsed or refractory multiple myeloma who have previously undergone standard therapies. It is a single-arm, open-label study designed to determine the appropriate dosing and to assess the anti-tumor efficacy of the treatment. Participants will be monitored for safety and tolerability throughout the trial. The study aims to provide new therapeutic options for patients who have limited treatment alternatives.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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;
2. Subjects ≥ 18 years of age.
3. Documented initial diagnosis of MM according to IMWG diagnostic criteria.
4. Presence of measurable disease at screening.
5. Received a PI and an IMiD (except thalidomide).
6. 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.
7. Expected survival ≥ 3 months.
8. Clinical laboratory values meet screening visit criteria
9. 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:

1. No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment).
2. Prior treatment with any antibody targeting BCMA.
3. Diagnosed or pretreated for an invasive malignancy other than multiple myeloma.
4. Prior anti-tumor treatment (before pretreatment) with insufficient washout period.
5. Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma.
6. 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.
7. Serious underlying medical conditions
8. Male subjects who have a birth plan during the study period or within 1 year after the study treatment.
9. Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment.
10. The investigator considered that the subjects were not suitable for any conditions of participation in the study.

Where it's running

• Beijing Gobroad Boren Hospital
  Beijing, Beijing, China Recruiting
• Zhejiang Provincial People's Hospital
  Hangzhou, Zhejiang, China Recruiting
• Shanghai Fourth People's Hospital Affiliated to Tongji University
  Shanghai, China Recruiting
• Institute of Hematology & Blood Diseases Hospital
  Tianjin, China Recruiting
• The First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, China Recruiting
• Shanghai Changzheng Hospital
  Shanghai, China Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CT0596 CAR-T in relapsed/refractory multiple myeloma: a phased dose-find and efficacy study

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• RO7851624 in relapsed/refractory multiple myeloma (RRMM)

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• KMA-targeted CAR T-cells for relapsed/refractory kappa-restricted multiple myeloma

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  Recruiting Phase 1 Peter MacCallum Cancer Centre, Australia · Melbourne, Victoria · NCT07541391

• IL-15–armored CAR-T for relapsed or refractory multiple myeloma and plasma cell leukemia

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• IMV102 treatment for relapsed or refractory multiple myeloma

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  Recruiting Early Phase 1 Suzhou Immunofoco Biotechnology Co., Ltd · Beijing and 3 other locations · NCT07493135

• See if SG2918 is safe for adults with relapsed/refractory multiple myeloma

  This study tests SG2918 in adults with relapsed or refractory multiple myeloma to see if it is safe and tolerable.

  Recruiting at 4 sites Phase 1/2 Hangzhou Sumgen Biotech Co., Ltd. · Zhengzhou, Henan and 3 other locations · NCT07454187

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.