Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 75

BCMA-targeted CAR-T cell therapy for relapsed multiple myeloma

Official title: Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

Run by Chongqing Precision Biotech Co., Ltd · NCT04776330 · Data updated 2026-11-12

This study is testing a new CAR-T cell therapy that targets a specific protein in people with relapsed multiple myeloma to see if it can help them when other treatments haven't worked.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment80 (estimated)
SponsorChongqing Precision Biotech Co., Ltd
Industry-sponsored
Drugs / interventionschemotherapy, CAR-T
Locations1 site (Kunming, Yunnan)
StatusRecruiting
StartedMarch 7, 2021
Main results expectedDecember 31, 2026
Study endsJuly 1, 2027
Registry record updatedFebruary 25, 2025
Trial IDNCT04776330 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 to 75 with relapsed or refractory multiple myeloma who have failed standard treatments.

Probably not a fit

Patients with serious mental disorders or those with significant comorbidities affecting their organ function may not benefit from this study.

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 efficacy of BCMA-targeted prime CAR-T cell therapy in patients with relapsed or refractory multiple myeloma. The study is a single-arm intervention where participants receive CAR-T cells designed to target BCMA, a protein commonly found on multiple myeloma cells. The primary focus is to assess adverse events and the disease status of patients following treatment. This approach aims to provide a new treatment option for patients who have limited alternatives due to the nature of their disease.

Why it matters

Potential benefit: If successful, this therapy could offer a new, effective treatment option for patients with relapsed or refractory multiple myeloma.

How similar studies have gone: Other studies targeting BCMA with CAR-T cell therapy have shown promising results, indicating a potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Signed written informed consent;
2. Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. Evidence for cell membrane BCMA expression
4. All genders, ages: 18 to 75 years#
5. The expect time of survive is above 3 months;
6. KPS\>60
7. No serious mental disorders ;
8. Left ventricular ejection fraction ≥50%
9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications;

13\. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD
5. The patients treatment by inhibitor of T cell
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Where it's running

  • 920th Hospital of Joint Logistics Support Force
    Kunming, Yunnan, China
    Recruiting

Study contacts

  • Principal investigator: Sanbin Wang, MD — 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
  • Study coordinator: Zhi Yang, PhD
  • Email: yangzhi@precision-biotech.com
  • Phone: 86-13206140093

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.