Ireland
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Recruiting Phase 1/2

BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

NCT04271644 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2019-04-01
Last updated
2025-02-25

Condition(s) studied

Multiple MyelomaNeoplasm, Plasma CellMultiple Myeloma in Relapse

Investigational drug(s) / intervention(s)

BCMA CAR-T cells

BCMA CAR-T cells: BCMA CAR-T cell therapy

Study summary

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Adverse events that related to treatment — 2 years
    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
  • The response rate of BCMA CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA CAR-T cells therapy — 2 years
    The response rate of BCMA CAR-T treatment will be recorded and assessed according to the IMWG

Trial sites (1)

FacilityCityRegionStatus
920th Hospital of Joint Logistics Support Force Kunming Yunnan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04271644 on ClinicalTrials.gov ↗ ← All trials in China