Clinical Trials in China / NCT04271644
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 920th Hospital of Joint Logistics Support Force | Kunming | Yunnan | Recruiting |
More Chongqing Precision Biotech Co., Ltd trials in China
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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