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New treatment option for Multiple Myeloma
Official title a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease
ClinicalTrials.gov ID: NCT04776330
What this study is testing
What is BCMA targeted prime CAR-T cells?
BCMA targeted prime CAR-T cells is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Signed written informed consent;
- Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:
- Failed to standard chemotherapy regimens;
- Relapse after complete remission, high-risk and / or refractory patients ;
- Relapse after hematopoietic stem cell transplantation;
You likely can't join if
- Previous history of other malignancy;
- Presence of uncontrolled active infection;
- Evidence of disorder that need the treatment by glucocorticoids;
- Active or chronic GVHD
- The patients treatment by inhibitor of T cell
- Pregnant or breasting-feeding women;
See the full eligibility criteria
- Signed written informed consent;
- Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:
- Failed to standard chemotherapy regimens;
- Relapse after complete remission, high-risk and / or refractory patients ;
- Relapse after hematopoietic stem cell transplantation;
- Evidence for cell membrane BCMA expression
- All genders, ages: 18 to 75 years#
- The expect time of survive is above 3 months;
- KPS\>60
- No serious mental disorders ;
- Left ventricular ejection fraction ≥50%
- Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
- Sufficient renal function defined by creatinine clearance≤2 x ULN;
- 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...
- Previous history of other malignancy;
- Presence of uncontrolled active infection;
- Evidence of disorder that need the treatment by glucocorticoids;
- Active or chronic GVHD
- The patients treatment by inhibitor of T cell
- Pregnant or breasting-feeding women;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kunming, Yunnan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.