NCT04776330 a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease
| NCT ID | NCT04776330 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chongqing Precision Biotech Co., Ltd |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-03-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2021-03-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Sanbin Wang, MD
PRINCIPAL INVESTIGATOR
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Frequently Asked Questions
Who can join the NCT04776330 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04776330 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04776330 currently recruiting?
Yes, NCT04776330 is actively recruiting participants. Contact the research team at yangzhi@precision-biotech.com for enrollment information.
Where is the NCT04776330 trial being conducted?
This trial is being conducted at Kunming, China.
Who is sponsoring the NCT04776330 clinical trial?
NCT04776330 is sponsored by Chongqing Precision Biotech Co., Ltd. The principal investigator is Sanbin Wang, MD at 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China. The trial plans to enroll 80 participants.