BCMA-targeted CAR-T cell therapy for multiple myeloma

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

This study is testing a new CAR-T cell therapy that targets a specific protein in multiple myeloma to see if it can help patients whose cancer has come back or hasn't responded to other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chongqing Precision Biotech Co., Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, CAR-T
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT04271644 on ClinicalTrials.gov

What this trial studies

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

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with relapsed or refractory multiple myeloma who have failed standard treatments.

Not a fit: Patients with serious mental disorders or those with significant comorbidities affecting organ function may not benefit from this study.

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 performed: Other studies have shown promising results with CAR-T therapies targeting BCMA, indicating potential for success in this approach.

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.

Where this trial is running

Kunming, Yunnan

• 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

Conditions Multiple Myeloma; Neoplasm, Plasma Cell; Multiple Myeloma in Relapse; BCMA; Chimeric Antigen Receptor T Cell