CAR-T Re-treatment for Refractory/Relapsed Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Study of CAR-T Cells Targeting BCMA for Previously CAR-T Treated Refractory/Relapsed Multiple Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03672253
• Other study ID #: CAR-T re-treatment-MM
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 26, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2018
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single arm, open-label, single-center, phase 1 study, to determine the safety and efficacy of autologous reinfusion of CAR-T cells targeting BCMA in the treatment of refractory/relapsed multiple myeloma (r/r MM) who get recurrence and progression after previous CAR-T cell therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria.

2. Patients with refractory multiple myeloma. Clear BCMA expression must be detected on malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry.

3. Refractory disease:1) At least 3 prior regimens, which must at least have contained bortezomi. or 2) other circumstances identified by clinical doctors.

4. Relapse criteria in NCCN clinical practice guidelines in Oncology: Multiple Myeloma (2016.V2).

Exclusion Criteria:

1. Women of child-bearing potential or who are pregnant or breastfeeding.

2. Have any active and uncontrolled infection: hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection.

3. Systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen.

4. Patients with any uncontrolled intercurrent illness or serious uncontrolled medical disorder.

5. Patients with CNS metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions and spinal cord compression).

6. History of allogeneic stem cell transplantation. Have active acute or chronic graft-versus-host-disease (GVHD), or require immunosuppressant medications for GVHD, within 6 months of enrollment.

7. Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis.

8. other conditions that excluded by clinicians.

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Multiple Myeloma Progression
• Neoplasms, Plasma Cell

Intervention

Drug:
• CAR-T Re-treatment
Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) or use their mononuclear cells that preserved in the laboratory for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the re-treatment of CAR-T therapy by intravenous injection.

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University	Nanjing Legend Biotech Co.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of treatment related adverse events	assessed by CTCAE v4.0, >= Grade 1 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment	Day 1-30 days after injection
Secondary	Anti-myeloma responses	by measuring the changes of aberrant immunoglobulin in serum	Day 1-60 months
Secondary	Anti-myeloma responses	multiple myeloma cells in bone marrow	Day 1-60 months