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

NCT03672253 | Unknown Phase 1

• 1 other identifier: CAR-T re-treatment-MM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma; Multiple Myeloma in Relapse; Multiple Myeloma Progression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anti-myeloma responses

  Day 1-60 months

• Anti-myeloma responses

  Day 1-60 months

Study Arms (1)

CAR-T Re-treatment group

EXPERIMENTAL

Patients will be treated with CAR-T cells targeting BCMA (Different epitope with the previous CAR-T cell treatment they had been used) with a escalation approach, 0.5x10\^6- 2.0x10\^6 CAR-T cells/kg.

Drug: CAR-T Re-treatment

Interventions

CAR-T Re-treatment DRUG

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.

Also known as: CAR-T Re-treatment for r/r MM targeting BCMA

CAR-T Re-treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a confirmed prior diagnosis of active multiple myeloma as defined by the updated IMWG criteria.
• 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.
• Refractory disease：1) At least 3 prior regimens, which must at least have contained bortezomi. or 2) other circumstances identified by clinical doctors.
• Relapse criteria in NCCN clinical practice guidelines in Oncology: Multiple Myeloma (2016.V2).

You may not qualify if:

• Women of child-bearing potential or who are pregnant or breastfeeding.
• Have any active and uncontrolled infection: hepatitis B, hepatitis C, HIV, or other fatal viral and bacterial infection.
• 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.
• Patients with any uncontrolled intercurrent illness or serious uncontrolled medical disorder.
• Patients with CNS metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions and spinal cord compression).
• 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.
• Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis.
• other conditions that excluded by clinicians.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (1)

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Wan-Hong Zhao, MD, PhD

  Second Affiliated Hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: July 26, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 14, 2018

Record last verified: 2018-09

Locations

CN (1)