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

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03672253

Collaborator

Nanjing Legend Biotech Co. (Industry)

Enrollment

Location

Arm

29.2

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Multiple Myeloma in Relapse Multiple Myeloma Progression	Drug: CAR-T Re-treatment	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 26, 2018

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAR-T Re-treatment group 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 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. Other Names: CAR-T Re-treatment for r/r MM targeting BCMA

Arm

Intervention/Treatment

Experimental: CAR-T Re-treatment group

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

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.

Other Names:

CAR-T Re-treatment for r/r MM targeting BCMA

Outcome Measures

Primary Outcome Measures

Occurrence of treatment related adverse events [Day 1-30 days after injection]
assessed by CTCAE v4.0, >= Grade 1 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment

Secondary Outcome Measures

Anti-myeloma responses [Day 1-60 months]
by measuring the changes of aberrant immunoglobulin in serum
Anti-myeloma responses [Day 1-60 months]
multiple myeloma cells in bone marrow

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710000

Sponsors and Collaborators

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

Investigators

Principal Investigator: Wan-Hong Zhao, MD, PhD, Second Affiliated Hospital of Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital of Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT03672253

Other Study ID Numbers:

CAR-T re-treatment-MM

First Posted:

Sep 14, 2018

Last Update Posted:

Dec 14, 2018

Last Verified:

Sep 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Dec 14, 2018