NCT03674463

Brief Summary

This is a single arm, open-label, phase 1 study, to determine the safety and efficacy of LCAR-B4822M CAR-T cells in treating patients diagnosed with refractory/relapsed multiple myeloma (r/r MM).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 14, 2018

Status Verified

September 1, 2018

Enrollment Period

2.4 years

First QC Date

September 12, 2018

Last Update Submit

December 13, 2018

Conditions

Refractory or Relapsed Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Occurrence of treatment related adverse events

    Assessed by CTCAE v4.0

    Day 1-30 days after injection

Secondary Outcomes (2)

  • Anti-myeloma responses to LCAR-B4822M cell treatment

    Day 1-36 months after injection

  • Anti-myeloma responses to LCAR-B38M cell treatment

    Day 1-36 months after injection

Study Arms (1)

LCAR-B4822M treatment group

EXPERIMENTAL

r/r multiple myeloma patients will be treated with LCAR-B4822M CAR-T cells with a escalation approach, 0.5x10\^6- 2.0x10\^6 CAR-T cells/kg.

Drug: LCAR-B4822M CAR-T Cell Immunotherapy

Interventions

LCAR-B4822M CAR-T Cell ImmunotherapyDRUG

Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the LCAR-B4822M CAR-T Cell Immunotherapy by intravenous injection.

LCAR-B4822M treatment group

Eligibility Criteria

Age18 Years - 73 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune 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 12, 2018

First Posted

September 17, 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)