NCT03752541

Brief Summary

This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with relapsed or refractory multiple myeloma.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-myeloma

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

November 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

3.4 years

First QC Date

November 21, 2018

Last Update Submit

May 15, 2022

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed.

    Up to 90 days after T cell infusion

Secondary Outcomes (2)

  • Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability

    Up to 35 days after T cell infusion

  • Duration of persistence of BCMA-UCART

    Baseline up to 1 year

Study Arms (1)

BCMA-UCART

EXPERIMENTAL

Each subject will accept one of the following dosages of BCMA-UCART cells intravenously (IV) on day 0: 0.5-1\*10\~6/KgBW, 1-2\*10\~6/KgBW,2-3\*10\~6/KgBW.

Biological: BCMA-UCART

Interventions

BCMA-UCARTBIOLOGICAL

A conditioning therapy with cyclophosphamide and fludarabine will be conducted for subjects before CART therapy.

BCMA-UCART

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have the capacity to give informed consent;
  • Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria;
  • Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment);
  • Refractory and relapsed MM patients after \> 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT);
  • ECOG score=0-2.
  • Subjects according with any of the following options:
  • Age≥50;
  • Failure with separation of T cells during autologous CART processing; or,
  • Failure with expansion of autologous CART; or,
  • The proportion of T cells in PBMC \<10%; or,
  • Won't benefit from autologous CART therapy because of disease progress.

You may not qualify if:

  • Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
  • Active infection, HIV infection, syphilis serology reaction positive;
  • Active hepatitis B, hepatitis C at the time of screening
  • Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)\> 5 x upper limit of normal; bilirubin \> 3.0 mg/dL;
  • Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis
  • serious mental disorder;
  • With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
  • Participate in other clinical research in the past three months; previously treatment with any gene therapy products
  • Contraindication to cyclophosphamide or fludarabine chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, 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

  • Aibin Liang, PhD

    Shanghai Tongji Hospital, Tongji University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 0.5-1\*10\~6/KgBW, 1-2\*10\~6/KgBW,2-3\*10\~6/KgBW
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 26, 2018

Study Start

November 1, 2019

Primary Completion

March 20, 2023

Study Completion

November 20, 2023

Last Updated

May 20, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)