NCT04776330

Brief Summary

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline
14mo left

Started Mar 2021

Longer than P75 for phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress82%
Mar 2021Jul 2027

First Submitted

Initial submission to the registry

February 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 7, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

5.8 years

First QC Date

February 26, 2021

Last Update Submit

February 23, 2025

Conditions

Multiple MyelomaNeoplasm, Plasma CellMultiple Myeloma in Relapse

Keywords

Multiple MyelomaBCMAprime Chimeric Antigen Receptor T Cell

Outcome Measures

Primary Outcomes (2)

  • Adverse events that related to treatment

    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

    2 years

  • The response rate of BCMA targeted prime CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA targeted prime CAR-T cells therapy

    The response rate of BCMA targeted prime CAR-T treatment will be recorded and assessed according to the IMWG

    2 years

Secondary Outcomes (7)

  • Rate of BCMA targeted prime CAR-T cells in bone marrow and peripheral blood

    2 years

  • Quantity of BCMA targeted prime CAR copies in bone marrow and peripheral blood

    2 years

  • Quantity of clonal plasma cells in bone marrow

    1 years

  • Levels of IL-6 in Serum

    1years

  • Duration of Response (DOR) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma

    2 years

  • +2 more secondary outcomes

Study Arms (1)

BCMA targeted prime CAR-T cells treat

EXPERIMENTAL

Patients will be be treated with BCMA targeted prime CAR-T cells

Biological: BCMA targeted prime CAR-T cells

Interventions

BCMA targeted prime CAR-T cellsBIOLOGICAL

BCMA targeted prime CAR-T cell therapy

BCMA targeted prime CAR-T cells treat

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent;
  • Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:
  • Failed to standard chemotherapy regimens;
  • Relapse after complete remission, high-risk and / or refractory patients ;
  • Relapse after hematopoietic stem cell transplantation;
  • Evidence for cell membrane BCMA expression
  • All genders, ages: 18 to 75 years#
  • The expect time of survive is above 3 months;
  • KPS\>60
  • No serious mental disorders ;
  • Left ventricular ejection fraction ≥50%
  • Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
  • Sufficient renal function defined by creatinine clearance≤2 x ULN;
  • Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications;
  • \. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

You may not qualify if:

  • Previous history of other malignancy;
  • Presence of uncontrolled active infection;
  • Evidence of disorder that need the treatment by glucocorticoids;
  • Active or chronic GVHD
  • The patients treatment by inhibitor of T cell
  • Pregnant or breasting-feeding women;
  • Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

920th Hospital of Joint Logistics Support Force

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Sanbin Wang, MD

    920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    PRINCIPAL INVESTIGATOR

  • Cheng Qian, PhD

    Chongqing University Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Yang, PhD

CONTACT

86-13206140093yangzhi@precision-biotech.com

Study Design

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

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 1, 2021

Study Start

March 7, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations

CN(1)