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Recruiting NCT04776330

a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

Phase I / Phase II Interventional Multiple Myeloma Neoplasm, Plasma Cell Multiple Myeloma in Relapse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BCMA targeted prime CAR-T cells.
Who it may be relevant to
Registry conditions: Multiple Myeloma, Neoplasm, Plasma Cell, Multiple Myeloma in Relapse. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

Overview

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.

Detailed description

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of prime CAR- T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Interventions

  • Biological BCMA targeted prime CAR-T cells
    BCMA targeted prime CAR-T cell therapy

Primary outcome measures

  • Adverse events that related to treatment [Time frame: 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 [Time frame: 2 years]
Secondary outcome measures (7)
  • Rate of BCMA targeted prime CAR-T cells in bone marrow and peripheral blood [Time frame: 2 years]
  • Quantity of BCMA targeted prime CAR copies in bone marrow and peripheral blood [Time frame: 2 years]
  • Quantity of clonal plasma cells in bone marrow [Time frame: 1 years]
  • Levels of IL-6 in Serum [Time frame: 1years]
  • Duration of Response (DOR) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma [Time frame: 2 years]
  • Progress-free survival(PFS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma [Time frame: 2 years]
  • Overall survival(OS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • 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;

13\. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • 920th Hospital of Joint Logistics Support Force — Kunming

Identifiers

NCT: NCT04776330 · PBC027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗