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Human BCMA Targeted T Cells Injection（BCMA CAR-T）for Subjects With R/R MM

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHrain Biotechnology Co., Ltd.

About this trial

A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection（BCMA CAR-T） Therapy for R/R MM.

Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures;

18 to 75 years old (including cut-off value)，gender is not limited;

Expected survival > 12 weeks;

Previously diagnosed as multiple myeloma by the International Myeloma Working Group（IMWG） updated criteria;

Disqualifiers

Subjects have a history of central nervous system (CNS) diseases such as seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychosis; known or history of active central nervous system (CNS) involvement or presentation of multiple myeloma meninge/meningeal involvement;

Subjects with plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis;

Accompanied by other uncontrolled malignancies, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection ;

Any uncontrollable active infection, including but not limited to active tuberculosis; fungal, bacterial, viral, or other infections that are uncontrollable or require systemic intravenous therapy are present or suspected within 14 days prior to enrollment;

Trial design

Design model

Single group

Treatments tested in this trial

  • Human BCMA Targeted T Cells Injection

    Drug

    A single dose of predetermined level CAR-positive T cells will be infused.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Human BCMA Targeted T Cells InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) at 3 months post infusion as evaluated by the Independent Review Committee

ORR at 3 months post infusion as evaluated by the Independent Review Committee (IRC) includes stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR).

Time frame
3 months post infusion

Secondary outcomes

1

Duration of remission (DOR) after administration

DOR refers to the time from the first assessment of the tumor for complete response and above efficacy to the first assessment of disease progression or death of any cause;

Time frame
2~3 years post infusion
2

Progression-free Survival (PFS) after administration

PFS refers to the time from the start of cell infusion to the first assessment of tumor progression or death from any cause;

Time frame
2~3 years post infusion
3

Overall Survival (OS) after administration

OS refers to the time from cell infusion to death due to any cause;

Time frame
2~3 years post infusion
4

Objective Response Rate (ORR) at 3 months post infusion as evaluated by the Investigator

ORR at 3 months post infusion as evaluated by the Investigator;

Time frame
3 months post infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hrain Biotechnology Co., Ltd.

Lead sponsor

Shanghai Changzheng Hospital

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Source ClinicalTrials.gov
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