A Study of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2025-06-20

Brief Summary

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Clinical Trial for the safety and efficacy of BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma

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Detailed Description

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In this study, 100 patients with relapsed refractory multiple myeloma were proposed to undergo BCMA CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of BCMA CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on BCMA CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.

Conditions

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Relapse Multiple Myeloma Refractory Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Administration of BCMA Targeted CAR T-cells

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Group Type EXPERIMENTAL

BCMA Targeted CAR T-cells

Intervention Type BIOLOGICAL

Each subject receive BCMA Targeted CAR T-cells by intravenous infusion

Interventions

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BCMA Targeted CAR T-cells

Each subject receive BCMA Targeted CAR T-cells by intravenous infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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BCMA Targeted CAR T-cells injection

Eligibility Criteria

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Inclusion Criteria

* 1\. Histologically confirmed diagnosis of multiple myeloma (MM):

1. Patients with BCMA positive relapsed/refractory MM;
2. Relapsed after hematopoietic stem cell transplantation;
3. Cases with recurrent positive minimal residual disease;
4. Repeated MRD(+) refractory resistant cases
5. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.

2\. Anticipated survival time more than 12 weeks; 3. Transplant patients, regardless of their previous treatment, are eligible after relapse; 4. Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. With a graft-versus-host response, immunosuppressants are required;
5. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
6. Active infection of hepatitis B virus or hepatitis C virus;
7. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
8. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
9. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
10. Other uncontrolled diseases that were not suitable for this trial;
11. Patients with HIV infection;
12. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Eligible Sex

ALL

Accepts Healthy Volunteers

No