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A Study of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy

NCT ID: NCT04541368

Last Updated: 2020-12-10

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

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2026-12-31

Brief Summary

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Clinical trial for the safety and efficacy of CS1-targeted CAR-T Cells therapy for relapsed multiple myeloma after BCMA CAR-T cells therapy

Detailed Description

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This is a single arm, open-label, single-center study. This study is indicated for relapsed CS1+ multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 50 patients will be enrolled for this trial. Primary objective is to explore the safety, main consideration is dose-related safety.

Conditions

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Relapse Multiple Myeloma

Keywords

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multiple myeloma CAR T-cell therapy CS1

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 CS1 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

CS1 Targeted CAR T-cells

Intervention Type DRUG

Each subject receive CS1 Targeted CAR T-cells by intravenous infusion

Interventions

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CS1 Targeted CAR T-cells

Each subject receive CS1 Targeted CAR T-cells by intravenous infusion

Intervention Type DRUG

Other Intervention Names

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CS1 Targeted CAR T-cells injection

Eligibility Criteria

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Inclusion Criteria

1. Histologically confirmed diagnosis of CS1+ multiple myeloma (MM)：

1. Patients with MM relapsed after BCMA CAR-T therapy;Or MM with positive CS1 expression and negative BCMA expression;
2. Relapsed after hematopoietic stem cell transplantation;
3. Cases with recurrent positive minimal residual disease;
4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
2. Anticipated survival time more than 12 weeks;
3. Male or female aged 30-75 years;
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 hemorrhagicdiseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infectionand bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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He Huang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital，College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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He Huang, PhD

Role: CONTACT

Phone: 86-13605714822

Email: [email protected]

Yongxian Hu, PhD

Role: CONTACT

Phone: 86-15957162012

Email: [email protected]

Facility Contacts

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He Huang, PhD

Role: primary

Other Identifiers

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CS1-ZhejiangU

Identifier Type: -

Identifier Source: org_study_id