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

NCT04541368 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: CS1-ZhejiangU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapse Multiple Myeloma

Keywords

multiple myeloma; CAR T-cell therapy; CS1

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Baseline up to 28 days after CS1 targeted CAR T-cells infusion

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

  Up to 2 years after CS1 targeted CAR T-cells infusion

Secondary Outcomes (6)

• Overall response rate (ORR)

  At Day 28

• Overall survival (OS)

  At Month 6, 12, 24

• Quality of life

  At Baseline, Month 1, 3, 6, 9 and 12

• Instrumental Activities of Daily Living (IADL) score

  At Baseline, Month 1, 3, 6, 9 and 12

• Activities of Daily Living (ADL) score

  At Baseline, Month 1, 3, 6, 9 and 12

Study Arms (1)

Administration of CS1 Targeted CAR T-cells

EXPERIMENTAL

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

Drug: CS1 Targeted CAR T-cells

Interventions

CS1 Targeted CAR T-cells DRUG

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

Also known as: CS1 Targeted CAR T-cells injection

Administration of CS1 Targeted CAR T-cells

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of CS1+ multiple myeloma (MM)：
• Patients with MM relapsed after BCMA CAR-T therapy;Or MM with positive CS1 expression and negative BCMA expression;
• Relapsed after hematopoietic stem cell transplantation;
• Cases with recurrent positive minimal residual disease;
• Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
• Anticipated survival time more than 12 weeks;
• Male or female aged 30-75 years;
• Those who voluntarily participated in this trial and provided informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital，College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

He Huang, PhD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

86-15957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: September 9, 2020
• Study Start: December 31, 2020
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)