CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma

NCT ID: NCT04727008

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2025-12-31

Brief Summary

Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. The efficacy of CXCR4 modified BCMA CAR T will also be investigated.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CXCR4 modified anti-BCMA CAR T cell therapy

CAR T cell therapy

Group Type: EXPERIMENTAL

CXCR4 modified anti-BCMA CAR T cells

Intervention Type: BIOLOGICAL

intravenous infusion

Interventions

CXCR4 modified anti-BCMA CAR T cells

intravenous infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female, 18 to 75 years old.

2. The expected survival ≥ 12 week

3. ECOG ≤ 2

4. Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse

5. The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease

6. Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection

7. Patients can take effective contraceptive measures during the trial period and 1 year after the infusion

8. Voluntary informed consent is given, agree to follow the trial treatment and visit plan

Exclusion Criteria

1. Patients with other uncontrollable cancer

2. Active hepatitis B, hepatitis C, or HIV infection

3. Other uncontrolled active disease

4. Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases

5. Patients with uncontrollable hypertension(≥ grade II)

6. Patients with history of uncontrollable mental illness

7. Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded)

8. Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment;

9. Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period;

10. Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment;

11. Patients had other conditions that were not appropriate for the study determined by the researchers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Ting Niu

Director of Department of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

DAN LI, Ph.D

Role: CONTACT

Phone: +86(028)85423525

Email: lidan@wchscu.cn

FUCHUN GUO, MD

Role: CONTACT

Phone: +86(028)85423525

Email: FCguo0797@wchscu.cn

Facility Contacts

Dan Li

Role: primary

Other Identifiers

MCART-001

Identifier Type: -

Identifier Source: org_study_id