CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma

NCT04727008 | Unknown Phase 1

• 1 other identifier: MCART-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicities (DLT)

  Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration

  2 years

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  24 months

Secondary Outcomes (2)

• ORR (overall response rate)

  3 months，6 months

• CRR (complete response rate)

  3 months

Study Arms (1)

CXCR4 modified anti-BCMA CAR T cell therapy

EXPERIMENTAL

CAR T cell therapy

Biological: CXCR4 modified anti-BCMA CAR T cells

Interventions

CXCR4 modified anti-BCMA CAR T cells BIOLOGICAL

intravenous infusion

CXCR4 modified anti-BCMA CAR T cell therapy

Eligibility Criteria

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

You may qualify if:

• Male or female, 18 to 75 years old.
• The expected survival ≥ 12 week
• ECOG ≤ 2
• Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse
• The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease
• Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection
• Patients can take effective contraceptive measures during the trial period and 1 year after the infusion
• Voluntary informed consent is given, agree to follow the trial treatment and visit plan

You may not qualify if:

• Patients with other uncontrollable cancer
• Active hepatitis B, hepatitis C, or HIV infection
• Other uncontrolled active disease
• Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases
• Patients with uncontrollable hypertension(≥ grade II)
• Patients with history of uncontrollable mental illness
• Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded)
• Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment;
• 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;
• Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment;
• Patients had other conditions that were not appropriate for the study determined by the researchers.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

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

DAN LI, Ph.D

CONTACT

+86(028)85423525; lidan@wchscu.cn

FUCHUN GUO, MD

CONTACT

+86(028)85423525; FCguo0797@wchscu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Hematology

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: January 27, 2021
• Study Start: September 21, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)