CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04727008
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sichuan University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

Experimental: CXCR4 modified anti-BCMA CAR T cell therapy

CAR T cell therapy

Interventions

Biological: - CXCR4 modified anti-BCMA CAR T cells

intravenous infusion

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

DAN LI, Ph.D

lidan@wchscu.cn

+86(028)85423525

For additional contact information, you can also visit the trial on clinicaltrials.gov.