Using modified CAR T cells to treat multiple myeloma

Phase I Study of A CXCR4 Modified BCMA CAR-T in Patients With Refractory and/or Relapsed Multiple Myeloma

This study is testing a new type of CAR T cell treatment for people with multiple myeloma who haven't had success with regular therapies to see if it can help them.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Drugs / interventions: CAR T
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT04727008 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of CXCR4 modified anti-BCMA CAR T cells in patients with multiple myeloma who have not responded to standard treatments. It involves a dose-escalation approach to determine the best dosage while monitoring for safety and tolerance. The trial aims to provide a new treatment option for patients with refractory or relapsed multiple myeloma, a condition that is often difficult to treat. Participants will be closely monitored throughout the treatment process.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with multiple myeloma who have not achieved a minor response or have relapsed after at least one line of standard therapy.

Not a fit: Patients with other uncontrolled cancers or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new hope for patients with refractory multiple myeloma who have limited options.

How similar studies have performed: Other studies using CAR T cell therapies have shown promising results in treating various hematological malignancies, suggesting potential success for this approach.

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: DAN LI, Ph.D

Conditions Multiple Myeloma