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RecruitingNCT04727008Updated Dec 12, 2023

CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma

A Phase 1 interventional study of CXCR4 modified anti-BCMA CAR T cells in Multiple Myeloma, sponsored by Sichuan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by Sichuan University · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Sep 2022; still recruiting 4 years later.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 12 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    CXCR4 modified anti-BCMA CAR T cell therapy

    CAR T cell therapy

    Biological: CXCR4 modified anti-BCMA CAR T cells

Interventions

  • BiologicalCXCR4 modified anti-BCMA CAR T cells

    intravenous infusion

06

What researchers measure

Primary outcomes

  1. Dose limiting toxicities (DLT)

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

    Time frame: 2 years

  2. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 24 months

Secondary outcomes

  1. ORR (overall response rate)

    Proportion of subjects with the best overall response (BOR)

    Time frame: 3 months,6 months

  2. CRR (complete response rate)

    Proportion of subjects with the BOR of sCR+CR at Month 3

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • West China Hospital, Sichuan University
    Chengdu, Sichuan 610041, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04727008
Lead sponsor
Sichuan University
Responsible party
Ting Niu (Director of Department of Hematology, West China Hospital) — Principal investigator
First posted
Jan 27, 2021
Start date
Sep 21, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 12, 2023

Study contacts

DAN LI, Ph.D
Contact
lidan@wchscu.cn
+86(028)85423525
FUCHUN GUO, MD
Contact
FCguo0797@wchscu.cn
+86(028)85423525

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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