Phase 2 Myeloma Trial, Recruiting NCT05998928 Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Condition: Myeloma
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Phase 2 Myeloma Trial, Recruiting

NCT05998928
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The patient, or their legal guardian, is willing to participate and sign a consent form
  • Age is between 18 and 75 years old
  • A confirmed diagnosis of Multiple Myeloma (a type of blood cancer) according to international diagnostic standards
  • Certain measurable signs of the disease are present in blood or urine tests at the time of screening (confirm with trial site for specific test thresholds)
  • The myeloma has come back or stopped responding to treatment after at least three prior treatment courses, which must have included at least one of each of three specific drug types: a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody treatment (confirm with trial site for specific drug names)
  • The disease is classified as relapsed (came back) or refractory (stopped responding to treatment), including cases that never responded to treatment at all
  • The most recent treatment either did not work, or the disease got worse within 60 days of finishing it
  • Side effects from the last treatment have mostly resolved to a mild level before joining
  • The person is reasonably functional day-to-day (able to care for themselves but may not be able to do heavy physical work) and expected to live at least 3 months
  • Liver function test results are within acceptable ranges
  • Kidney function test results are within acceptable ranges
  • Blood count (haemoglobin) is at an acceptable level without a recent blood transfusion in the past 7 days
  • Blood oxygen levels are adequate (above 92%)
  • Calcium levels in the blood are within an acceptable range
  • Heart pumping function is adequate (above 45%), with no significant fluid around the heart and no clinically important abnormal heart readings
  • No significant fluid build-up around the lungs
  • Suitable veins are available for blood collection procedures

Who may not be able to join:

  • A diagnosis of another cancer that was treated within the past 3 years
  • Having received certain anti-cancer treatments (such as targeted therapies, chemotherapy, monoclonal antibodies, radiation, or certain clinical trial treatments) before the blood collection (apheresis) procedure
  • The myeloma has spread to the central nervous system (brain or spinal cord)
  • A diagnosis of certain related blood or protein disorders, including Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis
  • Active or detectable infection with hepatitis B, hepatitis C, HIV, cytomegalovirus (CMV), or Epstein-Barr virus (EBV) based on blood tests
  • A history of severe allergic reactions
  • Serious ongoing illness, or significantly poor heart, liver, or kidney function
  • Graft-versus-host disease (a complication sometimes seen after transplants) occurring within the past 6 months, or currently requiring immune-suppressing medications for it
  • Active autoimmune or inflammatory conditions affecting the nervous system
  • A cancer-related emergency that needs treatment before joining the trial
  • An active infection currently requiring antibiotic treatment
  • Use of growth factor medications (used to stimulate blood cell production) within 1–2 weeks before the blood collection procedure
  • Use of corticosteroids (such as prednisone) or immune-suppressing medications within 2 weeks before the blood collection procedure
  • A major surgical operation within 4 weeks before the lymphodepletion stage of treatment, not yet fully recovered from surgery, or a major operation planned during the study
  • Receipt of a live attenuated vaccine (a type of vaccine using a weakened live virus) within 4 weeks before screening
  • A serious mental illness
  • Dependence on alcohol or drugs
  • Currently pregnant or breastfeeding; or the patient or their partner plans to have a child within two years after receiving the CAR-T cell treatment
  • Any other condition the trial doctor considers makes participation unsuitable

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Heng Mei, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Phone: 027-8572600

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Registry
ClinicalTrials.gov
Start date
27 July 2023
Est. completion
27 July 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence of Treatment-related Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov