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Can engineered immune cells outsmart Treatment-Resistant myeloma?

NCT ID NCT05376345

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental therapy called LCAR-BCDR, which uses a patient's own immune cells that have been engineered to recognize and attack a protein called BCMA found on myeloma cells. The study aims to see if this treatment is safe and tolerable, and whether it can shrink tumors in people with multiple myeloma that has returned or stopped responding to standard treatments. Participants will receive a conditioning regimen before the cell infusion, and researchers will monitor side effects and how long the cells persist in the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LCAR-BCDR cells, a type of CAR-T cell therapy targeting BCMA
What this could lead to
If successful, this could lead to a new treatment option that may achieve long-lasting remission for patients with multiple myeloma who have not responded to standard therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so safety and effectiveness are not yet established. CAR-T therapy can cause severe side effects, and the treatment may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Sep 2022

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease; 2. Subjects ≥ 18 years of age. 3. Documented initial diagnosis of MM according to IMWG diagnostic criteria. 4. Presence of measurable disease at screening. 5. Received a PI and an IMiD (except thalidomide). 6. Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible. 7. Expected survival ≥ 3 months. 8. Clinical laboratory values meet screening visit criteria 9. Fertile women must be negative using a highly sensitive serum pregnancy test (β human chorionic gonadotropin \[β -HCG\]) at screening time and before initial treatment with cyclophosphamide and fludarabine; Exclusion Criteria: 1. No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment). 2. Prior treatment with any antibody targeting BCMA. 3. Diagnosed or pretreated for an invasive malignancy other than multiple myeloma. 4. Prior anti-tumor treatment (before pretreatment) with insufficient washout period. 5. Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma. 6. Positive of any hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), human immunodeficiency virus antibody (HIV-Ab) at the time of screening. 7. Serious underlying medical conditions 8. Male subjects who have a birth plan during the study period or within 1 year after the study treatment. 9. Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment. 10. The investigator considered that the subjects were not suitable for any conditions of participation in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beijing Boren Hospital

    Beijing, Beijing Municipality, China

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, China

  • Shanghai Changzheng Hospital

    Shanghai, China

  • Shanghai Fourth People's Hospital Affiliated to Tongji University

    Shanghai, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China

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