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Relapsed/Refractory Multiple MyelomaPhase 1NCT05498545

Universal BCMA-targeted LUCAR-B68 Cells in Patients With Relapsed/Refractory Multiple Myeloma

A Phase 1 study testing LUCAR-B68 cells product in people with Relapsed/Refractory Multiple Myeloma, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Universal BCMA-targeted LUCAR-B68 Cells Product in Patients With Relapsed/Refractory Multiple Myeloma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
LUCAR-B68 cells product
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChina
Study dates
24 Nov 2022to 30 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • Subjects ≥ 18 years of age.
  • Eastern Cooperative Oncology Group performance status score of 0, 1, or 2;
  • Documented initial diagnosis of MM according to IMWG diagnostic criteria.
  • Presence of measurable disease at screening.
  • Received a PI and an IMiD (except thalidomide).
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  • 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.
  • Expected survival ≥ 3 months.
  • Clinical laboratory values meet screening visit criteria
  • 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;

Who cannot join

  • No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment);
  • Prior treatment with any antibody targeting BCMA;
  • Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma;
  • Serious underlying medical conditions
  • 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;
  • Male subjects who have a birth plan during the study period or within 1 year after the study treatment
  • Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment
  • The investigator considered that the subjects were not suitable for any conditions of participation in the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710000

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Universal BCMA-targeted LUCAR-B68 Cells Product in Patients With Relapsed/Refractory Multiple Myeloma

A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Universal BCMA-targeted LUCAR-B68 Cells Product in Patients With Relapsed/Refractory Multiple Myeloma

Read the detailed description

This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LUCAR-B68 cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy

Being tested
LUCAR-B68 cells product
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LUCAR-B68 cells productBiological

    Before treatment with LUCAR-B68 cells, subjects will receive a conditioning regimen

Study groups in NCT05498545
Study groupRoleWhat they receive
LUCAR-B68 cells productExperimentalEach subject will receive LUCAR-B68 cells
Receives: Biological: LUCAR-B68 cells product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

    An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment

    Measured: Minimum 2 years after LUCAR-B68 infusion (Day 1

  2. Dose-limiting toxicity (DLT) rate

    Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose

    Measured: Minimum 2 years after LUCAR-B68 infusion (Day 1)

  3. Recommended Phase 2 dose (RP2D) finding

    RP2D established through ATD+BOIN design

    Measured: 30 days after LUCAR-B68 infusion (Day 1)

  4. CAR positive NK cells in peripheral blood and bone marrow

    CAR positive NK cells in peripheral blood and bone marrow after LUCAR-B68 infusion

    Measured: Minimum 2 years after LUCAR-B68 infusion (Day 1)

  5. CAR transgene levels in peripheral blood

    CAR transgene levels in peripheral blood after LUCAR-B68 infusion

    Measured: Minimum 2 years after LUCAR-B68 infusion (Day 1)

Secondary outcomes (6)

  1. Overall response rate (ORR)

    The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria

    Measured: Minimum 2 years after LUCAR-B68 infusion (Day 1)

  2. Duration of Response (DOR)

    Duration of response (DOR) will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria or death due to any cause, whichever occurs first

    Measured: Minimum 2 years after LUCAR-B68 infusion (Day 1)

  3. Time to Response (TTR)

    Time to response (TTR) is defined as the time between date of the initial infusion of LCAR-B38M CAR-T cells and the first efficacy evaluation that the participant has met all criteria for PR or better

    Measured: Minimum 2 years after LUCAR-B68 infusion (Day 1)

  4. Progress Free Survival (PFS)

    Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LUCAR-B68 to the first documented disease progression (according to IMWG criteria) or death (due to any cause), whichever occurs first

    Measured: 2 years after LUCAR-B68 infusion (Day 1)

  5. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from the date of first infusion of LUCAR-B68 to death of the subject

    Measured: Minimum 2 years after LUCAR-B68 infusion (Day 1)

  6. Incidence of anti- LUCAR-B68 antibody

    Venous blood samples will be collected to measure LUCAR-B68 positive cell concentrations and the transgenic level of LUCAR-B68, at the time points when anti- LUCAR-B68 antibody serum samples are evaluated

    Measured: Minimum 2 years after LUCAR-B68 infusion (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2022
  2. Study start24 Nov 2022
  3. Primary completion30 May 2025
  4. Study completion30 May 2025

Why it stopped: Achieved the proof of concept

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05498545
Sponsor's protocol ID
BM2L202201
Status last verified
Jun 2026
First submitted
10 Aug 2022
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LUCAR-B68 cells product in people with Relapsed/Refractory Multiple Myeloma, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Achieved the proof of concept). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, severity, and type of treatment-emergent adverse events (TEAEs) (time frame: Minimum 2 years after LUCAR-B68 infusion (Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05498545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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