ClinicalTrials.gg
RecruitingNCT07248176Updated Dec 1, 2025

Universal CAR-T Cell Therapy for MM

An interventional study of Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection in Multiple Myeloma, Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, sponsored by Bioray Laboratories. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-01.

Sponsored by Bioray Laboratories · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2025, registered Nov 2025).
  • Started Apr 2025; still recruiting 1 year 7 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 448 studies in Multiple Myeloma with a site in China — 238 open to participants now, 275 under way, 47 of them phase 3. Multiple Myeloma · China.

Planned enrollment
390th of 406
6 · median 40
Started
2025
with 54 others
No phase
43 of 448
26 open now
Primary completion
2027-03
later than 133 of 274 live
Registered
381st of 448
by date

Among the 448 studies in Multiple Myeloma with a site in China, this one is the 390th largest by planned enrollment of the 406 interventional ones that give a count, is one of 55 that started in 2025, is one of 43 with no phase, reaches primary completion later than 133 of the 274 other live ones, and was the 381st registered.

Multiple Myeloma

3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

238 of the 448 studies in Multiple Myeloma with a site in China are open now. Recruiting first, the newest first:

233 more — sign in →

All 238 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 448 studies in Multiple Myeloma with a site in China, or all of them as a file.
02

Study summary

This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with r/r multiple myeloma.

Read the detailed description

This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for r/r multiple myeloma using universal CAR-T cells targeting BCMA .

03

Conditions studied

  • Multiple Myeloma
  • Multiple Myeloma in Relapse
  • Multiple Myeloma, Refractory

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Expected survival of at least 3 months;
  2. Subjects should have that meets the IMWG 2016 criteria;
  3. Previously received at least two lines of prior anti-myeloma therapy ;
  4. Relapse , failure to achieve at least a minimal response, or disease progression after the last treatment ;
  5. BCMA positive;
  6. score 0-1;
  7. No severe impairment or suppression of liver, kidney, coagulation, bone marrow, or lung function.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or breastfeeding women;
  2. History of other malignant tumors;
  3. Active diseases requiring immunotherapy;
  4. Previously received stem cell transplantation;
  5. Previous use of CAR-T cells or other genetically modified T cell therapies;
  6. Previously received targeted BCMA therapy;
  7. Severe cardiovascular disease;
  8. Active infection;
  9. Positive virology test;
  10. central nervous system (CNS) diseases or pathological changes.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

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

Study arms

  • Experimental
    Treatment group

    5.0-10×10\^6cells/kg

    Drug: Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection

Interventions

  • DrugTargeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection

    The study drug is administered intravenously at a fixed dose within 1-2 days after lymphocyte depletion, and its efficacy and safety are observed.

    Also known as: BRL-305

06

What researchers measure

Primary outcomes

  1. DLT

    The number and severity of dose-limiting toxicity (DLT) events

    Time frame: Within 28 Days After BRL-305 Infusion

  2. AEs

    The total number, incidence, and severity of AEs

    Time frame: Up to 24 Months After BRL-305 Infusion

07

Study locations

1 of 1 sites recruiting
  • Shanghi Tongji Hospital (Tongji Hospital of Tongji University)
    Shanghai, 620000, China
    Recruiting
    • Ping Li, phD · Contact13564181131
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Mar 2027, 23 months after the start.

Of 186 interventional studies with no phase under Multiple Myeloma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's planned 23 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2025
First posted
Nov 25, 2025
StartActual
Apr 10, 2025
Primary completionEst.
Mar 15, 2027
CompletionEst.
Apr 18, 2028
Last update
Dec 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07248176
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine
Responsible party
Sponsor
First posted
Nov 25, 2025
Start date
Apr 10, 2025
Primary completion
Mar 15, 2027 (estimated)
Completion
Apr 18, 2028 (estimated)
Last update
Dec 1, 2025

Study contacts

Ping Li, phD
Contact
lilyforever76@126.com
13564181131
Ping Li, PhD
study director · 13564181131

Oversight

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

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