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Status unknownNCT05430945Updated Jun 24, 2022

A Study of BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

An Early Phase 1 interventional study of BCMA Targeted CAR T-cells in Relapse Multiple Myeloma and Refractory Multiple Myeloma, sponsored by Zhejiang University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2022-06-24.

Sponsored by Zhejiang University · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Sex
All
01

Study summary

Clinical Trial for the safety and efficacy of BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma

Read the detailed description

In this study, 100 patients with relapsed refractory multiple myeloma were proposed to undergo BCMA CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of BCMA CAR-T cell therapy for relapsed refractory multiple myeloma; At the same time, on the basis of expanding the sample size, more safety data on BCMA CAR-T cell treatment for relapsed refractory multiple myeloma were accumulated, including rare and delayed complications.

02

Conditions studied

  • Relapse Multiple Myeloma
  • Refractory Multiple Myeloma

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Keywords

  • multiple myeloma
  • CAR T-cell therapy
  • BCMA
03

In context

Multiple Myeloma

3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.

This study's planned enrollment of 100 is above the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.

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Lead sponsor

Zhejiang University is the lead sponsor of 355 studies on the registry; 166 are open to participants now.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
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. Histologically confirmed diagnosis of multiple myeloma (MM):

    1. Patients with BCMA positive relapsed/refractory MM;
    2. Relapsed after hematopoietic stem cell transplantation;
    3. Cases with recurrent positive minimal residual disease;
    4. Repeated MRD(+) refractory resistant cases

    5. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.

      2. Anticipated survival time more than 12 weeks; 3. Transplant patients, regardless of their previous treatment, are eligible after relapse; 4. Those who voluntarily participated in this trial and provided informed consent.

Exclusion criteria

Exclusion Criteria:

  • Subjects with any of the following exclusion criteria were not eligible for this trial:

    1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
    2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
    3. Pregnant (or lactating) women;
    4. With a graft-versus-host response, immunosuppressants are required;
    5. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
    6. Active infection of hepatitis B virus or hepatitis C virus;
    7. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
    8. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
    9. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
    10. Other uncontrolled diseases that were not suitable for this trial;
    11. Patients with HIV infection;
    12. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
05

Study design

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

Study arms

  • Experimental
    Administration of BCMA Targeted CAR T-cells

    Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

    Biological: BCMA Targeted CAR T-cells

Interventions

  • BiologicalBCMA Targeted CAR T-cells

    Each subject receive BCMA Targeted CAR T-cells by intravenous infusion

    Also known as: BCMA Targeted CAR T-cells injection

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

    Time frame: Baseline up to 28 days after BCMA targeted CAR T-cells infusion

  2. Incidence of treatment-emergent adverse events (TEAEs)

    Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

    Time frame: Up to 2 years after BCMA targeted CAR T-cells infusion

Secondary outcomes

  1. Overall response rate (ORR)

    Assessment of ORR at Day 28

    Time frame: At Day 28

  2. Overall survival (OS)

    Assessment of OS at Month 6, 12, 24

    Time frame: At Month 6, 12, 24

  3. Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)

    Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale \[For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome\] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12

    Time frame: At Baseline, Month 1, 3, 6, 9 and 12

  4. Instrumental Activities of Daily Living (IADL) score

    Assessment of Instrumental Activities of Daily Living (IADL) scale \[max score: 56, min score: 14, higher scores mean a worse outcome\] at Baseline, Month 1, 3, 6, 9 and 12

    Time frame: At Baseline, Month 1, 3, 6, 9 and 12

  5. Activities of Daily Living (ADL) score

    Assessment using Activities of Daily Living (ADL) scale (Barthel Index) \[max score: 100, min score: 0, higher scores mean a better outcome\] at Baseline, Month 1, 3, 6, 9 and 12

    Time frame: At Baseline, Month 1, 3, 6, 9 and 12

  6. Hospital Anxiety and Depression Scale (HADS) score

    Assessment of Hospital Anxiety and Depression Scale (HADS) score at Baseline, Month 1, 3, 6, 9 and 12

    Time frame: At Baseline, Month 1, 3, 6, 9 and 12

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital, Medical College, Zhejiang University
    Hangzhou, Zhejiang 310003, China
    Recruiting
08

References and documents

Publications

  • Chen R, Jin C, Liu K, Zhao M, Yang T, Zhang M, Xiao P, Feng J, Hong R, Fu S, Cui J, Huang S, Wei G, Huang H, Hu Y. Predictive value of pre-treatment circulating tumor DNA genomic landscape in patients with relapsed/refractory multiple myeloma undergoing anti-BCMA CAR-T therapy: Insights from tumor cells and T cells. Chin Med J (Engl). 2025 Oct 5;138(19):2481-2490. doi: 10.1097/CM9.0000000000003306. Epub 2024 Nov 6. PubMed 39501801 ↗
  • Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16. PubMed 37192741 ↗

Individual participant data

Plan to share: No

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

Start is estimated for Jun 2022; primary completion for Jun 2025, 36 months later.

Of 197 non-industry phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 99. This study's planned 36 months is below that.

Counting every sponsor, half of 402 studies reached it within 50 months; a quarter within 32 and three quarters within 76.

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

Registered
Jun 18, 2022
First posted
Jun 24, 2022
StartEst.
Jun 20, 2022
Primary completionEst.
Jun 20, 2025
CompletionEst.
Jun 20, 2025
Last update
Jun 24, 2022
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 Jun 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05430945
Lead sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
Responsible party
He Huang (Clinical Professor, Zhejiang University) — Principal investigator
First posted
Jun 24, 2022
Start date
Jun 20, 2022 (estimated)
Primary completion
Jun 20, 2025 (estimated)
Completion
Jun 20, 2025 (estimated)
Last update
Jun 24, 2022

Study contacts

He Huang, PhD
Contact
hehuangyu@126.com
86-13605714822
Yongxian Hu, PhD
Contact
huyongxian2000@aliyun.com
86-15957162012

Oversight

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

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