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Systemic Lupus ErythematosusPhase 1NCT06978738

UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases

A Phase 1 study testing universal allogeneic anti-CD19/BCMA CAR T-cells in people with Systemic Lupus Erythematosus and Autoimmune Hemolytic Anemia, run by Changzhou No.2 People's Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
universal allogeneic anti-CD19/BCMA CAR T-cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
May 2025to Nov 2028
Phase
Phase 1

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

  • 1.Age ≥ 18 years old (inclusive), regardless of gender.
  • 2.Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
  • 3.Functional requirements for major organs are as follows:
  • Bone marrow function must meet: A. Neutrophil count ≥ 0.5×10 ^ 9/L (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g/L; C. Platelets ≥ 30 × 10 ^ 9/L.
  • Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤1.5×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome);
  • Renal function: creatinine clearance rate (CrCl) ≥ 30ml/minute (calculated by Cockcroft/Gault formula, acute CrCl decrease due to the target disease is excluded; LN is exluded);
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  • 4.ECOG score 0-1.
  • 5.Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.
  • 6.Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
  • 7.Subjects with relapsed or refractory autoimmune diseases, Including relapsed or refractory Autoimmune Hemolytic Anemia, relapsed or refractory Systemic Lupus Erythematosus, relapsed or refractory or Progressive Systemic Sclerosis, relapsed or refractory or Progressive Inflammatory Myopathy, relapsed or refractory ANCA-Associated Vasculitis, relapsed or refractory Immunoglobulin-G4 related disease and relapsed or refractory Myasthenia Gravis.

Who cannot join

  • 1.Subjects with a history of severe drug allergies or allergic constitutions;
  • 2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;
  • 3. Subjects with insufficient cardiac function;
  • 4. Subjects with congenital immunoglobulin deficiencies;
  • 5. Subjects with a history of malignant tumors within the past five years, except for the following conditions: non-melanoma skin cancer, stage I tumors with a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown by smear, and stable papillary thyroid carcinoma or follicular thyroid carcinoma.
  • 6. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA >ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing;
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  • 7. Subjects with mental illness and severe cognitive dysfunction;
  • 8. Pregnant women or women planning to conceive;
  • 9.Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xuzhang Lu, Doctor contact

+86-15295189493

Luxuzhang2008@163.com

China1 site
  • Changzhou No.2 People's Hospital

    Changzhou

    Lu, Doctor, +86-15295189493, Luxuzhang2008@163.com

Other trials in China

About this study

Official title: A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.

Read the detailed description

This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases.

Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.

Being tested
universal allogeneic anti-CD19/BCMA CAR T-cells
Keywords
Universal Allogeneic CAR T-cells, CD19/BCMA CAR T-cells
Medical subject headings
Lupus Erythematosus, Systemic, Anemia, Hemolytic, Autoimmune, Myasthenia Gravis, Scleroderma, Systemic, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Myositis, Immunoglobulin G4-Related Disease

What participants receive

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

  • universal allogeneic anti-CD19/BCMA CAR T-cellsBiological

    A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells

Study groups in NCT06978738
Study groupRoleWhat they receive
UCAR T-cell groupExperimentalA single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells
Receives: Biological: universal allogeneic anti-CD19/BCMA CAR T-cells

What is being measured

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

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

    DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.

    Measured: Within 28 Days After UCAR T-cell Infusion

  2. The total number, incidence, and severity of AEs

    Measured: Up to 90 days After UCAR T-cell Infusion

Secondary outcomes (9)
  1. AIHA:Rates of CR, CRi, PR, ORR

    CR: complete response CRi: Complete Remission with incomplete and compensated hemolysis PR: Partial response ORR: Overall response rate

    Measured: Up to 24 Months After UCAR T-cell Infusion

  2. SLE:SLE Response Index 4 (SRI-4)

    The SRI-4 (SLE Responder Index-4) response was defined as a reduction of at least 4 points in SLEDAI score compared with the baseline level, no new British Isles Lupus Assessment Group (BILAG) A organ domain score or no more than one new BILAG B organ domain score, and no worsening in the Physician's Global Assessment (PGA) (<0.3 points worsening from the baseline level).

    Measured: Up to 24 Months After UCAR T-cell Infusion

  3. SLE: Change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline

    SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index, with a score of 0-6 representing mild disease activity, 7-12 representing moderate disease activity, and 12-16 representing severe disease activity

    Measured: Up to 24 Months After UCAR T-cell Infusion

  4. SSc:Change in the modified Rodnan Skin Score (mRSS) from baseline

    The modified Rodnan Skin Score (mRSS) describes the thickness of skin in 17 anatomic areas rated from 0 to 3, where 3 indicates the most severe thickening.

    Measured: Up to 24 Months After UCAR T-cell Infusion

  5. IIM:The ACR-EULAR Myositis Response Criteria [Total Improvement Score (TIS)]

    Total Improvement Score (TIS) contains Physician Global Activity(PGA),Patient/Parent Global Activity(PtGA),Manual Muscle Testing(MMT) and Health Assessment Questionnaire(HAQ).

    PGA:This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale.

    PtGA:This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale.

    MMT:This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies.

    HAQ:Define the health assessement questionnaire.

    Measured: Up to 24 Months After UCAR T-cell Infusion

  6. AAV: Change in disease activity as measured by Birmingham Vasculitis Activity Score (BVAS)

    The Birmingham Vasculitis Activity (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). A negative percentage change indicated improvement in health.

    Measured: Up to 24 Months After UCAR T-cell Infusion

  7. IgG4-RD:IgG4-Related Disease Responder Index (IgG4-RD RI)

    The IgG4-RD RI detects change in disease activity and identifies improvements/worsening in the same or different organ systems. It encompasses more than 25 organs/sites and records the following for each organ/site: (i) activity trend (through a 0-3 [normal/resolved - worsening] organ/site score); (ii) presence of symptoms due to active disease; (iii) need for urgent care; (iv) presence of damage; and (v) presence of symptoms due to damage. The final activity score at each visit is obtained by summing all organ/site scores (i) and by doubling items needing urgent care (iii). Higher scores represent greater (i.e. worse) disease activity.

    Measured: Up to 24 Months After UCAR T-cell Infusion

  8. MG:Changes of Myasthenia Gravis Activities of Daily Living (MG-ADL) Score

    MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in MG. Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe MG.

    Measured: Up to 24 Months After UCAR T-cell Infusion

  9. MG:Quantitative Myasthenia Gravis Score (QMG)

    The QMG score is a 13-item scale used to quantify disease severity in myasthenia gravis. The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits).

    Measured: Up to 24 Months After UCAR T-cell Infusion

Timeline

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

  1. First posted18 May 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionNov 2028 (estimated)

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
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06978738
Sponsor's protocol ID
QH-CE-01
Status last verified
May 2025
First submitted
28 Apr 2025
Last updated
18 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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