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RecruitingNCT06787989Updated Jan 22, 2025

BCMA-CD19 CCAR T Cell Treatment of Refractory Immune Thrombocytopenia Associated with Autoimmune Diseases

A Phase 1 interventional study of BCMA-CD19 cCAR T cells in Refractory Immune Cytopenia, sponsored by iCell Gene Therapeutics. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by iCell Gene Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2024, registered Jan 2025).
  • Started Aug 2024; still recruiting 2 years 1 month later.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with refractory ITP associated with autoimmune disease.

Read the detailed description

Immune thrombocytopenia (ITP) Can be associated with various autoimmune diseases, including SLE, and SS. Patients with refractory thrombocytopenia often have long hospital stays, high medical costs, high demand for blood products, and are prone to complications of other systemic injuries. Such patients require active treatment to reduce the risk of life-threatening bleeding, delay the progression of the disease prognosis Glucocorticoids combined with immunosuppressive agents are still the main treatment strategies. Recently, biological agents targeting abnormal immune cells, such as rituximab and belimumab, which deplete B cells have also achieved some success in the treatment of ITP. However, these agents cannot permanently reverse the production of abnormal antibodies as they are unable to eliminate pathogenic long-lived plasma cells because these agents cannot penetrate lymph nodes and soft tissue. The BCMA-CD19 cCAR T-cells are designed to deplete antibody-producing 'root", B cells and plasma cells.

02

Conditions studied

  • Refractory Immune Cytopenia

Keywords

  • immune thrombocytopenia
  • CAR T cells
  • BCMA-CD19 cCAR
  • autoimmune diseaases
03

In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's planned enrollment of 20 is below the median of 55 across 472 interventional studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

iCell Gene Therapeutics is the lead sponsor of 16 studies on the registry; 7 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Age: 18\~60 years old; 2. Diagnosed with immune thrombocytopenia associated with autoimmune diseases including systemic lupus erythematosus (according to the 1997 or 2009 ACR classification criteria), primary Sjogren's syndrome (according to the 2002 ACR/EULAR international classification criteria), undifferentiated connective tissue disease (according to the 1999 international classification criteria). Or patient without clinical manifestations related to connective tissue disease, but with positive anti nuclear antibodies (≥ 1:100) and/or without positive anti SSA/Ro-52 antibodies;Serum creatinine \<221.0μmol/L (2.5mg/dl); 3. platelet count\<30 × 10 ⁹/L or platelet count ≥ 20 × 10 ⁹/L, accompanied by bleeding symptoms (bleeding symptom score ≥ 2 points). No obvious active infection; 4. Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative.

Exclusion criteria

Exclusion Criteria:

    1. Serious accompanying diseases that researchers consider clinically significant due to poor control, such as (but not limited to) neurological, cardiovascular, renal, liver, endocrine, or gastrointestinal diseases CNS disease: Active central nervous system (CNS) lupus (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNS vasculitis), visual Disorders, cranial neuropathy requiring intervention 2. Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) detection value is greater than 1.5 times the upper limit of normal (ULN);; urinary protein quantification>1g/24h.
  1. History of malignant tumors 4. Active hepatitis B or C.,and HIV positive 5. Individuals with a history of drug allergies or allergies. 6. Have any other clinically significant disease history or current disease that, in the judgment of the research physician, may pose a risk to the safety of the subjects, or interfere with the completion of the research procedure and the evaluation of safety and efficacy.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    BCMA-CD19 cCAR T cells

    Dose escalation phase: patient's T cells will be transduced with a retroviral vector to express a BCMA-CD19 cCAR. with an escalation approach.

    Biological: BCMA-CD19 cCAR T cells

Interventions

  • BiologicalBCMA-CD19 cCAR T cells

    • BCMA-CD19 cCAR T cells are used to treat patients. Patient will be administered either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

06

What researchers measure

Primary outcomes

  1. The number and incidence of adverse events after BCMA-CD19 cCAR T cell infusion

    Evaluation all possible adverse reactions, including the number, incidence, and severity of symptoms such as cytokine release syndromes and neurotoxicity within 3 months after BCMA-CD19 cCAR infusion.

    Time frame: 24 months

Secondary outcomes

  1. Overall remission rate 12 weeks after BCMA-CD19 cCAR

    1. Complete response (CR): Platelet count ≥ 100 × 109/L and no bleeding; 2. Partial response (PR): platelet count\<100 × 109/L, but increased by at least 2 times compared to baseline platelet count, with no bleeding symptoms 3. Disease control: Disease control monitored up to 2 years after BCMA-CD19 cCAR T cells infusion)

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • West China Hospital
    Chengdu, Sichuan 610041, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06787989
Lead sponsor
iCell Gene Therapeutics
Collaborators
iCell ImmunityX(Hangzhou)Co., Ltd.
Responsible party
Sponsor
First posted
Jan 22, 2025
Start date
Aug 31, 2024
Primary completion
Aug 2026 (estimated)
Completion
Apr 2027 (estimated)
Last update
Jan 22, 2025

Study contacts

Qibing Xie, MD
Contact
xieqibing1971@163.com
0118618980601299
Min Yang, MD
Contact
yangmin7911@126.com
13618028207

Oversight

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

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