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Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed/Refractory Autoimmune Diseases

ConditionsRefractory/Relapsed Systemic Lupus ErythematosusRefractory / Relapsed / Progressive Systemic SclerosisRefractory / Relapsing / Progressive Inflammatory MyopathyRefractory / Relapsed Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated VasculitisRefractory / Relapsed Connective Tissue Disease-Associated Thrombocytopenia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory autoimmune diseases

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years (including 18 years), no gender restrictions.

Confirmed by flow cytometry to express CD19 or BCMA antigen on the surface of peripheral blood B cells.

Bone marrow function: Neutrophil count ≥ 1 × 10^9/L (no colony-stimulating factor therapy within 2 weeks prior to testing); Haemoglobin ≥ 60 g/L.

Liver function: Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN) (excluding ALT elevation due to inflammatory myopathy) ; Aspartate Aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy); Total Bilirubin (TBIL) ≤ 2 times ULN (may be relaxed to ≤ 3.0 times ULN for subjects with Gilbert's syndrome).

Disqualifiers

-Individuals with a history of severe drug allergies or an allergic constitution.

Presence or suspected presence of uncontrolled or treatable fungal, bacterial, viral, or other infections.

Active, severe central nervous system disorders caused by autoimmune or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).

Patients with cardiac insufficiency.

Trial design

Design model

Single group

Treatments tested in this trial

  • Allogeneic CD19/BCMA-targeted CAR-γδT cell injection

    Biological/Vaccine

    Biological: Allogeneic CD19/BCMA-targeted CAR-γδT cell. Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine), patients will be treated with dose-escalation phase (3+3 design): Dose A (5 × 10\^6 CAR+cells) ,Dose B(1 × 10\^7 CAR+cells), Dose C (1.5 × 10\^7 CAR+cells).

  • Cyclophosphamide

    Drug

    Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (300 mg/m² administered 3 days).

  • Fludarabine

    Drug

    Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30 mg/m² administered 3 days).

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: Patients with relapsed/refractory autoimmune diseasesExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse Event

Time frame
6 months
2

Incidence of Dose-Limiting Toxicities (DLTs)

Time frame
First infusion date of allogeneic CD19/BCMA-targeted CAR-γδT cell to 28 days end cell infusion

Secondary outcomes

1

PK(Pharmacokinetics):Number and Copy Number of CD19/BCMA-targeted CAR-γδT cells

Number and copy number of CD19/BCMA-targeted CAR-γδT cells were assessed by number in peripheral blood. Blood samples were collected before and one year after cell infusion (until CD19/BCMA-targeted CAR-γδT cells were not detected for two consecutive times) to detect the number and copy number of CD19/BCMA-targeted CAR-γδT cells, and to evaluate the pharmacokinetics of CD19/BCMA-targeted CAR-γδT cells.

Time frame
12 months
2

PK(Pharmacokinetics): Persistence of CD19/BCMA-targeted CAR-γδT cells

Persistence of CD19/BCMA -targeted CAR-γδT cells assessed by number in peripheral blood.

Time frame
12 months
3

PD(Pharmacodynamics)：Peak Level of Cytokines in Serum

The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, interferon-γ（IFN-γ). Peak was defined as the maximum post-baseline level of the cytokine.

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov

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