NCT06752876

Brief Summary

This is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
16mo left

Started Dec 2027

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
2.9 years until next milestone

Study Start

First participant enrolled

December 1, 2027

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

December 18, 2024

Last Update Submit

September 16, 2025

Conditions

Systemic Lupus ErythematosusLupusLupus ErythematosusLupus Nephritis

Keywords

CB-010Lupus nephritisLupusExtrarenal lupusAutoimmune diseaseAnti-CD19 CAR-T therapyCell therapy

Outcome Measures

Primary Outcomes (2)

  • Incidence of critical safety events (CSEs) ≤ 28days after CB-010 infusion

    Through 28 days

  • Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)

    Through end of study (approximately 2 years)

Secondary Outcomes (1)

  • To characterize the PK profile of a single infusion of CB-010 (i.e., CB-010 expansion and persistence)

    Through end of study (approximately 2 years)

Study Arms (2)

Cohort 1 Lupus Nephritis (LN)

EXPERIMENTAL
Drug: CB-010

Cohort 2 Extrarenal Lupus (ERL)

EXPERIMENTAL
Drug: CB-010

Interventions

CB-010DRUG

CB-010 allogeneic CAR-T cell therapy, Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion

Cohort 1 Lupus Nephritis (LN)Cohort 2 Extrarenal Lupus (ERL)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of SLE according to 2019 EULAR/ACR classification criteria for at least 6 months
  • Cohort 1 LN:
  • Class III or IV lupus nephritis
  • Urine protein-to-creatinine ratio (UPCR) ≥ 0.8 mg/mg
  • Refractory to glucocorticoids and at least 2 immunosuppressive therapies
  • Cohort 2 ERL (Patients with class I and II LN may be included in the ERL cohort if their SLEDAI-2K is ≥ 8):
  • SLEDAI-2K ≥ 8
  • Refractory to glucocorticoids, and at least 2 immunosuppressive therapies
  • Adequate renal, hepatic, pulmonary, and cardiac function, with specific laboratory criteria
  • Females must be either of nonchildbearing potential, defined as postmenopausal or surgically sterile or agree to use a highly effective double barrier method of contraception or vasectomized partner

You may not qualify if:

  • Has active severe central nervous system (CNS) lupus in the previous 3 months from planned LD start date
  • Has received any other investigational treatment for any indication within the 4 weeks or 5 half-lives
  • Prior treatment with cellular therapy (genetically modified cells), gene therapy directed at any target, allogenic or autologous stem cell transplant or organ transplant
  • History of infection with human immunodeficiency virus or evidence of hepatitis B or C virus infection
  • History of hypersensitivity to Cyclophosphamide, Fludarabine, or any of the components of CB-010
  • Received a live vaccine ≤ 6 weeks prior to start of LD
  • Patients for whom magnetic resonance imaging (MRI) studies are contraindicated or who cannot tolerate them

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lupus Erythematosus, SystemicLupus NephritisAutoimmune Diseases

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesGlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2024

First Posted

December 31, 2024

Study Start (Estimated)

December 1, 2027

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

September 19, 2025

Record last verified: 2025-09