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Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma

NCT05312801 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-21

No results posted yet for this study

Summary

Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory lymphoma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory lymphoma, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment.

This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against relapsed non-Hodgkin lymphoma using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.

Conditions

  • Lymphoma, Non-Hodgkin Lymphoma, B-Cell

Interventions

DRUG

BAFF CAR-T

Autologous CAR-T cell therapy expressing the BAFF-ligand.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    collaborator OTHER

  • Luminary Therapeutics

    lead INDUSTRY

Principal Investigators

  • Paolo F. Caimi, MD · Cleveland Clinic Taussig Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2025-05-01
Completion
2025-09-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05312801 on ClinicalTrials.gov