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

Conditions

• Lymphoma, Non-Hodgkin Lymphoma, B-Cell

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BAFF CAR-T — DRUG
  Autologous CAR-T cell therapy expressing the BAFF-ligand.

Study Details

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.

Key Dates

Start date

Nov 21, 2023

Status verified

Oct 2024

Primary completion

May 1, 2025

Completion

Sep 2, 2025

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: LMY-920 dose escalation
  Open label, dose escalation study with up to four dose levels of LMY-920. The maximum tolerated dose (MTD) of LMY-920 will be determined using dose-escalation 3+3 design.

Primary Outcome Measure

To determine recommended phase II dose of human LMY-920. [ Time Frame: 24 months ]

Central Contacts

• Paolo F. Caimi, MD
  216 445-4635
  [email protected]

Locations (2)

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