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MOv19-BBz CAR T Cells in FRa+ Cancers

NCT07116057 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-10-10

No results posted yet for this study

Summary

This is a Phase I open-label clinical trial to assess the safety, feasibility, and preliminary efficacy of intrapleural administration of MOv19-BBz CAR T cells in patients with FRa+ cancers. This study will be initiated in patients with metastatic or recurrent non-small cell lung cancer (NSCLC) only. Subjects will receive a single dose of MOv19-BBz CAR T cells via intrapleural infusion following lymphodepleting chemotherapy. Subjects without an existing intra-pleural catheter will have a temporary pleural catheter placed for the study. Subjects may initiate treatment with commercial checkpoint inhibitors per routine care beginning at least 28 days after receiving MOv19-BBz CAR T cells.

Conditions

Interventions

BIOLOGICAL

MOv19-BBz CAR T cells

Autologous T cells engineered to express an extracellular single chain variable fragment (scFv) with FRa specificity.

DRUG

Cyclophosphamide/Fludarabine

Cytotoxic chemotherapy agents used for lymphodepletion prior to MOv19-BBz CAR T cell administration.

DEVICE

FRa Expression Testing

Laboratory Developed Test used to determine subject eligibility

Sponsors & Collaborators

Principal Investigators

  • Andrew Haas, MD, PhD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-07
Primary Completion
2040-10-31
Completion
2040-10-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT07116057 on ClinicalTrials.gov