Health TrialsbyHealthPanel

MOv19-BBz CAR T Cells in FRa+ Cancers

ConditionsMetastatic Non Small Cell Lung CancerRecurrent Lung Non-Small Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent form

Documentation of tumor FRa expression by IHC at the Hospital of the University of Pennsylvania (≥ 10% of tumor cells). Subjects must have archived tumor tissue available.

Patients must have evidence of active disease as defined by RECIST 1.1 criteria

Patients with asymptomatic CNS metastases that have been treated (and are off steroids for the treatment of CNS disease) are allowed. They must meet the following criteria

Disqualifiers

Any clinically significant pleural effusion that cannot be drained with standard approaches.

Patients with radiographic evidence of greater than lobar lymphangitic pulmonary involvement, greater than lobar bronchial wall thickening suggestive of peribronchial lymphatic disease extension, and/or evidence of extensive bilateral parenchymal metastatic burden.Note: "Greater than lobar" = "in more than 1 lobe".

Patients with radiographic and/or clinical evidence of active radiation pneumonitis.

Patients with radiographic evidence of underlying interstitial lung disease, including evidence of unresolved drug toxicity from any agent (e.g. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc.).

Trial design

Design model

Sequential

Treatments tested in this trial

  • MOv19-BBz CAR T cells

    Biological/Vaccine

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

  • Cyclophosphamide/Fludarabine

    Drug

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

  • FRa Expression Testing

    Device

    Laboratory Developed Test used to determine subject eligibility

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Dose Level 1 (DL1)Experimental treatment 3 interventions
Group B: Dose Level -1 (DL-1)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events as assessed by CTCAE V5.0

Type, frequency, severity, and attribution of adverse events.

Time frame
Up to 15 years post-MOv19-BBz CAR T cell administration
2

Occurrence of treatment-limiting toxicities (TLTs)

Unacceptable toxicity as defined by the protocol.

Time frame
28 days post-MOv19-BBz CAR T cell administration

Secondary outcomes

1

Evaluate study feasibility

The proportion of enrolled subjects who are confirmed eligible and who receive study treatment as planned.

Time frame
6 months
2

Objective Response Rate (ORR)

Proportion of subjects with confirmed CR or PR per RECIST 1.1 criteria.

Time frame
Up to 12 months following treatment with MOv19-BBz CAR T cells
3

Duration of Response (DOR)

Time from the date when confirmed CR or PR is first met, to the date of confirmed progressive disease, death due to any cause, or receipt of alternative anticancer therapy (excluding commercial immune checkpoint inhibitors as described by the study protocol); or it will be censored at the date of the last adequate assessment (whichever occurs first).

Time frame
Up to 15 years following treatment with MOv19-BBz CAR T cells
4

Progression Free Survival (PFS)

Duration from study treatment to disease progression, receipt of alternative anti-cancer therapy, or death.

Time frame
Up to 15 years following treatment with MOv19-BBz CAR T cells

Other outcomes

Sponsors and contacts

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

University of Pennsylvania

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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