A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory at Memorial Sloan Kettering to be changed (modified) to become MSLN-targeted CAR T cells, the CAR T-cell therapy that participants will receive during the study. Participant study therapy will take about 3-4 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years

Diagnosis of pathologically confirmed EG adenocarcinoma

Diagnosis of metastatic or recurrent disease

ECOG performance status of 0-1

Disqualifiers

Pregnant or lactating

HIV, active hepatitis C virus, or active hepatitis B virus infection, as determined by quantitative PCR (patients who have undergone negative testing prior to leukapheresis do not require repeat testing)

Receiving therapy for concurrent active malignancy

Note: Patients receiving treatment for in situ skin malignancies are not excluded.

Trial design

Design model

Single group

Treatments tested in this trial

  • M28z1XXPD1DNR CAR

    Biological/Vaccine

    Participants with esophagastric adenocarcinoma will be treated with an intraperitoneal infusion of different doses of autologous T cells that have been genetically modified ex vivo to express the M28z1XXPD1DNR CAR. The CAR T cells will be manufactured in MSK's Center for Cell Engineering.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Participants with Mesothelin-Positive Esophagogastric Adenocarcinoma with Peritoneal CarcinomatosisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of treatment-emergent adverse events

The primary objective of this study is to assess the safety of M28z1XXPD1DNR CAR T cells administered through the peritoneal cavity. CTCAE v5.0 will be used to assess the severity of all treatment-emergent toxicities and adverse events, regardless of reporting requirements

Time frame
1 year
2

Maximum Tolerated Dose of M28z1XXPD1DNR CAR T cells

Determine the maximum tolerated dose of M28z1XXPD1DNR CAR T cells administered through the peritoneal cavity.

Time frame
Up to 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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