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CAR T-cell Therapy

Engineered T Cells + Pembrolizumab for Pleural Cancer

Phase 1 & 2

Waitlist Available

Led By Marjorie Zauderer, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chemotherapy must have been completed at least 7 days prior to leukapheresis

Any major thoracic or abdominal operation must have occurred at least 28 days before study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing the safety of different doses of modified T cells for patients with malignant pleural disease. They will also test the combination of the T cells with another drug, pembrolizumab, to see what effect it has on the cancer.

Who is the study for?

This trial is for adults with malignant pleural diseases like lung cancer or mesothelioma, who've had at least one prior treatment and show disease progression. They must have a functional pleural catheter, meet specific lab criteria (like certain blood cell counts), not be pregnant or breastfeeding, agree to use contraception, and can't have autoimmune diseases or need daily steroids.Check my eligibility

What is being tested?

The study tests different doses of genetically engineered T cells targeting the antigen Mesothelin in patients with malignant pleural disease. It aims to find a safe dose and observe its effects on the patient's body and cancer. Phase II will combine these T cells with pembrolizumab to further assess effectiveness.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to modified T cells attacking healthy tissue, infusion-related reactions from the T cell therapy or pembrolizumab, fatigue from cyclophosphamide chemotherapy, as well as increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I finished my chemotherapy at least a week ago.

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It has been over 28 days since my last major chest or belly surgery.

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I am able to care for myself but may not be able to do active work.

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My cancer in the lining of the lungs has been confirmed.

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All side effects from my past cancer treatments have mostly gone away.

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I finished palliative radiotherapy at least 2 days before starting cyclophosphamide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite measure of severity and number of adverse events (AEs); changes in (clinical laboratory test findings (hematologic and chemistry); and physical examination. (Phase I)

clinical benefit rate (phase II)

Secondary outcome measures

Changes in serum levels of the biomarker soluble mesothelin related peptide (SMRP) (Phase I)

Side effects data

From 2022 Phase 3 trial • 1274 Patients • NCT02220894

12%

Weight decreased

Alanine aminotransferase increased

Aspartate aminotransferase increased

Decreased appetite

Arthralgia

Constipation

Haemoptysis

Diarrhoea

Hypothyroidism

Nasopharyngitis

Bronchitis

Cough

Asthenia

Pruritus

Anaemia

Pneumonia

Headache

Blood alkaline phosphatase increased

Malaise

Hyperglycaemia

Pneumonia bacterial

White blood cell count decreased

Back pain

Myalgia

Hypertension

Pyrexia

Hyperthyroidism

Upper respiratory tract infection

Nausea

Dyspnoea

Leukopenia

Chest pain

Rash

Subdural haemorrhage

Lymph gland infection

Tumour associated fever

Haematemesis

Upper gastrointestinal haemorrhage

Oedema peripheral

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab Second Course

Pembrolizumab

Chemotherapy (SOC Treatment)

Trial Design

3Treatment groups

Experimental Treatment

Group I: modified T cells with cyclophosphamideExperimental Treatment2 Interventions

Patients will receive cyclophosphamide intravenously (at 1.5 g/m^2) , 2 - 7 (Day (-7) -(-2) days before T cell infusion. On Day 1 , patients will be admitted to the MSKCC Inpatient Service (if not already inpatients) for intravenous hydration, clinical monitoring, and blood work for immune monitoring. Standard MSKCC antiemetic therapy will be administered prior to chemotherapy to prevent nausea/vomiting. Administration of corticosteroids will be avoided as steroids may impede the efficacy of CAR T cells.

Group II: modified T cells alone (without chemotherapy)Experimental Treatment1 Intervention

Following enrollment, leukapheresis product will be obtained in the blood donor facility at MSKCC and cryopreserved in the Cell Therapy and Cell Engineering Facility (CTCEF). Before protocol treatment, the leukapheresis product will be thawed, and T cell isolation, transduction, and expansion of iCasp928z T cells will be performed in the MSKCC CTCEF Facility. It is estimated that it will take approximately 3 to 6 weeks to generate T cells for treatment.

Group III: CAR T cell and pembrolizumabExperimental Treatment1 Intervention

Pembrolizumab 4 weeks (+3/-1 week window) after completing CAR T cell administration. Patients will receive 3 doses of pembrolizumab given on a recurring schedule followed by reassessment. Those responding or deriving clinical benefit, without unacceptable toxicity, will continue pembrolizumab. Patients will be followed weekly for the first four weeks. Patients in cohorts 9 and in Phase II will receive pembrolizumab 4 weeks(+3/- 1 week window) following CAR T cell administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cyclophosphamide

1994

Completed Phase 3

~8140

pembrolizumab

2017

Completed Phase 3

~5750

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,509 Total Patients Enrolled

19 Trials studying Mesothelioma

684 Patients Enrolled for Mesothelioma

Bellicum PharmaceuticalsIndustry Sponsor

27 Previous Clinical Trials

1,239 Total Patients Enrolled

United States Department of DefenseFED

861 Previous Clinical Trials

227,081 Total Patients Enrolled

3 Trials studying Mesothelioma

283 Patients Enrolled for Mesothelioma

Media Library

iCasp9M28z T cell infusions (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02414269 — Phase 1 & 2

Mesothelioma Research Study Groups: modified T cells alone (without chemotherapy), modified T cells with cyclophosphamide, CAR T cell and pembrolizumab

Mesothelioma Clinical Trial 2023: iCasp9M28z T cell infusions Highlights & Side Effects. Trial Name: NCT02414269 — Phase 1 & 2

iCasp9M28z T cell infusions (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02414269 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being signed up to participate in this clinical trial?

"Unfortunately, this particular trial is no longer recruiting patients. The listing was created on May 1st, 2015 and edited for the last time on November 14th, 2022. For those looking for similar studies, there are 1957 trials actively recruiting mesothelioma patients and 1813 pembrolizumab trials with open recruitment at the moment."

Answered by AI

Is this trial limited to the United States, or are other countries participating as well?

"There are 6 active clinical trial sites for this medication, some of which are in Commack, New york and Basking Ridge. To limit the amount of travel required, patients should enroll at the site closest to them."

Answered by AI

Are there any other ongoing pembrolizumab trials that we can compare this to?

"There are 1813 ongoing clinical trials for the use of pembrolizumab. Of these, 277 have reached Phase 3. The largest concentration of trials is in Philadelphia, but there are 63227 locations running clinical trials for pembrolizumab across the globe."

Answered by AI

Are we still looking for individuals to participate in this research?

"This particular clinical trial is not seeking new participants at this time, according to the latest update on November 14th, 2022. However, there are 1957 trials for mesothelioma and 1813 pembrolizumab studies that are currently enrolling patients."

Answered by AI

What indications is pembrolizumab most commonly used for?

"While malignant melanoma of the skin is one condition that can be treated with pembrolizumab, this medication is also useful for treating other illnesses such as recurrent cervical cancer, leukemia, and refractory, relapsed mediastinal large b-cell lymphoma."

Answered by AI