C-TIL051 in Non-Small Cell Lung Cancer
Study Details
Study Description
Brief Summary
The goal of this Phase 1 clinical study is test tumor infiltrating lymphocytes (known as C-TIL051) with anti-PD1 therapy for subjects with refractory non-small cell lung cancer.
The purpose of this study is to:
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Test the safety and ability for subjects to tolerate the TIL therapy
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Measure to see how the NSCLC responds to the TIL therapy
Participants will be asked to:
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Provide a tumor sample prior to the start of any treatment which will be used to make the C-TIL051.
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Receive standard of care treatment until their lung cancer no longer responds
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When necessary, the C-TIL051 will be manufactured by the sponsor and sent back to the site
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Subject will then receive chemotherapy (called lymphodepletion) for 3 days followed by 2 days of rest
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C-TIL051 will then be infused on day 0 followed by interleukin-2
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Pembrolizumab will be administered every 3 weeks for up to 2 years
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: C-TIL051 C-TIL051 plus IL-2 and Pembrolizumab |
Biological: C-TIL051
C-TIL051 given in combination with IL-2 and pembrolizumab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Calculate the Incidence of Adverse Events or Dose Limiting Toxicities [up to 24 months]
Record the incidence and severity of all adverse events or dose limiting toxicities that occur according to CTCAE criteria V5.0
Secondary Outcome Measures
- Calculate Objective Response Rate (ORR) of all Subjects [up to 36 months]
Measure by radiographical imaging (CT/MRI scan) the objective response rate using RECIST 1.1
- Calculate Duration of Response (DOR) of All Subjects [up to 36 months]
Measure by radiographical imaging (CT/MRI scan) the length of response in time.
- Calculate Progression Free Survival (PFS) for All Subjects [up to 36 months]
Measure by radiographical imaging (CT/MRI scan) the length of time to progression of disease.
- Determine Overall Survival (OS) of All Subjects [up to 36 months]
Measure by physical exam and contact reports the overall survival for all subjects following C-TIL051 treatment.
Other Outcome Measures
- Collect Blood Samples to Measure the T-cells Before and After C-TIL051 Therapy [up to 24 months]
Collect blood samples to review information about the t-cells present prior to lymphodepleting chemotherapy and after C-TIL051 therapy.
- Collect Blood Samples to Measure Cytokines prior to and after C-TIL051 Therapy. [up to 24 months]
Collect blood samples and analyze for presence of cytokines at specified intervals before and after treatment with C-TIL051.
- Collect Blood and Tumor Samples to Measure Circulating DNA [up to 24 months]
Collect blood and tumor samples and analyze for circulating DNA.
- Collect Blood Samples to Measure Blood RNA [up to 24 months]
Collect blood samples and analyze for RNA sequencing
- Perform Radiographic Imaging to Review Antitumor Activity Following Treatment [up to 24 months]
Measure by radiographical imaging (CT/MRI scan) and assess response by immune-related response criteria (irRC).
- Collect and Analyze Tumor Samples for MicroOrganoSphereTM (MOS) Technology [up to 36 months]
Collect tumor sample and review outcome measures by MicroOrganoSphereTM (MOS) Technology.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able to understand and give written informed consent
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Histologically and cytologically confirmed diagnosis of stage IV or recurrent non-small cell lung cancer (NSCLC) with adenocarcinoma or squamous histology
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Planned for treatment with an anti-PD1 agent
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Tumor accessible by surgery, previously not irradiated and ≥ 1.5 cm in diameter
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Measurable disease after resection of tumor by RECIST 1.1
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ECOG ≤ 1
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Expected survival > 6 months
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Adequate organ and marrow function
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ECHO, MUGA or cardiac stress test within past 6 months showing LVEF >50% and without evidence of reversible ischemia
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Pulmonary function tests within past 6 months showing DLCO >50% of predicted
Exclusion Criteria:
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Previous treatment with PD1/PDL1 inhibitor for metastatic disease, Immune checkpoint blockade (ICB) given as part of definitive therapy for stage Ib-III disease with surgery or after chemo/radiation is acceptable if last dose of ICB is at least 6 months prior to enrollment in this study.
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Known driver mutations such as EGFR, KRAS G12C, ALK, ROS1, BRAF V600E, RET, METex14, and NTRK alternations.
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Current or prior use of any immunosuppressive medications within 14 days before tumor harvest
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Known active CNS metastases which are symptomatic
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History of leptomeningeal metastases
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Uncontrolled intercurrent illness
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QTc ≥ 470 ms
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Known history of HIV+ or AIDS, hepatitis C, acute or chronic active hepatitis B or other serious chronic infection
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Live vaccine within 30 days of tumor harvest
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History of allogeneic organ transplant
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History of primary immunodeficiency
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Hypersensitivity to anti-PD1 agent, cyclophosphamide, fludarabine, interleukin-2 or any excipient
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Any condition that may interfere with evaluation of study treatment, safety or study results
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Active infection that requires IV antibiotics within 7 days of tumor harvest
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Unresolved greater than grade 1 toxicity (CTCAE v5.0) from previous therapy
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History of interstitial pneumonitis of autoimmune etiology that is symptomatic or requires treatment
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Pulmonary disease history requiring escalating amounts of oxygen > 2L
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Known autoimmune conditions requiring systemic immune suppression therapy other than low dose prednisone or equivalent.
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Other malignancy, other than cutaneous localized) that required active treatment in the last 2 years.
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Women who are pregnant or lactating
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Women of childbearing potential or fertile men unwilling to use effective contraception during study and 6 months after treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke Cancer Institute | Raleigh | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Cellular Biomedicine Group, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CCI-2005