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About
Study to investigate the safety and activity of NEO-PTC-01 in patients with unresectable or metastatic melanoma. NEO-PTC-01 is an autologous personalized T cell (PTC) product for adoptive cell therapy that is manufactured ex vivo and targets neoantigens displayed on the patient's tumor and the tumor microenvironment.
The study will be conducted in two parts, Part 1 (Dose Finding) and Part 2 (Dose Expansion). The dose-finding part of the study will test two doses of NEO-PTC-01 and will be structured according to a 3+3 dose escalation design. After the highest tolerated NEO-PTC-01 dose is identified, 2 additional evaluations in Part 1 are planned, a cohort to investigate NEO-PTC-01 in combination with interleukin (IL)-2 and another cohort introducing α programmed cell death protein 1 (αPD-1) therapy. The dose expansion part of the study will test the dose deemed to be safe in the dose-finding part of the study in an expanded cohort of patients to further define the safety of NEO-PTC-01.
Enrollment
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Inclusion criteria
Adult (age 18 to 75) men and women willing and able to give written informed consent.
Histologically confirmed unresectable or metastatic melanoma.
Part 1:
Part 2:
For known serine-threonine kinase (BRAF) mutant patients: patients must have also received targeted therapy (B-raf inhibitor or B-raf/mitogen-activated protein kinase enzyme [MEK] combination therapy) prior to NEO-PTC-01, unless deemed not appropriate to receive these treatments by the investigator.
Have at least one site of measurable disease by RECIST v1.1.
At least one site of disease must be accessible to biopsy for tumor tissue for sequence and immunological analysis. The biopsy site may be the same as the measurable site so long as it remains measurable. Surgical resection of the measurable site may not be performed if that site is the only measurable lesion. An archival biopsy may be used in place if the biopsy was taken within 6 months of informed consent.
Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicities see below limits for inclusion) or an National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, Grade of 0 or 1, except for toxicities not considered by the treating physician to be a safety risk (e.g., alopecia).
Screening laboratory values must meet the following criteria and should be obtained prior to any production phase assessments:
Exclusion criteria
Age greater than 75 years or less than 18 years.
Received more than three prior lines of therapy for metastatic disease.
Have an active or history of autoimmune disease (known or suspected). Exceptions are permitted for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to enrollment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to enrollment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical and/or radiographic stability.
Active systemic infections requiring intravenous antimicrobial therapy, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, clinically significant cardiac arrhythmias such as uncontrolled atrial fibrillation, ventricular tachycardia, or second- or third-degree heart block, and obstructive or restrictive pulmonary disease.
Active major medical illnesses of the immune system including conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to NEO-PTC-01 infusion. Inhaled or topical steroids and adrenal replacement doses (≤ 10 mg daily prednisone equivalents) are permitted in the absence of active autoimmune disease.
Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, and/or life-threatening illnesses unrelated to cancer that could, in the investigator's opinion, interfere with participation in this study.
Have any underlying medical condition, psychiatric condition, or social situation that, in the investigator's opinion, would interfere with participation in the study.
Have a planned major surgery that is expected to interfere with study participation or confound the ability to analyze study data.
Are pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the end of the trial (EOT) visit. Nursing women are excluded from this study because there is an unknown but potential risk of AEs in nursing infants secondary to treatment of the mother with treatments to be administered in this study.
Have a history of another invasive malignancy aside from melanoma, except for the following circumstances:
Primary purpose
Allocation
Interventional model
Masking
72 participants in 5 patient groups
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BioNTech clinical trials patient information
Data sourced from clinicaltrials.gov
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