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A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies.

ConditionsOvarian CancerAdvanced Malignant Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

This phase I/IIA trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult subjects (18 years and older) with histologically or cytologically of advanced (metastatic or inoperable) advanced solid tumors.

Tumor (either an archival specimen or a fresh biopsy) shows NY-ESO-1 expression of 1+ by IHC (H-score). NY-ESO-1 expression must be confirmed by central validated assay.

Has received platinum containing chemotherapy and has platinum refractory or resistant disease that has progressed on second line therapy

If platinum sensitive disease, should have received ≥2 lines of chemotherapy.

Disqualifiers

Patients who are receiving any other investigational agents.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.

Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure with New York Heart Association class III or IV disease, patients with a LVEF < 45%, a myocardial infarction within 6 months prior to study entry or a history of myocarditis, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Patients with active autoimmune disease requiring doses of corticosteroids of ≥ 10 mg/day of prednisone (or its equivalent) or other immunosuppressive treatments.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Decitabine

    Drug

    Decitabine taken by mouth 15 mg/m2/day x 5 days, IV; Days -10 to -6

  • Cyclophosphamide Conditioning

    Drug

    Cyclophosphamide Conditioning will be 45 mg/kg x 2 days IV; Days -4 \& -3

  • NY-ESO-1 TCR/ dnTGFβRII

    Biological/Vaccine

    The dose of NY-ESO-1 TCR/ dnTGFβRII to be tested will vary depending on assigned arm.

  • Aldesleukin

    Drug

    Aldesleukin taken by mouth500,000 IU/m2 SC BID; Days +1 to +10

Treatment groups

24 Participants
are divided into 4 treatment groups
Group A: Lead-in cohortExperimental treatment 4 interventions
Group B: Dose Level -1Experimental treatment 4 interventions
Group C: Expansion Cohort A (Ovarian)Experimental treatment 4 interventions
Group D: Expansion Cohort B (Other Solid Tumors)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

To evaluate autologous in the number of participants with treatment-related adverse events.

To evaluate the safety and tolerability of the autologous NY-ESO-1/ dnTGFβRII engineered T cell therapy in combination with decitabine and low-dose IL2 in patients with advanced malignancies. The irRECIST will be used for tumor response assessment performed at 6 weeks, 3 months, 6 months and 9 months.

Time frame
2 years

Secondary outcomes

1

To evaluate modified cells using immune- related Response Evaluation Criteria in Solid Tumors (irRECIST).

To evaluate the persistence of genetically modified cells in the peripheral blood, and at tumor sites (where available). The irRECIST will be used for tumor response assessment performed at 6 weeks, 3 months, 6 months and 9 months.

Time frame
2 years
2

Objective response rate (ORR) tumor effect

To examine the effect of the treatment on tumor as measured by objective response rate (ORR) assessed by immune- related Response Evaluation Criteria in Solid Tumors (irRECIST).

Time frame
6 weeks, 3 months, 6 months and 9 months.
3

Progression free survival (PFS) tumor effect

To examine the effect of the treatment on tumor as measured by progression free survival (PFS), assessed by immune- related Response Evaluation Criteria in Solid Tumors (irRECIST).

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 9 months.

Other outcomes

Sponsors and contacts

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

University of Chicago

Lead sponsor

Source ClinicalTrials.gov
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