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NCT02650986 · OUTCOME

Number of Participants With Dose Limiting Toxicities

Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1 · Source last updated 2026-07-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 30 days

What was measured

Will be assessed using Common Toxicity Criteria. Patients will be monitored by medical histories, physical examinations, ophthalmologic exams, and blood studies to detect potential toxicities from the treatment. the number of patients experiencing a DLT are reported.

Groups in this outcome

Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)

Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^7 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV

Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)

Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^8 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV

Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)

Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV

Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)

Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Decitabine: Given IV at 20 mg/m\^2 x 3 days Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)3
Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)3
Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)3
Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)0Not reportedNot reportedNot reportedNot reported
Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)0Not reportedNot reportedNot reportedNot reported
Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)0Not reportedNot reportedNot reportedNot reported
Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Will be assessed using Common Toxicity Criteria. Patients will be monitored by medical histories, physical examinations, ophthalmologic exams, and blood studies to detect potential toxicities from the treatment. the number of patients experiencing a DLT are reported.
groups
  1. description
    Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^7 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
    id
    OG000
    title
    Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
  2. description
    Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^8 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
    id
    OG001
    title
    Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
  3. description
    Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
    id
    OG002
    title
    Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
  4. description
    Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Decitabine: Given IV at 20 mg/m\^2 x 3 days Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis
    id
    OG003
    title
    Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 30 days
title
Number of Participants With Dose Limiting Toxicities
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice