Trial · NCT02774291
Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes
NCT02774291, Early phase 1, Terminated, Albert Einstein College of Medicine; results first posted 2023-08-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes. Trials, record NCT02774291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02774291
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes
- NCT number
- NCT02774291
- Status
- Terminated
- Phases
- Early phase 1
- Enrollment
- 3 participants, actual
- Lead sponsor
- Albert Einstein College of Medicine
- Conditions
- HLA-A2 Positive Cells Present, Metastatic Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain
- Interventions
- Aldesleukin, Anti-thyroglobulin mTCR-transduced Autologous Peripheral Blood Lymphocytes, Cyclophosphamide, Filgrastim, Fludarabine Phosphate, Laboratory Biomarker Analysis
- First posted
- 2016-05-17
- Last updated
- 2023-08-04
- Results first posted
- 2023-08-04
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Toxicity Graded According to NCI-CTCAE Version 4.0 | Up to 15 years | Toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. |
| Secondary | Number of Participants Demonstrating in Vivo Survival of TCR Gene-engineered Cells | 6 weeks post evaluations scan and at 3, 6, and 12 months and annually thereafter | TCR and vector presence will be quantitated in PBMC samples (5-10mL) using established PCR techniques. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells. In addition, measurement of CD4+ and CD8+ T-cells will be conducted and studies of these T-cell subsets in the circulation will be determined by using specific PCR assays capable of detecting the unique DNA sequence for each retroviral vector engineered T-cell. Descriptive statistics will be used to determine the in vivo survival of TCR gene-engineered cells. |
| Secondary | Number of Participants Demonstrating Objective Response Rate (Complete Response + Partial Response) Using RECIST Criteria | Up to 15 years | Objective Response Rate will be graded based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study Descriptive statistics will be used to determine the objective response rate. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Toxicity Graded According to NCI-CTCAE Version 4.0 | Up to 15 years | The study was officially closed on 7/1/2020 as documented on the final progress report dated 8/4/2020. Data for this Outcome Measure limited to 3 participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Demonstrating in Vivo Survival of TCR Gene-engineered Cells | 6 weeks post evaluations scan and at 3, 6, and 12 months and annually thereafter | Data was never collected/aggregated and in vivo survival of TCR gene-engineered cells outcome measure was never analyzed due to the limited number of participants and early termination. The study was officially closed on 7/1/2020 as documented on the final IRB progress report dated 8/4/2020. | ||
| SECONDARY | Number of Participants Demonstrating Objective Response Rate (Complete Response + Partial Response) Using RECIST Criteria | Up to 15 years | Data to support the Objective Response Rate outcome measure was never collected and analyzed due to the limited number of participants enrolled and early termination. The study was officially closed on 7/1/2020 as documented on the final progress report dated 8/4/2020. |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Toxicity Graded According to NCI-CTCAE Version 4.0 | Treatment (mTCR, Aldesleukin) | 2 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (mTCR, Aldesleukin) | 3 | |
| Overall Study | COMPLETED | Treatment (mTCR, Aldesleukin) | 2 | |
| Overall Study | NOT COMPLETED | Treatment (mTCR, Aldesleukin) | 1 |
Source ClinicalTrials.gov
Adverse events37
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Treatment (mTCR, Aldesleukin) | 2 | 3 | |
| other | Edema limbs | General disorders | Treatment (mTCR, Aldesleukin) | 1 | 3 | 2 |
| other | Weight Gain | Investigations | Treatment (mTCR, Aldesleukin) | 2 | 3 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (mTCR, Aldesleukin) | 1 | 3 | |
| other | Vomiting | Gastrointestinal disorders | Treatment (mTCR, Aldesleukin) | 2 | 3 | |
| other | Nausea | Gastrointestinal disorders | Treatment (mTCR, Aldesleukin) | 1 | 3 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Treatment (mTCR, Aldesleukin) | 1 | 3 | 1 |
| other | Chills | General disorders | Treatment (mTCR, Aldesleukin) | 2 | 3 | 2 |
| other | Hypotension | Vascular disorders | Treatment (mTCR, Aldesleukin) | 2 | 3 | |
| other | Sinus Tachycardia | Cardiac disorders | Treatment (mTCR, Aldesleukin) | 1 | 3 |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (mTCR, Aldesleukin) | 2 | 3 |
| Total, other adverse events | Treatment (mTCR, Aldesleukin) | 2 | 3 |
| Total, serious adverse events | Treatment (mTCR, Aldesleukin) | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA013330 | Cancer Center Support Grant | STEIDL, ULRICH | ALBERT EINSTEIN COLLEGE OF MEDICINE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02774291
GET https://conductscience.org/api/trials/v1/NCT02774291/events?page=2