Trial · NCT02111850
T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive
NCT02111850, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2022-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive. Trials, record NCT02111850. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02111850
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive
- NCT number
- NCT02111850
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Cervical Cancer, Renal Cancer, Urothelial Cancer, Melanoma, Breast Cancer
- Interventions
- Anti-MAGE-A3-DP4 T Cell Receptor (TCR) Peripheral Blood Lymphocytes (PBL), Cyclophosphamide, Fludarabine, Aldesleukin
- First posted
- 2014-04-11
- Last updated
- 2022-03-29
- Results first posted
- 2022-03-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Cell Dose (MTD) of Cluster of Differentiation 4 (CD4) Cells Transduced With an Anti-MAGE-A3-DP0401/0402 Restricted (MAGE-A3-DP4) T Cell Receptor and Aldesleukin | Before progression to next-higher dose level, at least two weeks | Highest dose at which less than or equal to 1 of 6 patients experienced a dose-limiting toxicity (DLT) (all grade 3 and greater toxicities with the exception of myelosuppression and grade 3 fever, for example) or the highest dose level studied if DLTs are not observed at any of the dose levels. |
| Primary | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x2 years, then per principal investigator discretion, approximately 6 years | Percentage of participants who have a clinical response to treatment (objective tumor regression) measured by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter of target lesions. Progression is at least a 20% increase in the sum of longest diameter of target lesions or the appearance of one or more new lesions. And stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. |
| Primary | Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment | 6 weeks after cell infusion | Aggregate of all adverse events with Grades ≥1 that are possibly, probably, and/or definitely related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse events. |
| Secondary | Number of Engineered T Cell Receptor (TCR) Cells That Survived at 4 Weeks | 4 weeks | T cell receptor (TCR) and vector presence was quantitated in peripheral blood mononuclear cells (PBMC) samples using flow cytometry. It is a process by which cells are suspended in a liquid so they can be counted. |
| Other | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Date treatment consent signed to date off study, an average of 17 months | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Other | Number of Participants With Dose-limiting Toxicity (DLT) | Before progression to next-higher dose level, approximately 2 weeks | A dose-limiting toxicity (DLT) is all grade 3 and greater toxicities with the exception of myelosuppression, aldesleukin expected toxicities, expected chemotherapy toxicities, immediate hypersensitivity reactions occurring within 2 hours of cell infusion, grade 3 fever, grade 3 metabolic laboratory abnormalities without significant clinical sequela that resolve within grade 2 within 7 days, and grade 3 autoimmunity that resolves to less than or equal to a grade 2 autoimmune toxicity within 10 days. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Cell Dose (MTD) of Cluster of Differentiation 4 (CD4) Cells Transduced With an Anti-MAGE-A3-DP0401/0402 Restricted (MAGE-A3-DP4) T Cell Receptor and Aldesleukin | Before progression to next-higher dose level, at least two weeks | cells | NUMBER | |
| PRIMARY | Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x2 years, then per principal investigator discretion, approximately 6 years | One participant was not evaluable because the participant did not receive cell infusion. | percentage of participants | NUMBER |
| PRIMARY | Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment | 6 weeks after cell infusion | There are no Grade 1 and 5 adverse events related to treatment. | adverse events | NUMBER |
| SECONDARY | Number of Engineered T Cell Receptor (TCR) Cells That Survived at 4 Weeks | 4 weeks | One participant was not evaluable because the participant did not receive cell infusion.~One participant was not analyzed because samples was not collected for the Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10\^8 Cells + Interleukin-2 Arm/Group. | cells/uL | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Date treatment consent signed to date off study, an average of 17 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Dose-limiting Toxicity (DLT) | Before progression to next-higher dose level, approximately 2 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1,123
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Cell Dose (MTD) of Cluster of Differentiation 4 (CD4) Cells Transduced With an Anti-MAGE-A3-DP0401/0402 Restricted (MAGE-A3-DP4) T Cell Receptor and Aldesleukin | All Participants on Phase 1 | 100,000,000,000 | cells | ||
| Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2 | Complete Response | 0 | percentage of participants | |
| Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2 | Complete Response | 0 | percentage of participants | |
| Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2 | Complete Response | 0 | percentage of participants | |
| Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2 | Complete Response | 0 | percentage of participants | |
| Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2 | Complete Response | 0 | percentage of participants | |
| Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2 | Complete Response | 100 | percentage of participants | |
| Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2 | Complete Response | 0 | percentage of participants | |
| Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2 | Complete Response | 0 | percentage of participants | |
| Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression) | Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2 | Complete Response | 0 | percentage of participants |
1 to 10 of 1,123Source ClinicalTrials.gov
See all 1,123 results by groupParticipant flow66
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 Dose Escalation | STARTED | Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2 | 1 | |
| Phase 1 Dose Escalation | STARTED | Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2 | 1 | |
| Phase 1 Dose Escalation | STARTED | Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2 | 1 | |
| Phase 1 Dose Escalation | STARTED | Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2 | 1 | |
| Phase 1 Dose Escalation | STARTED | Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2 | 2 | |
| Phase 1 Dose Escalation | STARTED | Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2 | 1 | |
| Phase 1 Dose Escalation | STARTED | Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2 | 1 | |
| Phase 1 Dose Escalation | STARTED | Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2 | 1 | |
| Phase 1 Dose Escalation | STARTED | Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2 | 6 | |
| Phase 1 Dose Escalation | STARTED | Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 participant flowAdverse events770
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 | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2 | 0 | 1 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2 | 0 | 1 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2 | 0 | 1 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2 | 0 | 1 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2 | 1 | 2 | 1 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2 | 0 | 1 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2 | 0 | 1 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2 | 0 | 1 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2 | 0 | 6 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other | 0 | 5 | 0 |
1 to 10 of 770Source ClinicalTrials.gov
See all 770 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2 | 1 | 1 |
| Total, all-cause mortality | Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2 | 1 | 1 |
| Total, all-cause mortality | Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2 | 0 | 1 |
| Total, all-cause mortality | Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2 | 1 | 1 |
| Total, all-cause mortality | Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2 | 1 | 2 |
| Total, all-cause mortality | Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2 | 0 | 1 |
| Total, all-cause mortality | Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2 | 1 | 1 |
| Total, all-cause mortality | Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2 | 1 | 1 |
| Total, all-cause mortality | Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2 | 5 | 6 |
| Total, all-cause mortality | Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other | 4 | 5 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02111850
GET https://conductscience.org/api/trials/v1/NCT02111850/results?page=2