Trial · NCT03296137
Adoptive Cell Therapy Across Cancer Diagnoses
NCT03296137, Phase 1, Phase 2, Completed, Inge Marie Svane; results first posted 2024-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adoptive Cell Therapy Across Cancer Diagnoses. Trials, record NCT03296137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03296137
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adoptive Cell Therapy Across Cancer Diagnoses
- NCT number
- NCT03296137
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Inge Marie Svane
- Conditions
- Cancer
- Interventions
- Autologous tumor-infiltrating lymphocytes, Ipilimumab, Nivolumab, proleukin, Cyclophosphamide, Fludara
- First posted
- 2017-09-28
- Last updated
- 2024-10-26
- Results first posted
- 2024-10-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants and Type of Reported Adverse Events | Up to 2,5 years from begin of study | Determine the safety of the administration of TIL therapy including checkpoint inhibitors, lymphodepleting chemotherapy and Interleukin-2 for patients with cancer by reporting grade \>2 adverse events according to CTCAE v. 4.0 |
| Secondary | Time to Disease Progression | Until study completion | Days of follow-up from TIL infusion until progressive cancer disease, end of follow-up or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Overall Survival | Until study completion | Duration of survival measured in days after adoptive cell therapy until death or end of follow-up/censoring. |
| Secondary | Overall Response Rate | The patients were evaluated every 6-12 weeks (median 90 days) and after therapy and until study completion (max 220 days). | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CAT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants and Type of Reported Adverse Events | Up to 2,5 years from begin of study | Patients who received TIL therapy | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Disease Progression | Until study completion | Days | MEDIAN | |
| SECONDARY | Overall Survival | Until study completion | Days | MEDIAN | |
| SECONDARY | Overall Response Rate | The patients were evaluated every 6-12 weeks (median 90 days) and after therapy and until study completion (max 220 days). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants and Type of Reported Adverse Events | All Participants | Neutropenia | 25 | Participants | |
| Number of Participants and Type of Reported Adverse Events | All Participants | Trombocytopenia | 22 | Participants | |
| Number of Participants and Type of Reported Adverse Events | All Participants | Anemia | 22 | Participants | |
| Number of Participants and Type of Reported Adverse Events | All Participants | Infection | 6 | Participants | |
| Number of Participants and Type of Reported Adverse Events | All Participants | Hyponatremia | 2 | Participants | |
| Number of Participants and Type of Reported Adverse Events | All Participants | Hemorrhagic cystitis | 1 | Participants | |
| Number of Participants and Type of Reported Adverse Events | All Participants | Fatique | 6 | Participants | |
| Number of Participants and Type of Reported Adverse Events | All Participants | Vertigo | 1 | Participants | |
| Number of Participants and Type of Reported Adverse Events | All Participants | Performance status drop | 4 | Participants | |
| Number of Participants and Type of Reported Adverse Events | All Participants | Thrombosis | 1 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 25 | |
| Overall Study | COMPLETED | All Participants | 25 | |
| Overall Study | NOT COMPLETED | All Participants | 0 |
Source ClinicalTrials.gov
Adverse events34
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 | Neutropenia | Blood and lymphatic system disorders | Treated Participants | 25 | 25 | 28 |
| other | Trombocytopenia | Blood and lymphatic system disorders | Treated Participants | 23 | 25 | |
| other | Anemia | Blood and lymphatic system disorders | Treated Participants | 22 | 25 | 28 |
| other | Fatigue | General disorders | Treated Participants | 20 | 25 | 20 |
| other | Nausea | General disorders | Treated Participants | 24 | 25 | 24 |
| other | Vomiting | Gastrointestinal disorders | Treated Participants | 12 | 25 | |
| other | Diarrhea | Gastrointestinal disorders | Treated Participants | 10 | 25 | |
| other | Obstipation | Gastrointestinal disorders | Treated Participants | 6 | 25 | |
| other | Oral mucositis | Infections and infestations | Treated Participants | 14 | 25 | 23 |
| other | Maculopapular rash | Skin and subcutaneous tissue disorders | Treated Participants | 8 | 25 | 10 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treated Participants | 23 | 25 |
| Total, other adverse events | Treated Participants | 25 | 25 |
| Total, serious adverse events | Treated Participants | 9 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34607899 | DERIVED |
Source PubMed
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
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/NCT03296137
GET https://conductscience.org/api/trials/v1/NCT03296137/results?page=2