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NCT03296137

Adoptive Cell Therapy Across Cancer Diagnoses

Completed Phase 1, PHASE2 Results posted Last updated 26 October 2024
What this trial tests

Phase 1, PHASE2 trial testing Autologous tumor-infiltrating lymphocytes in Cancer in 25 participants. Completed in 1 July 2020.

Timeline
13 October 2017
Primary endpoint
13 March 2020
1 July 2020

Quick facts

Lead sponsorInge Marie Svane
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment25
Start date13 October 2017
Primary completion13 March 2020
Estimated completion1 July 2020
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Inge Marie Svane — full company profile →

Who can join

Adults 18 to 70, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants and Type of Reported Adverse Events Primary · 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

Neutropenia
GroupValue95% CI
All Participants25
Trombocytopenia
GroupValue95% CI
All Participants22
Anemia
GroupValue95% CI
All Participants22
Infection
GroupValue95% CI
All Participants6
Hyponatremia
GroupValue95% CI
All Participants2
Hemorrhagic cystitis
GroupValue95% CI
All Participants1
Fatique
GroupValue95% CI
All Participants6
Vertigo
GroupValue95% CI
All Participants1
Time to Disease Progression Secondary · 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

GroupValue95% CI
Treated Participants8912 – 211
Overall Survival Secondary · Until study completion

Duration of survival measured in days after adoptive cell therapy until death or end of follow-up/censoring.

GroupValue95% CI
Treated Participants22750 – 870
Overall Response Rate Secondary · 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.

GroupValue95% CI
Treated Participants2

Adverse events — posted to ClinicalTrials.gov

Time frame: The data was collected throughout the duration of the clinical trial. From October 2017 and until study Completion in july, 2020. For the individual patient, the reporting started at the study enrolment and ended with study exclusion but with a minimum of 6 months follow-up after the adoptive cell therapy or until study completion. Information on adverse events were collected every 6 weeks for the first 3 months and every 3 months hereafter.. Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treated Participants
Serious: 9/25 (36%)
Deaths: 23/25

Serious adverse events (11 terms)

ReactionSystemTreated Participants
ColitisGastrointestinal disorders
Elevated bilirubinHepatobiliary disorders
Urinary tract infectionInfections and infestations
Refractory trombocytopeniaBlood and lymphatic system disorders
ChylosSkin and subcutaneous tissue disorders
Neutropenic feverInfections and infestations
Thrombosis in central katheterBlood and lymphatic system disorders
Upper respiratory tract infectionInfections and infestations
Addisions crisisGeneral disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Infection unknown focusInfections and infestations
Other adverse events (23 terms — click to expand)

ReactionSystemTreated Participants
NeutropeniaBlood and lymphatic system disorders
NauseaGeneral disorders
TrombocytopeniaBlood and lymphatic system disorders
Febrile neutropeniaGeneral disorders
AnemiaBlood and lymphatic system disorders
FatigueGeneral disorders
FeverGeneral disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Oral mucositisInfections and infestations
VomitingGastrointestinal disorders
DiarrheaGastrointestinal disorders
Maculopapular rashSkin and subcutaneous tissue disorders
ObstipationGastrointestinal disorders
InfectionsInfections and infestations
Autoimmune reactionsImmune system disorders
Dry skinSkin and subcutaneous tissue disorders
GranulomaSkin and subcutaneous tissue disorders
Elevated liver enzymesHepatobiliary disorders
Muscle/joint painMusculoskeletal and connective tissue disorders
HallucinationsPsychiatric disorders
EdemaSkin and subcutaneous tissue disorders
HyponatremiaRenal and urinary disorders
VertigoNervous system disorders

Most-reported serious reactions: Colitis, Elevated bilirubin, Urinary tract infection, Refractory trombocytopenia, Chylos, Neutropenic fever, Thrombosis in central katheter, Upper respiratory tract infection.

Data from ClinicalTrials.gov NCT03296137 adverse events section.

Sponsor's own description

This study will perform tumor-infiltrating lymphocyte (TIL)-based adoptive T-cell therapy in combination with checkpoint inhibition on cancer patients across all cancer diagnoses.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. CRISPR/Cas9 mediated deletion of the adenosine A2A receptor enhances CAR T cell efficacy.
    Giuffrida L, Sek K, Henderson MA, Lai J, et al · · 2021 · cited 177× · PMID 34050151 · DOI 10.1038/s41467-021-23331-5
  2. Immune Checkpoint Inhibition for Pancreatic Ductal Adenocarcinoma: Current Limitations and Future Options.
    Kabacaoglu D, Ciecielski KJ, Ruess DA, Algül H. · · 2018 · cited 152× · PMID 30158932 · DOI 10.3389/fimmu.2018.01878
  3. Adoptive cell therapy in combination with checkpoint inhibitors in ovarian cancer.
    Kverneland AH, Pedersen M, Westergaard MCW, Nielsen M, et al · · 2020 · cited 84× · PMID 32547707 · DOI 10.18632/oncotarget.27604
  4. Adoptive cell therapy with tumor-infiltrating lymphocytes supported by checkpoint inhibition across multiple solid cancer types.
    Kverneland AH, Chamberlain CA, Borch TH, Nielsen M, et al · · 2021 · cited 53× · PMID 34607899 · DOI 10.1136/jitc-2021-003499
  5. Long-term follow-up of anti-PD-1 naïve patients with metastatic melanoma treated with IDO/PD-L1 targeting peptide vaccine and nivolumab.
    Lorentzen CL, Kjeldsen JW, Ehrnrooth E, Andersen MH, et al · · 2023 · cited 28× · PMID 37217243 · DOI 10.1136/jitc-2023-006755
  6. Qualitative Analysis of Tumor-Infiltrating Lymphocytes across Human Tumor Types Reveals a Higher Proportion of Bystander CD8<sup>+</sup> T Cells in Non-Melanoma Cancers Compared to Melanoma.
    Gokuldass A, Draghi A, Papp K, Borch TH, et al · · 2020 · cited 28× · PMID 33198174 · DOI 10.3390/cancers12113344
  7. New emerging targets in cancer immunotherapy: the role of neoantigens.
    De Mattos-Arruda L, Blanco-Heredia J, Aguilar-Gurrieri C, Carrillo J, et al · · 2020 · cited 23× · PMID 32269031 · DOI 10.1136/esmoopen-2020-000684
  8. Emerging Approaches for Solid Tumor Treatment Using CAR-T Cell Therapy.
    Chung H, Jung H, Noh JY. · · 2021 · cited 18× · PMID 34830003 · DOI 10.3390/ijms222212126

Verify or expand the search:

Other trials of Autologous tumor-infiltrating lymphocytes

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Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03296137.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing