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ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) to Patients With Metastatic Melanoma
Phase 1 trial testing Cyclophosphamide in Malignant Melanoma in 8 participants. Terminated before completion.
| Lead sponsor | Inge Marie Svane |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 17 September 2021 |
| Primary completion | 7 June 2024 |
| Estimated completion | 7 June 2024 |
| Sites | 1 location across Denmark |
Inge Marie Svane — full company profile →
Adults 18 to 75, any sex, with Malignant Melanoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of patients experiencing grade III or worse adverse events. The grading of adverse events was performed according to CTCAE ver. 5.0.
| Group | Value | 95% CI |
|---|---|---|
| Part A | 6 | |
| Part B | 0 |
Number of patients excluded due to treatment related feasibility issues compared to the number of patients enrolled in the study.
| Group | Value | 95% CI |
|---|---|---|
| Part A | 1 |
Number of patients excluded due to treatment related safety issues compared to the number of patients enrolled in the study.
| Group | Value | 95% CI |
|---|---|---|
| Part A | 0 |
Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) assessed by CT scan. Complete Response (CR): Disappearance of all target lesions Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions Progressive disease: \>= 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 Stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
| Group | Value | 95% CI |
|---|---|---|
| Part A | 3 | |
| Part A | 3 |
Time frame: The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Part A | Part B |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Fatique | General disorders | — | — |
| Lymphopenia | Immune system disorders | — | — |
| Neutropenia | Immune system disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Dry mouth | General disorders | — | — |
| Pain | General disorders | — | — |
| Trombocytopenia | Blood and lymphatic system disorders | — | — |
| Dizziness and palor | General disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Fever | General disorders | — | — |
| Hyponatriemia | Metabolism and nutrition disorders | — | — |
| Increase in CRP | General disorders | — | — |
| Loss of appetite | Gastrointestinal disorders | — | — |
| Obstipation | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
Data from ClinicalTrials.gov NCT04904185 adverse events section.
With the introduction of checkpoint inhibitors substantial improvements have been made in the treatment of malignant melanoma (MM). Despite this still a a subset of patients, approximately 50 %, experience no response to therapy. One of the strategies to overcome these obstacles have been ACT with tumour infiltrating lymphocytes (TILs). Most TIL based ACT products are non-specifically expanded providing growth preference to co-infiltrated virus specific T cells, and it is currently challenging to expand T cells in an antigen-specific manner, while at the same time obtaining the ideal functional characteristics for specific and strong tumour-killing capacity with sufficient persistence. In this phase I trial artificial antigen-presenting scaffolds for antigen-driven T cell expansion are used. These scaffolds will generate a MASE-T cell product enriched for selected specificities towards antigens known to be expressed by melanoma cells The aim of the study is to demonstrate that treatment with af MASE-T cell product i safe and feasible. Further the study will elucidate whether treament with the MASE-T cell product leads to objective responses and improves progression free survival (PFS).
4 peer-reviewed publications reference this trial (live from Europe PMC):
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