Clinical trial · Observational
Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product
Long-Term Follow-Up Study of Subjects Treated With an Autologous T Cell Product Expressing an Antibody-Coupled T-Cell Receptor (ACTR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Decision
Summary
Brief summary (as posted)
Subjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. No investigational product or treatment will be administered in this study. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B Cell Lymphomas | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| HER-2 Protein Overexpression | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACTR T Cell Product | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Post-ACTR
- description
- Subjects who have previously been treated with an ACTR T cell product
- interventionNames
- Other: ACTR T Cell Product
Primary outcomes (5)
- measure
- Long-term safety of ACTR T cell product as assessed by overall survival
- timeFrame
- Total of 15 years after first receiving an ACTR T cell product
- measure
- Long-term safety of ACTR T cell product as assessed by serious adverse events related to ACTR T cell product
- timeFrame
- Total of 15 years after first receiving an ACTR T cell product
- measure
- Long-term safety of ACTR T cell product as assessed by Grade 3 or 4 adverse events related to ACTR T cell product
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Willing to provide informed consent for participation in the study * Received at least 1 dose of an ACTR T cell product in an investigational or other treatment setting, such as compassionate use, named patient IND, expanded access program, or equivalent settings * Has completed study assessments and follow-up visits in the prior study or other investigational setting to the extent willing and able to do so * Able to comply with study requirements Exclusion Criteria * None
References
Publications (0)
Data not yet available