NCT05194735 · OUTCOME
Feasibility of TCR-T Cell Drug Product Manufacturing
Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors · Source last updated 2025-11-10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From apheresis collection to the release of the final TCR-T cell drug product for infusion, estimated to be approximately 5 weeks
What was measured
Feasibility will be assessed by the number of participants who met eligibility criteria at each step of the manufacturing process, including inability to undergo apheresis, failure of product manufacture, manufactured product not infused, and successful manufacture and infusion of TCR-T cell drug product.
Analysis population: The feasibility analysis included 14 participants who underwent apheresis with intent to manufacture TCR-T cell product. Although only 8 met criteria for lymphodepletion and were considered formally enrolled per protocol, all 14 apheresed participants were included for feasibility assessment because manufacturing could be attempted for each.
Groups in this outcome
Apheresed Participants (Feasibility Population)
Includes all 14 participants who underwent apheresis with intent to manufacture TCR-T cell drug product. Although only 8 met criteria for lymphodepletion and were considered enrolled per protocol, all 14 were included for assessment of manufacturing feasibility.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Apheresed Participants (Feasibility Population) | 14 |
|---|
Reported measurements
Unable to be apheresed for logistical or medical reasons
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Apheresed Participants (Feasibility Population) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Apheresis performed but manufacturing not initiated due to study closure
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Apheresed Participants (Feasibility Population) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Product was successfully manufactured but not administered due to progression or comorbidity.
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Apheresed Participants (Feasibility Population) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Infused successfully at the planned dose after 1 manufacturing round.
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Apheresed Participants (Feasibility Population) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Infused at a lower dose than planned after 1 manufacturing round.
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Apheresed Participants (Feasibility Population) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Infused at a lower dose than planned after 2 manufacturing rounds.
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Apheresed Participants (Feasibility Population) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Patients who were manufacturing failures after 2 manufacturing rounds.
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Apheresed Participants (Feasibility Population) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Product was successfully manufactured but not administered due to study closure.
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Apheresed Participants (Feasibility Population) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Unable to be apheresed for logistical or medical reasons
- title
- Apheresis performed but manufacturing not initiated due to study closure
- title
- Product was successfully manufactured but not administered due to progression or comorbidity.
- title
- Infused successfully at the planned dose after 1 manufacturing round.
- title
- Infused at a lower dose than planned after 1 manufacturing round.
- title
- Infused at a lower dose than planned after 2 manufacturing rounds.
- title
- Patients who were manufacturing failures after 2 manufacturing rounds.
- title
- Product was successfully manufactured but not administered due to study closure.
- description
- Feasibility will be assessed by the number of participants who met eligibility criteria at each step of the manufacturing process, including inability to undergo apheresis, failure of product manufacture, manufactured product not infused, and successful manufacture and infusion of TCR-T cell drug product.
- groups
- description
- Includes all 14 participants who underwent apheresis with intent to manufacture TCR-T cell drug product. Although only 8 met criteria for lymphodepletion and were considered enrolled per protocol, all 14 were included for assessment of manufacturing feasibility.
- id
- OG000
- title
- Apheresed Participants (Feasibility Population)
- param Type
- NUMBER
- population Description
- The feasibility analysis included 14 participants who underwent apheresis with intent to manufacture TCR-T cell product. Although only 8 met criteria for lymphodepletion and were considered formally enrolled per protocol, all 14 apheresed participants were included for feasibility assessment because manufacturing could be attempted for each.
- reporting Status
- POSTED
- time Frame
- From apheresis collection to the release of the final TCR-T cell drug product for infusion, estimated to be approximately 5 weeks
- title
- Feasibility of TCR-T Cell Drug Product Manufacturing
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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