Trial · NCT06708455
Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 Melanoma
NCT06708455, Phase 2, Not yet recruiting, Rapa Therapeutics LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 Melanoma. Trials, record NCT06708455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06708455
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 Melanoma
- NCT number
- NCT06708455
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 65 participants, estimated
- Lead sponsor
- Rapa Therapeutics LLC
- Conditions
- Malignant Melanoma With Metastasis, Malignant Melanoma, Malignant Melanoma Stage IIIc, Malignant Melanoma Stage IV
- Interventions
- RAPA-201 Rapamycin Resistant T Cells, Chemotherapy Prior to RAPA-201 Therapy
- First posted
- 2024-11-27
- Last updated
- 2026-03-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of RAPA-201 Cell Therapy | 18 months (6 mo. of treatment; 12 mo of clinical follow-up) | In an intent-to-treat (ITT) manner, the efficacy of RAPA-201 cell therapy will be determined by overall response rate (ORR) in metastatic melanoma patients with progressive disease after anti-PD-(L)1 therapy, as assessed by the independent review committee (IRC) per iRECIST v1.1. |
| Secondary | Characterize RAPA-201 Efficacy | One (1) year after the last dose of RAPA-201 cells. | To further characterize RAPA-201 efficacy by measurement of duration of response (DOR; as measured in days), disease-control-rate (DCR; as measured in days ), progression-free-survival (PFS), and overall survival (OS; as measured in days), as assessed by the IRC and Site Investigator (iRECIST v1.1). |
| Secondary | Safety of RAPA-201 Cell Therapy | One (1) year after the last dose of RAPA-201 cells. | Safety, as measured by determination of the number and grade of any adverse event attributable to the RAPA-201 Investigational Product \[using the CTCAE v4.0 nomenclature\] |
| Secondary | Quality of Life (QOL) | One (1) year after the last dose of RAPA-201 cells. | To evaluate effect of therapy on quality of life (QOL) using the Short Form-36 Survey. The Short-Form 36 Survey that will be utilized uses a scale of 0-to-100, with higher scores indicating a better outcome. |
| Other | Immune Reconstitution | One (1) year after the last dose of RAPA-201 cells. | To characterize the immune reconstitution pattern in recipients of RAPA-201 therapy to better understand the therapeutic mechanism and lead to biomarker or predictive tests. Immune reconstitution will be quantified by determination of the absolute lymphocyte count (ALC) at the time of study entry, after RAPA-201 therapy, and then at the patient's last study visit. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06708455
GET https://conductscience.org/api/trials/v1/NCT06708455/registered