Trial · NCT07055477
A Phase I Trial Anti-CC Chemokine Receptor 4 Chimeric Antigen Receptor T Cells (CCR4 CAR T Cells) for CCR4 Expressing T-cell Malignancies Including Peripheral T-cell Non-Hodgkin Lymphoma (PTCL) and Cutaneous T-cell Non-Hodgkin Lymphoma (CTCL)
NCT07055477, Phase 1, Suspended, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I Trial Anti-CC Chemokine Receptor 4 Chimeric Antigen Receptor T Cells (CCR4 CAR T Cells) for CCR4 Expressing T-cell Malignancies Including Peripheral T-cell Non-Hodgkin Lymphoma (PTCL) and Cutaneous T-cell Non-Hodgkin Lymphoma (CTCL). Trials, record NCT07055477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07055477
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase I Trial Anti-CC Chemokine Receptor 4 Chimeric Antigen Receptor T Cells (CCR4 CAR T Cells) for CCR4 Expressing T-cell Malignancies Including Peripheral T-cell Non-Hodgkin Lymphoma (PTCL) and Cutaneous T-cell Non-Hodgkin Lymphoma (CTCL)
- NCT number
- NCT07055477
- Status
- Suspended
- Phases
- Phase 1
- Enrollment
- 60 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Relapsed and/or Refractory Mature T Cell Malignancy, Peripheral T-Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Hepatosplenic T-cell Lymphoma, Monomorphic Epithelialtropic Intestinal Lymphoma, Enteropathy Associated T-cell Lymphoma, Cutaneous T-Cell Lymphoma, Mycosis Fungoides, Subacute Panniculitis-like T-cell Lymphoma
- Interventions
- Cyclophosphamide, Fludarabine, Autologous CCR4 CAR T cells
- First posted
- 2025-07-09
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine safety profile of administering autologous CCR4 CAR T cells | 12 weeks | The number of participants who experience Adverse Events per CTCAE v5.0, by type, grade and frequency of toxicities from time of lymphodepleting regimen through 12 weeks after the last cell infusion. |
| Secondary | To determine the feasibility of manufacturing and delivering the targeted dose level of CCR4 CAR T cells to participants | 1 year | Feasibility will be defined by the successful manufacturing and expansion of the CCR4 CAR T cells for the first 6 participants to satisfy the targeted dose level and meet the requirements of the COA. |
| Secondary | Overall survival (OS) | After confirmed disease progression or initiation of new anti-cancer therapy, survival assessed every 3-6 months (+/- 28 days) up to 15 years. | OS will be assessed in each group and reported using the Kaplan-Meier method. |
| Secondary | Duration of response (DOR) and Progression-free survival (PFS) | weeks 4, 12, then every 3 months until Month 12, then at Months 18 and 24 then every 6 months until Month 60 then yearly, after cell infusion, until progression or up to 15 years post cell infusion. | DOR and PFS will be assessed with radiographic findings and reported using the Kaplan-Meier method. |
| Secondary | Complete response rate (CR), Partial response rate (PR) and Overall response rate (ORR=CR+PR) | Weeks 4, 12, then every 3 months until Month 12, then at Months 18 and 24 after cell infusion. | CR, PR and ORR will be assessed with radiographic findings and reported using the Kaplan-Meier method. |
| Secondary | Determine long-term safety profile of autologous CCR4 CAR T cells | Day 0 (cell infusion) up to 15 year after cell infusion | The long term safety will be assessed by the presence of RCL as well as clinical assessments. RCL samples at 3, 6 and 12 month post- cell infusion then yearly if needed. Once 3 consecutive samples are negative, RCL samples no longer need to be collected. Yearly medical history starting at 12 months to year 15. |
| Secondary | Dose Expansion: To determine preliminary efficacy of autologous CCR4 CAR T cells in a limited number of participants at the MTD by assessing the overall response rate (ORR=CR + PR) | Weeks 4, 12, then every 3 months until Month 12 after cell infusion. | ORR with radiographic findings in each group at baseline, and then best response at weeks 4, 12, then every 3 months until Month 12 after cells. |
| Secondary | Dose Escalation: To determine the maximum tolerated dose (MTD) of autologous CCR4 CAR T cells | 28 days from last cell infusion | The MTD will be determined by the dose found in the 3+3 design to cause design to cause \< 33% toxicityas defined by the DLT criteria. |
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/NCT07055477
GET https://conductscience.org/api/trials/v1/NCT07055477/registered