Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06090864 · ClinicalTrials.gov registry record · Phase 1
ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells
A Phase 1 study of Hodgkin Lymphoma and Relapse, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT06090864: Recruiting Phase 1 study of Hodgkin Lymphoma and Relapse, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT06090864 is a Phase 1 study of Hodgkin Lymphoma and Relapse that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 31 participants, below the 165-participant average among 71 other Hodgkin Lymphoma trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06090864, a Phase 1 study of Hodgkin Lymphoma and Relapse, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting. New therapeutic agents are required therefore not only to further reduce mortality but also to alleviate morbidity. The majority of HL express the CD30 antigens. CD30 expression is routinely used for the diagnosis of HL. Preclinical observations support CD30 as a viable target of CAR-T therapy. This phase Ib/II study was conducted based on these observations. The purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in subjects with Hodgkin's Lymphoma and identify a recommended dose for further. This is a single-center, open-label phase Ib/II trial that uses a 3+3 design to identify a recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin's Lymphoma. The phase II portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin's Lymphoma. Subjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25 evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells, Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion 2-14 days later. Subjects will then be followed for 15 years as is required for studies involving gene transfer experiments.
Primary Outcome
Toxicity will be graded as the number of participants with adverse events (AE) related to the administration of ATLCAR.CD30.CCR4 cells in subjects with CD30+ Hodgkin's Lymphoma. AEs will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Dose Limiting Toxicities (DLTs) are defined as at least possibly related to CAR.B7-H3T cell product administration.
Conditions Studied
Interventions
- DRUG Chemotherapy
- BIOLOGICAL Cell infusion
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2024-04-25 |
| Est. Completion | 2031-07-01 |
| Phase | Phase 1 |
What NCT06090864 shows while recruiting
NCT06090864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 165-participant average among 71 other Hodgkin Lymphoma trials with a reported enrollment target (81% lower).
The record links to 3 conditions, with Hodgkin Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Chemotherapy is the first listed.
NCT06090864 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06090864 about?
NCT06090864 is a clinical study titled "ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells". Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting. New therapeutic agents are required therefore not only to further reduce mortality but also to alleviate...
What is the current status of trial NCT06090864?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2024-04-25. Estimated completion is 2031-07-01.
What conditions does trial NCT06090864 study?
This clinical trial studies the following conditions: Hodgkin Lymphoma, Relapse, Refractory.
What interventions are being tested in trial NCT06090864?
The interventions under investigation include: Chemotherapy (DRUG), Cell infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT06090864?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06090864 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hodgkin Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06090864's enrollment target sits among peer trials
31 49th of 71 higher than 23 of 71 other Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hodgkin Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
RECRUITING · Phase 1
-
Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies
RECRUITING · Phase 1
-
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
RECRUITING · Phase 1
-
AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.
RECRUITING · Phase 1
-
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
RECRUITING · Phase 1
-
Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI