Recruiting
Phase 1
Phase 2

ATLCAR.CD30.CCR4

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06090864

Conditions

Hodgkin Lymphoma

Relapse

Refractory

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chemotherapy

Cell infusion

Study Details

Brief 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.

Conditions

Hodgkin Lymphoma

Relapse

Refractory

Study ID

NCT06090864

Start date

Apr 25, 2024

Status verified date

Aug, 2026

Completion date

Jul 1, 2033

Anticipated

Primary completion date

Aug 3, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

During the period of cell procurement and lymphodepletion, subjects will be eligible to receive standard-of-care therapy e.g., chemotherapy or radiation therapy to stabilize their disease if the treating physician feels it is in the subject's best interests. Eligibility must be maintained up until the subject is procured, receives lymphodepletion, or receives treatment for the subject to be considered eligible to proceed with the specific phase of the study.

Inclusion Criteria:

Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study. As these criteria are unchanging they will be evaluated at the time of initial enrollment and not continuously throughout the study.

1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by, and signed by the subject or legally authorized representative.
2. Age ≥ 18 years at the time of consent.
3. Karnofsky score of > 60%
4. The subject must have a diagnosis of Classical Hodgkin Lymphoma according to World Health Organization criteria.

Exclusion Criteria:

1. Subjects had major surgery within 28 days.
2. Subject received investigational agents or tumor vaccines within 3 weeks.
3. Subject received chemotherapy or radiation therapy within the previous 3 weeks.

Study Design

Enrollment

31 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ATLCAR.CD30

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

Interventions

Chemotherapy

Subjects will receive a lymphodepletion regimen of bendamustine 70 mg/m2 IV and fludarabine 30 mg/m2 each as a daily infusion for 3 consecutive days prior to the ATLCAR.CD30.CCR4 cell infusion.

Cell infusion

ATLCAR.CD30.CCR4 cells infusion for the eligible subjects after depletion chemotherapy.

Primary outcome measure

  • Phase 1b adverse events [ Time Frame: Up to 6 weeks ]
  • Phase 1b Toxicity Cytokine Release Syndrome (CRS) [ Time Frame: Up to 6 weeks ]
  • Phase 1b Toxicity Immune effector cell-associated neurotoxicity syndrome (ICANS) [ Time Frame: Up to 6 weeks ]
  • Phase II Median Progression Free Survival (PFS) [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Catherine Cheng

+1 919-445-4208UNCImmunotherapy@med.unc.edu

Locations

Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Natalie Grover, MD

919-966-4431UNCImmunotherapy@med.unc.edu

Catherine Cheng

+1 919-445-4208UNCImmunotherapy@med.unc.edu

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • cellular therapy
  • CD30+

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-08-06.