New cellular therapy for Hodgkin Lymphoma
The Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) and CCR4 for Relapsed/Refractory CD30+ Hodgkin s Lymphoma
This study is testing a new type of cell therapy for people with relapsed or hard-to-treat Hodgkin Lymphoma to see if it is safe and effective.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, CAR-T |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06090864 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of ATLCAR.CD30.CCR4 cells in patients with Hodgkin Lymphoma that is relapsed or refractory. It is a single-center, open-label study that aims to determine the tolerability of this novel cellular therapy and establish a recommended dose for further investigation. The trial employs a 3+3 design to identify the optimal dose and includes a phase II component to assess progression-free survival in participants. Patients may receive standard-of-care therapies during the study to stabilize their condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory Hodgkin Lymphoma expressing CD30 antigens.
Not a fit: Patients with non-CD30 expressing Hodgkin Lymphoma or those who are not eligible for lymphodepletion may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve outcomes for patients with Hodgkin Lymphoma who have limited treatment options.
How similar studies have performed: Other studies targeting CD30 in Hodgkin Lymphoma have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chapel Hill, North Carolina
- Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Natalie Grover, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Catherine Cheng
- Email: UNCImmunotherapy@med.unc.edu
- Phone: +1 919-445-4208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.