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Trial Title:
ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells
NCT ID:
NCT06090864
Condition:
Hodgkin Lymphoma
Relapse
Refractory
Conditions: Official terms:
Lymphoma
Conditions: Keywords:
cellular therapy
CD30+
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
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.
Arm group label:
ATLCAR.CD30
Intervention type:
Biological
Intervention name:
Cell infusion
Description:
ATLCAR.CD30.CCR4 cells infusion for the eligible subjects after depletion chemotherapy.
Arm group label:
ATLCAR.CD30
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Natalie Grover, MD
Phone:
919-966-4431
Email:
UNCImmunotherapy@med.unc.edu
Contact backup:
Last name:
Catherine Cheng
Phone:
+1 919-445-4208
Email:
UNCImmunotherapy@med.unc.edu
Start date:
April 25, 2024
Completion date:
July 1, 2031
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06090864
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
