A Phase 1 interventional study of C7R.CD30.CAR-EBVST cells in CD30-Positive Diffuse Large B-Cell Lymphoma, Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type and Anaplastic Large Cell Lymphoma, ALK-Positive, sponsored by Baylor College of Medicine. Recruiting at 2 sites in United States. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Baylor College of Medicine · Phase 1, Interventional, and Treatment
This study involves patients with diffuse large B cell lymphoma (DLBCL), natural killer/T-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma) whose disease has returned or not responded to treatment.
Previous research combined antibodies and T cells to treat cancer. Antibodies bind to foreign substances, and T cells are infection-fighting white blood cells that can kill tumor cells. Both approaches have shown promise but have not been sufficient to cure most patients. In prior studies, an antibody targeting CD30, a protein found on some T cells and cancer cells, was joined to T cells through gene transfer to create CD30.CAR T cells.
Another study showed encouraging responses using CD30.CAR T cells made from a patient's own blood and returned to the same patient (autologous cells). In an ongoing study, patients have been treated with CD30.CAR T cells derived from healthy donors (allogeneic cells), allowing use of banked cells without individualized manufacturing. This approach has shown promising clinical activity with no safety concerns to date.
In this study, investigators are evaluating CD30.CAR-EBVST cells modified with an additional molecule called C7R, which has been shown in laboratory studies to enhance anti-cancer effects. The study aims to assess the safety and effectiveness of these allogeneic, banked C7R-modified CD30.CAR-EBVST cells and determine whether they may help treat lymphoma.
As an added safety measure, the modified T cells include a marker called iC9. If significant side effects occur, patients may receive rimiducid, which can eliminate the infused T cells. Rimiducid is not yet FDA approved but has been tested in patients without significant side effects.
This is a Phase 1 dose-escalation study evaluating allogeneic C7R.CD30.CAR-EBVST cells in patients with relapsed or refractory CD30-positive lymphoma.
Participants are treated in sequential cohorts at one of four dose levels of C7R.CD30.CAR-EBVST cells. Treatment begins at the lowest dose level, and subsequent cohorts are treated at higher dose levels if the preceding dose is determined to be safe. If significant toxicity is observed, dose escalation may be halted, reduced, or discontinued. The relationship between dose level and both safety and potential clinical benefit is evaluated.
Prior to treatment, participants undergo screening evaluations including laboratory testing, imaging studies, and confirmation of CD30 expression. Human leukocyte antigen (HLA) testing is performed to identify the most appropriate partially matched cell line from a bank of allogeneic C7R.CD30.CAR-EBVST products.
Participants may receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine prior to infusion, as clinically appropriate, to reduce endogenous lymphocytes and support expansion of the infused cells.
C7R.CD30.CAR-EBVST cells are administered as a single intravenous infusion at the assigned dose level. Premedication may be given to reduce the risk of infusion-related reactions. Participants are monitored in the clinical setting following infusion and are required to remain within close proximity to the treatment center for a defined period to allow for monitoring of potential adverse events.
Following treatment, participants undergo scheduled follow-up evaluations including physical examinations, laboratory testing, and imaging studies to assess safety and disease status. Blood samples are collected at multiple time points after infusion to evaluate persistence of the infused cells. Tumor assessments are performed using imaging and, when clinically indicated, biopsy.
Participants demonstrating an objective clinical response following initial dosing may be considered for up to three (3) additional infusions of C7R.CD30.CAR-EBVST cells, at the discretion of the treating clinical team.
Participants are followed longitudinally after treatment, with more frequent assessments early after infusion and less frequent long-term follow-up, for up to 15 years after the most recent infusion.
219 studies on the registry are indexed under Lymphoma, Large-Cell, Anaplastic; 26 are open to participants now.
This study's planned enrollment of 90 is above the median of 41 across 188 interventional studies indexed under Lymphoma, Large-Cell, Anaplastic.
Browse Lymphoma, Large-Cell, Anaplastic studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
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Diagnosis and clinical course falling into one of the following categories:
Exclusion Criteria:
Four dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells. Cohorts of three patients will be enrolled at each dose level The dose is based on the number of CD.30 CAR-EBVT-expressing cells administered. The total number of dose levels evaluated will depend upon toxicities experienced. Dose level cohorts will be numbered sequentially. * Dose Level 1: 4 × 10\^7 C7R.CD30.CAR-EBVST cells * Dose Level 2: 1 × 10\^8 C7R.CD30.CAR-EBVST cells * Dose Level 3: 4 × 10\^8 C7R.CD30.CAR-EBVST cells * Dose Level 4: 8 × 10\^8 C7R.CD30.CAR-EBVST cells
Biological: C7R.CD30.CAR-EBVST cells
The dose is based on the number of CD30.CAR- expressing cells. In our previous study the highest dose was 4 × 10\^8 cells/m2 and we did not reach an MTD. On Day 0, patients will receive their planned dose of investigational T cell product by IV infusion over approximately 1 to 10 minutes in an expected volume of 1 to 50 mL.
Also known as: Allogeneic CR7.CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes
Dose Limiting Toxicity (DLT)
Dose-limiting toxicity (DLT) is defined as any of the following considered possibly, probably, or definitely related to study cellular products: (1) Grade 5 event without disease progression; (2) CRS: Grade 4, or Grade 3 not improving to ≤Grade 2 within 72 hours despite therapy; (3) ICANS: Grade 4, or Grade 3 not improving within 72 hours despite therapy; (4) Grade ≥3 IEC-HS; (5) Grade ≥3 acute GvHD requiring corticosteroids and not resolving within 7 days, or steroid-refractory Grade 2 GvHD; (6) Grade 4 neutropenia or thrombocytopenia not resolving to ≤Grade 2 within 42 days, or Grade 3 thrombocytopenia with major bleeding; (7) Grade ≥3 vital organ toxicity (except transient hepatic/renal abnormalities resolving within 7 days); (8) other Grade 3 toxicities not resolving within 72 hours; (9) Grade ≥2 allergic reaction.
Time frame: 28 days
Rate of Anti-Tumor effect Objective Response (OR)
Objective response rate is defined as complete response and partial response
Time frame: 6 to 8 weeks post CTL infusion
Duration of response
Response duration will be measured from the time of initial response until documented tumor progression.
Time frame: Up to 5 years
Stable disease (SD) rate
SD will be defined as the proportion of patients that have stable disease
Time frame: 6 to 8 weeks post CTL infusion
Duration of SD
Stable disease is measured from the start of the treatment until the criteria for progression are met.
Time frame: Up to 5 years
Progression free survival (PFS)
PFS is defined as the time from treatment until objective tumor progression or death, whichever occurs first.
Time frame: Up to 5 years
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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