Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-75
SponsorBaylor College of Medicine
About this trial
This study involved patients that have a cancer called diffuse large B cell lymphoma (DLBCL), NK and T cell lymphomas (NK/TL) or classical Hodgkin lymphoma (cHL) (hereafter these 3 diseases will be referred to as lymphoma). Patients lymphoma has come back or not gone away after treatment. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, the patients are being asked to volunteer in this research study.
In this study the investigators want to test a type of T cell made from a normal donor. The T cells the investigators will use are called Epstein Barr virus (EBV) specific T cells (EBVSTs) and are cells that the investigators have trained in the laboratory to recognize a EBV which is the virus that causes mono or kissing disease. Some patients with lymphoma have EBV in their cancer cells. Researchers have given T cell lines from normal donor EBVSTs to lymphoma patients who have EBV in their lymphoma cells and have seen responses in about half the patients. The cells have have been generated and are frozen in a bank. The cells are called "allogeneic" (meaning the donor is not related to the patient). CD30.CAR in EBV-specific T cells (called allogeneic CD30.CAR-EBVST) from the blood of healthy donors. The investigators are giving the cells to patients with lymphoma cells that express CD30. If the lymphoma cells also express EBV there may be some benefit from targeting both proteins.
The purpose of this study is to find out the highest safe dose of allogeneic CD30.CAR-EBVST cells given following chemotherapy and used to treat lymphoma. The investigators will learn the side effects of CD30.CAR-EBVST cells in patients and see whether this therapy may help lymphoma patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hodgkin lymphoma
Aggressive non-Hodgkin lymphoma
ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma
ALK-positive anaplastic T cell lymphoma
Disqualifiers
Received an investigational cell therapy or vaccine within the past 6 weeks.
Received an investigational small molecule drug within the past 2 weeks.
Received CD30 antibody-based therapy within the previous 4 weeks.
Received gemcitabine-containing chemotherapy within the previous 12 weeks
Trial design
Design model
Single group
Treatments tested in this trial
CD30.CAR-EBVST cells
Biological/VaccineThe dose is based on the number of CD30.CAR-expressing cells. In our previous study the highest dose was 2 × 10\^8 cells/m2 and we did not reach an MTD. This will be administered as a single infusion of the full dose for each level, which was already shown to be safe in the first 3 patients treated at dose level 3. Since we have not observed any dose limiting toxicities at the current dose level (Dose Level 3 as of June 2022), we propose to include a new higher dose level (8 × 10\^8).There will be a gap of 4 weeks between the first and second patient, and between the second and the third patient, on each dose level.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Treatment PhaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose limiting toxicity rate (DLT) by CTCAE 5.0
Any Grade 5 event, / Non-hematologic dose-limiting toxicity is any Grade 3 or Grade 4 non-hematologic toxicity that affects the cardiopulmonary system, or corresponds to neurotoxicity, or otherwise fails to return to Grade 2 within 72 hours, / Grade 2-4 allergic reaction to T-Cells, / Grade 3-4 GVHD, / Hematologic dose limiting toxicity is defined as any Grade 4 hematologic toxicity that fails to return to Grade 2 or baseline (whichever is more severe) within 14 days or within 28 days for patients with evidence of bone marrow disease.
Time frame
28 daysSecondary outcomes
1
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 infusion2
Duration of response
Response duration will be measured from the time of initial response until documented tumor progression.
Time frame
Up to 5 years3
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 infusion4
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 yearsSponsors and contacts
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Baylor College of Medicine
Lead sponsor
The Methodist Hospital Research Institute
Collaborator
Source ClinicalTrials.gov