Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT04288726
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Classical Hodgkin Lymphoma
  • Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CD30.CAR-EBVST cells — BIOLOGICAL
    The 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.

Study Details

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

Key Dates

Start date
Sep 16, 2020
Status verified
Jun 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2037

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Phase
    Four dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells. Cohorts of three to six 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 CD30.CAR-EBVST cells * Dose Level 2: 1 × 10\^8 CD30.CAR-EBVST cells * Dose Level 3: 4 × 10\^8 CD30.CAR-EBVST cells * Dose Level 4: 8 × 10\^8 CD30.CAR-EBVST cells

Primary Outcome Measure

Dose limiting toxicity rate (DLT) by CTCAE 5.0 [ Time Frame: 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030
Carlos Ramos, MD
[email protected]
(713) 441-1450
Texas Children's HospitalHoustonTexas77030
Carlos Ramos, MD
[email protected]
(713) 441-1450

Find similar trials in Houston, TX

By research site
Houston Methodist Hospital· Houston, TXTexas Children's Hospital· Houston, TX

Related Studies