Hodgkin Lymphoma, Lymphoma, Large B-Cell, Diffuse, Post-transplant Lymphoproliferative Disorder
Conditions
Keywords
Epstein-Barr Virus, DLBCL, PTLD, EBV, CIVIC, HL, T cell
Brief summary
To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
Interventions
BIOLOGICALbaltaleucel-T
Autologous EBV-specific T cells
Sponsors
Cell Medica Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The study will include three primary cohorts, with any of the following EBV+ diseases: Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous transplantation following salvage therapy OR 2) relapse following autologous transplantation. Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV. Cohort C - PTLD, rituximab treatment failure. 2. Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months. 3. Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory. 4. Absolute lymphocyte count (ALC) \>500/µL 5. Male or female ≥ 12 years of age 6. Weight ≥ 35 kg 7. Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky score ≥ 60, as age appropriate 8. Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients.
Exclusion criteria
1. Known central nervous system (CNS) lymphoma 2. Primary refractory HL or DLBCL 3. Bulky disease 4. Relapse or progression following previous autologous EBV specific T cell treatment. 5. Use of systemic corticosteroids \> 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 mL starting material 6. Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus (HTLV). 7. Patient is pregnant or lactating 8. Systemic fungal, bacterial, viral or other infection that is not controlled 9. Prior allogeneic hematopoietic stem cell transplantation (allo HSCT) 10. Known history of primary immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response | 1 year | Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 year | Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration. |
Countries
United States
Participant flow
Recruitment details
Study was closed early due to inadequate recruitment.
Participants by arm
| Arm | Count |
|---|---|
| Baltaleucel-T Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.
baltaleucel-T: Autologous EBV-specific T cells | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Baltaleucel-T |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Cohort B - Hodgkin Lymphoma (HL) | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 1 / 1 |
Outcome results
Primary
Best Overall Response
Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.
Time frame: 1 year
Population: Subject was withdrawn early before first disease assessment timepoint.
Secondary
Adverse Events
Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Balteleucel-T | Adverse Events | 1 Participants |