Trial Outcomes & Findings for Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas (NCT NCT02763254)

NCT ID: NCT02763254

Last Updated: 2019-03-26

Results Overview

Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2019-03-26

Participant Flow

Study was closed early due to inadequate recruitment.

Participant milestones

Measure	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
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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
Overall Study Adverse Event	1

Baseline Characteristics

Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas

Baseline characteristics by cohort

Measure	Baltaleucel-T n=1 Participants Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. baltaleucel-T: Autologous EBV-specific T cells
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants
Cohort B - Hodgkin Lymphoma (HL)	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Subject was withdrawn early before first disease assessment timepoint.

Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Balteleucel-T n=1 Participants Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. balteleucel-T: Autologous EBV-specific T cells
Adverse Events	1 Participants

Adverse Events

Baltaleucel-T

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	Baltaleucel-T n=1 participants at risk Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. baltaleucel-T: Autologous EBV-specific T cells
Immune system disorders Cytokine Release Syndrome	100.0% 1/1 • Number of events 1 • 1 month Prescheduled hospital admissions, hospital admissions for elective surgery, transfusions, diagnostic procedures are not considered to be SAEs. Events related to progression of the underlying malignancy will likewise not be categorized as serious.
Blood and lymphatic system disorders Hemophagocytic Lymphohistiosytosis	100.0% 1/1 • Number of events 1 • 1 month Prescheduled hospital admissions, hospital admissions for elective surgery, transfusions, diagnostic procedures are not considered to be SAEs. Events related to progression of the underlying malignancy will likewise not be categorized as serious.

Other adverse events

Measure	Baltaleucel-T n=1 participants at risk Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. baltaleucel-T: Autologous EBV-specific T cells
General disorders Fatigue	100.0% 1/1 • Number of events 1 • 1 month Prescheduled hospital admissions, hospital admissions for elective surgery, transfusions, diagnostic procedures are not considered to be SAEs. Events related to progression of the underlying malignancy will likewise not be categorized as serious.
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 2 • 1 month Prescheduled hospital admissions, hospital admissions for elective surgery, transfusions, diagnostic procedures are not considered to be SAEs. Events related to progression of the underlying malignancy will likewise not be categorized as serious.
Investigations Platelet Count Decreased	100.0% 1/1 • Number of events 1 • 1 month Prescheduled hospital admissions, hospital admissions for elective surgery, transfusions, diagnostic procedures are not considered to be SAEs. Events related to progression of the underlying malignancy will likewise not be categorized as serious.

Additional Information

Dr. Kurt Gunter (Chief Medical Officer)

Cell Medica

Phone: 832-581-4480

Email: Kurt.Gunter@cellmedica.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60