Tabelecleucel for Primary Immunodeficiency-Associated Lymphoproliferative Disease (PID-LPD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Primary Immunodeficiency-Associated Lymphoproliferative Disease (PID-LPD)+13 MoreTabelecleucel - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new treatment for diseases caused by the Epstein-Barr virus.

Eligible Conditions
  • Primary Immunodeficiency-Associated Lymphoproliferative Disease (PID-LPD)
  • Leiomyosarcoma
  • Epstein-Barr Virus-associated Sarcomas
  • Epstein-Barr Virus (EBV) Associated Diseases
  • Epstein-Barr Virus Associated Post-transplant Lymphoproliferative Disease
  • Allogeneic Bone Marrow Transplant
  • Hemophagocytic Lymphohistiocytosis
  • Stem Cell Transplant Complications
  • CNS Posttransplant Lymphoproliferative Disease (PTLD)
  • Chronic Active Epstein-Barr Virus With Hemophagocytic Lymphohistiocytosis (HLH)
  • Lymphoproliferative Disorders
  • Acquired Immunodeficiency-Associated Lymphoproliferative Disease (AID LPD)
  • Chronic Active Epstein-Barr Virus
  • Solid Organ Transplant Rejection

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Duration of response (DOR)
For EBV+ PID LPD and CAEBV/HLH cohorts who are eligible for allogeneic HCT: Number of participants who reach definitive therapy (ie, allogeneic HCT) for the underlying disease
For EBV+ PID LPD and CAEBV/HLH cohorts who are eligible for allogeneic HCT: Time to allogeneic HCT
For EBV+ sarcomas, including LMS: Clinical benefit rate
For EBV+ sarcomas, including LMS: ORR by immune response evaluation criteria in solid tumors (iRECIST) criteria
Objective response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

6 Treatment Groups

EBV+ PTLD CNS
1 of 6
CAEBV/ HLH
1 of 6
EBV+ PTLD (ineligible for first-line therapy or CD20 negative)
1 of 6
EBV+ AID LPD
1 of 6
EBV+ PID LPD
1 of 6
EBV+ sarcoma, including LMS
1 of 6

Experimental Treatment

228 Total Participants · 6 Treatment Groups

Primary Treatment: Tabelecleucel · No Placebo Group · Phase 2

EBV+ PTLD CNS
Biological
Experimental Group · 1 Intervention: Tabelecleucel · Intervention Types: Biological
CAEBV/ HLH
Biological
Experimental Group · 1 Intervention: Tabelecleucel · Intervention Types: Biological
EBV+ PTLD (ineligible for first-line therapy or CD20 negative)
Biological
Experimental Group · 1 Intervention: Tabelecleucel · Intervention Types: Biological
EBV+ AID LPD
Biological
Experimental Group · 1 Intervention: Tabelecleucel · Intervention Types: Biological
EBV+ PID LPD
Biological
Experimental Group · 1 Intervention: Tabelecleucel · Intervention Types: Biological
EBV+ sarcoma, including LMS
Biological
Experimental Group · 1 Intervention: Tabelecleucel · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Atara BiotherapeuticsLead Sponsor
11 Previous Clinical Trials
475 Total Patients Enrolled
Justin Wahlstrom, MDStudy DirectorAtara Biotherapeutics
2 Previous Clinical Trials
252 Total Patients Enrolled
Dr. Faith Galderisi, DOStudy DirectorAtara Biotherapeutics

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Eastern Cooperative Oncology Group performance status <= 3 for participants aged >= 16 years; Lansky score >= 20 for participants from 1 year to < 16 years, except for those with neuroblastoma.
should not be treated with standard first-line therapy
Individuals diagnosed with newly diagnosed or relapsed/refractory lymphoma with Epstein-Barr virus (EBV) associated disease, or with positive cerebrospinal fluid (CSF) cytology with or without radiographically measurable intracranial disease with EBV detected in CSF will have adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator.
at study entry People taking part in this study must have a disease that can be measured systemically, as well as in the central nervous system.
by PCR Participants diagnosed with EBV+ LPD should not be eligible for standard first-line therapy, as determined by the investigator
by PCR People who have recently been diagnosed with LPD should not be eligible for first-line therapy as determined by the investigator.
and The patient must meet two criteria in order to be eligible for tabelecleucel therapy

Who else is applying?

What state do they live in?
Michigan100.0%
How old are they?
65+100.0%
What site did they apply to?
Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics)100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%