Trial · NCT02065869

Safety Study of Gene Modified Donor T-cells Following TCRαβ+ Depleted Stem Cell Transplant

NCT02065869, Phase 1, Phase 2, Terminated, Bellicum Pharmaceuticals; results first posted 2023-01-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety Study of Gene Modified Donor T-cells Following TCRαβ+ Depleted Stem Cell Transplant. Trials, record NCT02065869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02065869

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety Study of Gene Modified Donor T-cells Following TCRαβ+ Depleted Stem Cell Transplant
NCT number: NCT02065869
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 187 participants, actual
Lead sponsor: Bellicum Pharmaceuticals
Conditions: Acute Lymphoblastic Leukemia, Leukemia, Acute Myeloid (AML), Child, Lymphoma, Non-Hodgkin, Myelodysplastic Syndrome, Primary Immunodeficiency, Anemia, Aplastic, Osteopetrosis, Hemoglobinopathies, Cytopenia, Fanconi Anemia, Diamond Blackfan Anemia, Thalassemia, Anemia, Sickle Cell
Interventions: BPX-501 T cells, Rimiducid
First posted: 2014-02-19
Last updated: 2023-09-29
Results first posted: 2023-01-04

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Event-free Survival (EFS) at 180 Days After Transplant	180 days after transplant	Events included transplant-related mortality (TRM) / non-relapse mortality (NRM), severe GvHD (acute Grades 2-4 organ or extensive chronic GvHD) and life-threatening infections (Grade 4). Time to the first event only is represented in the primary endpoint, if a subsequent event occurred in the same patient this was not captured in this outcome. There were no protocol-specified primary endpoints for Phase I of the study.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event-free Survival (EFS) at 180 Days After Transplant	180 days after transplant	ITT population: All patients treated with HSCT who received 1×10\^6 cells/kg BPX-501	Event-Free Survival Estimate (%)	NUMBER

Source ClinicalTrials.gov

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Event-free Survival (EFS) at 180 Days After Transplant	BPX-501 T Cells and Rimiducid		90.8	95% Confidence Interval 84.6 to 94.5	Event-Free Survival Estimate (%)

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	BPX-501 T Cells and Rimiducid	184
Overall Study	Patients Receiving Rivogenlecleucel (BPX-501 Safety Population)	BPX-501 T Cells and Rimiducid	171
Overall Study	ITT Population	BPX-501 T Cells and Rimiducid	142
Overall Study	Patients Receiving at Least 1 Dose of Rimiducid	BPX-501 T Cells and Rimiducid	16
Overall Study	COMPLETED	BPX-501 T Cells and Rimiducid	149
Overall Study	NOT COMPLETED	BPX-501 T Cells and Rimiducid	35

Source ClinicalTrials.gov

Adverse events158

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cytomegalovirus infection	Infections and infestations	BPX-501	34	171
other	Cytomegalovirus infection	Infections and infestations	Rimiducid	0	16
other	Adenovirus infection	Infections and infestations	BPX-501	11	171
other	Adenovirus infection	Infections and infestations	Rimiducid	0	16
other	Human herpesvirus 6 infection	Infections and infestations	BPX-501	9	171
other	Human herpesvirus 6 infection	Infections and infestations	Rimiducid	0	16
other	Acute graft versus host disease	Infections and infestations	BPX-501	48	171
other	Acute graft versus host disease	Infections and infestations	Rimiducid	3	16
other	Rash	Skin and subcutaneous tissue disorders	BPX-501	21	171
other	Rash	Skin and subcutaneous tissue disorders	Rimiducid	0	16

1 to 10 of 158Source ClinicalTrials.gov

See all 158 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BPX-501	7	171
Total, all-cause mortality	Rimiducid	0	16
Total, other adverse events	BPX-501	140	171
Total, other adverse events	Rimiducid	9	16
Total, serious adverse events	BPX-501	52	171
Total, serious adverse events	Rimiducid	7	16

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
BPX-501 vs Rimiducid: deaths from any cause	Trial comparisons
BPX-501 vs Rimiducid: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02065869

GET https://conductscience.org/api/trials/v1/NCT02065869/events?page=2

API reference For AI assistants