Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT02487459|
Recruitment Status : Withdrawn
First Posted : July 1, 2015
Last Update Posted : October 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Biological: BPX-501 Drug: AP1903||Phase 1|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
The objective is to evaluate the safety of two planned infusions of BPX-501 after partially mismatched, related HSCT with post-transplant cyclophosphamide and to evaluate the safety and efficacy of the treatment of dimerizer drug, rimiducid (AP1903), to subjects who received BPX-501 and have uncontrolled GvHD. Assuming no toxicity, enrollment will proceed sequentially for the initial 9 patients (following the 3+3 design), who will be followed for 100 days, prior to enrolling the subsequent 31 patients. Toxicity may increase the number of initial group of patients). As multiple dose levels may be administered among the first 9 (or more) patients, toxicity will be assessed on the cohort with the maximum tolerated dose (MTD).
The Medical Monitoring committee will review the data with the investigators and determine whether to proceed and or implement any changes to the protocol
BPX-501 contains genetically modified donor T cells that have an inducible safety switch iCasp9 suicide gene. In the event of acute GvHD, administration of rimiducid dimerizes and activates caspase 9; this activates downstream caspases, obligating cellular apoptosis within 24 hours.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Safety Study of Planned BPX-501 T Cell Infusion After Partially Mismatched, Related, HSCT in Adults With Advanced Hematologic Malignances at High Risk for Relapse|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: BPX-501 and AP1903
Three cohorts, 3 patients each, will receive two infusions (at the same dose) of BPX-501.
If needed to treat aGVHD, a single dose of AP1903 will be administered IV.
T cells transduced with CaspaCIDe suicide gene
dimerizer drug administered to treat GVHD
Other Name: Rimiducid
- Adverse events [ Time Frame: 2 years ]Number of adverse events after BPX-501 as a measure of safety
- Adverse events [ Time Frame: 48 hours ]Number of adverse events after AP1903 as a measure of safety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487459
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Director:||Bellicum Pharmaceuticals||Bellicum Pharmaceuticals, Inc.|