Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02487459|
Recruitment Status : Not yet recruiting
First Posted : July 1, 2015
Last Update Posted : June 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Biological: BPX-501 Drug: AP1903||Phase 1|
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).
Stopping Rules (for the Phase II portion of the study):
- >20% of patients experience Grade III or IV acute GVHD attributable to BPX-501 T cells and non-responsive to AP1903 infusions.
- Grade IV reactions related to infusion of BPX-501 or AP1903.
- Death related to BPX-501 or AP1903 infusions.
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)|
|Estimated Enrollment :||40 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|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||December 2021|
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 40 mg 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
|Contact: Stefan O Ciurea, MDemail@example.com|
|United States, Texas|
|MD Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Stefan O Ciurea, MD||Associate Professor, Department of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center|