Study of Matched Unrelated Donor T Cell Infusion for Hematologic Malignancies After Allo-HSCT
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|ClinicalTrials.gov Identifier: NCT02786485|
Recruitment Status : Withdrawn
First Posted : June 1, 2016
Last Update Posted : October 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes Lymphomas Multiple Myeloma Other High-risk Hematological Malignancies||Biological: rivogenlecleucel Drug: Rimiducid||Phase 1|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Matched Unrelated Donor BPX-501 T Cell Infusion for Adults With Recurrent or Minimal Residual Disease Hematologic Malignancies Post-Allogeneic Transplant|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
Experimental: Rivogenlecleucel & Rimiducid
All subjects will receive 3 courses of rivogenlecleucel (BPX-501 T cells) infusions at 30 day intervals with 2 escalating dose levels (DL). DL1 on Day 0 and DL2 on Days 30 and 60.
Escalating doses of rimiducid (AP1903) (0.1 mg/kg and 0.4 mg/kg) will be investigated for the treatment of aGvHD after rivogenlecleucel infusion.
T cells transduced with iCasp safety switch
Other Name: BPX-501
administered to treat GVHD
Other Name: AP1903
- Adverse events [ Time Frame: 30 days after last dose of study drug (BPX-501 and/or rimiducid) ]Number of adverse events after study drug (BPX-501 and/or rimiducid) administration 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): NCT02786485
|Study Director:||Bellicum Pharmaceuticals||Bellicum Pharmaceuticals, Inc.|