NCT02786485

Brief Summary

This is a Phase I, multicenter, open-label, non-randomized study of matched unrelated donor BPX-501 T cell infusion in adult subjects with hematological malignancies presenting with recurrent disease minimal residual disease (MRD) post-allogeneic transplant.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2016

Shorter than P25 for phase_1 leukemia

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

2.6 years

First QC Date

May 26, 2016

Last Update Submit

October 1, 2020

Conditions

LeukemiaMyelodysplastic SyndromesLymphomasMultiple MyelomaOther High-risk Hematological Malignancies

Keywords

BPX-501RimiducidAP1903Hematological malignanciesHematologic diseasesLeukemias and Myelodysplastic SyndromesLymphomasMultiple myeloma

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Number of adverse events after study drug (BPX-501 and/or rimiducid) administration as a measure of safety

    30 days after last dose of study drug (BPX-501 and/or rimiducid)

Study Arms (1)

Rivogenlecleucel & Rimiducid

EXPERIMENTAL

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.

Biological: rivogenlecleucelDrug: Rimiducid

Interventions

rivogenlecleucelBIOLOGICAL

T cells transduced with iCasp safety switch

Also known as: BPX-501
Rivogenlecleucel & Rimiducid
RimiducidDRUG

administered to treat GVHD

Also known as: AP1903
Rivogenlecleucel & Rimiducid

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged ≥ 18 yrs and ≤ 65 yrs;
  • Clinical diagnosis of one of the following hematological malignancies:
  • Leukemia
  • Myelodysplastic Syndromes
  • Lymphomas
  • Multiple Myeloma
  • Other high-risk hematological malignancy eligible for stem cell transplantation per institutional standard;
  • Recurrent disease that presents ≥100 days after, or minimal residual disease (MRD) that presents ≥ 30 days following a hematopoietic stem cell transplant (HSCT) using a matched unrelated donor located through the National Marrow Donor Program (NMDP);
  • Life expectancy \>10 weeks;
  • Signed donor and patient/guardian informed consent;
  • A 8/8 genotypic identical match as determined by high resolution typing for the following genetic loci: human leukocyte antigen (HLA)-A, HLA-B, HLA-C and HLA-DRB1;
  • Performance status: Karnofsky score \> 50%;
  • Subjects with adequate organ function as measured by:
  • Bone marrow:
  • \> 25% donor T-cell chimerism post-transplant
  • +5 more criteria

You may not qualify if:

  • ≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at the time of screening;
  • Active central nervous system (CNS) involvement with malignant cells (≤ 2 months prior to consenting);
  • Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings); the principal investigator is the final arbiter of this criterion;
  • Positive HIV serology or viral RNA;
  • Pregnancy (positive serum β human chorionic gonadotropin \[HCG\] test) or breast-feeding;
  • Fertile men or women unwilling to use effective forms of birth control or abstinence for one year after transplantation;
  • Bovine product allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesLymphomaMultiple MyelomaHematologic NeoplasmsHematologic Diseases

Interventions

AP 1903 reagent

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemic and Lymphatic DiseasesBone Marrow DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersNeoplasms by Site

Study Officials

  • Bellicum Pharmaceuticals

    Bellicum Pharmaceuticals, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 1, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 5, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share