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LeukemiaPhase 1NCT02477878

Study of Gene Modified Donor T Cell Infusion in Patients With Recurrent Disease After Allogeneic Transplant

A Phase 1 study testing BPX-501 and Rimiducid in people with Leukemia and Myelodysplastic Syndromes, run by Bellicum Pharmaceuticals at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A Phase I study of BPX-501 T cell infusion in adults with recurrent or minimal residual disease (MRD) hematologic malignancies post-allogeneic transplant. The treatment consists of increasing doses of BPX-501 T cell infusions to achieve a clinical response. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Leukemia, Myelodysplastic Syndromes, Lymphoma
What is being tested?
BPX-501 and Rimiducid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
5 sitesUnited States
Study dates
Jul 2016to Jan 2033
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects aged >18yrs and < 65yrs
  • Clinical diagnosis of one of the following adult hematological malignancies
  • Leukemia
  • Myelodysplastic Syndromes
  • Lymphomas
  • Multiple myeloma
Show all 21Show fewer
  • Other high-risk hematologic malignancies eligible for stem cell transplantation per institutional standard Life expectancy >10 weeks
  • Evidence of recurrent disease that presents > 100 days or minimal residual disease (MRD) that presents > 30 days after one of the following:
  • Matched related HSCT
  • Mismatched related HSCT
  • Signed patient informed consent;
  • A minimum genotypic identical match of 4/8 is required, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1
  • Performance status: Karnofsky score > 50%
  • Subjects with adequate organ function as measured by:
  • Bone marrow:
  • > 25% donor T-cell chimerism
  • ANC >1 x 10E9/L
  • Cardiac: left ventricular ejection fraction at rest must be >45%.
  • Hepatic: direct bilirubin ≤ 3 x upper limit of normal, or AST/ALT ≤ 5 x upper limit of normal
  • Renal: creatinine ≤ 2x of ULN for age
  • Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin)

Who cannot join

  • ≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at time of screening;
  • Active CNS involvement by malignant cells;
  • 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 βHCG test) or breast-feeding;
  • Subjects of reproductive potential unwilling to use effective forms of birth control or abstinence for a year after transplantation;
  • Bovine product allergy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • BMT Program at Northside Hospital

    Atlanta, Georgia, 30342

  • Roswell Park

    Buffalo, New York, 14263

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of Kansas

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: A Phase I Study of Donor BPX-501 T Cell Infusion for Adults With Recurrent or Minimal Residual Disease Hematologic Malignancies Post-Allogeneic Transplant

A Phase I study of BPX-501 T cell infusion in adults with recurrent or minimal residual disease (MRD) hematologic malignancies post-allogeneic transplant. The treatment consists of increasing doses of BPX-501 T cell infusions to achieve a clinical response. Rimiducid will be investigated for the treatment of aGvHD after BPX-501 T cell infusion to determine a dose that can mitigate GvHD and preserve the graft versus leukemia effect.

Read the detailed description

Unmanipulated donor lymphocyte infusion (DLI) is used after stem cell transplantation to treat and prevent relapse, to prevent infections and to establish full donor chimerism. The addition of mature T cells which exhibit a broad repertoire of T cell immunity against viral and cancer antigens, might provide a clinical benefit. However, an expected side effect of the presence of mature T cells is the potential occurrence of acute graft-versus-host disease (aGVHD). BPX-501 contains genetically modified donor T cells that have an inducible safety switch iCasp9 suicide gene. Evidence has emerged that escalating DLI has achieved higher clinical response rate with lower GVHD occurrence. Optimization of DLI dose and schedule as well as strategies of donor T-cell manipulation may lead to the consistent ability to separate GVHD from GvL (graft-versus-leukemia) activity and improve the safety of DLI treatment.

Being tested
BPX-501, Rimiducid
Keywords
Adult leukemias and myelodysplasia, Adult lymphomas, Adult multiple myeloma, allogeneic stem cell transplant, donor lymphocyte infusion
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Hematologic Neoplasms, Anemia, Refractory, with Excess of Blasts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BPX-501Biological

    Biological: T cells transduced with CaspaCIDe suicide gene

  • RimiducidDrug

    Also called AP1903

    Rimiducid administered to treat GVHD

Study groups in NCT02477878
Study groupRoleWhat they receive
BPX-501 and RimiducidExperimentalAll subjects will receive 3 cycles of BPX-501 T cell infusions at escalating dose levels (DL). DL1 on Day 0, DL2 on Days 30 and 60. The first dose of BPX-501 T cells will occur ≥30 days after hematopoietic stem cell transplant (HSCT). Two doses of Rimiducid ( 0.1 mg/kg and 0.4 mg/kg) will be investigated for the treatment of aGvHD after BPX-501 T cell infusion.
Receives: Biological: BPX-501; Drug: Rimiducid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BPX-501 Safety

    To evaluate the safety of 2 stratified dose levels of BPX-501 T cell infusions based on patient-donor match in adult subjects with hematological malignancies

    Measured: Month 24

  2. Rimiducid Safety

    evaluate the safety of the infusion of escalating doses of dimerizer drug rimiducid (AP1903) in subjects who develop acute GvHD after BPX-501 infusion

    Measured: Month 24

  3. GvHD

    Assess incidence and severity of acute and chronic GvHD

    Measured: Month 24

  4. Rimiducid Activity

    Determine the effect of Rimiducid on mitigating GvHD

    Measured: Month 24

  5. Rimiducid Efficacy

    Assess time to resolution of GvHD after administration of Rimiducid

    Measured: Month 24

Secondary outcomes (2)

  1. Response Rate

    Measure overall survival, disease free survival and response rates after BPX-501 infusion

    Measured: Month 24

  2. Translational

    Evaluate BPX-501 T cell function

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2015 (estimated)
  2. Study startJul 2016
  3. Primary completion14 Jan 2020
  4. Study completionJan 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02477878
Sponsor's protocol ID
BP-008
Status last verified
Jul 2022
First submitted
18 May 2015
Last updated
12 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
Individual data sharing
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BPX-501 and Rimiducid in people with Leukemia and Myelodysplastic Syndromes, run by Bellicum Pharmaceuticals at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BPX-501 Safety (time frame: Month 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02477878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.

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