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LeukemiaPhase 1NCT02786485

Study of Matched Unrelated Donor T Cell Infusion for Hematologic Malignancies After Allo-HSCT

A Phase 1 study testing rivogenlecleucel and Rimiducid in people with Leukemia and Myelodysplastic Syndromes, run by Bellicum Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Leukemia, Myelodysplastic Syndromes, Lymphomas
What is being tested?
rivogenlecleucel and Rimiducid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
May 2016to Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

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 ≥ 18 yrs and ≤ 65 yrs;
  • Clinical diagnosis of one of the following hematological malignancies:
  • Leukemia
  • Myelodysplastic Syndromes
  • Lymphomas
  • Multiple Myeloma
Show all 20Show fewer
  • 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
  • Absolute neutrophil count (ANC) >1 x 109/L
  • Cardiac: left ventricular ejection fraction (LVEF) at rest ≥ 45%
  • Pulmonary: forced expiratory volume (FEV) 1, forced vital capacity (FVC), diffusion capacity of lunch for carbon monoxide (DLCO) ≥ 50% predicted (corrected for hemoglobin)
  • Hepatic: direct bilirubin ≤ 3x upper limit of normal (ULN), or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5x ULN
  • Renal: creatinine ≤ 2x of ULN for age.

Who cannot join

  • ≥ 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.

About this study

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

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.

Read the detailed description

Un-manipulated 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 antigens, as well as against 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). The use of a suicide gene switch which would trigger the initiation of the apoptosis of the alloreactive T cells by the infusion of a drug would represent the potential optimal strategy for restoring early immunity with a built in "safety switch" against GvHD side effects. Evidence has emerged that low-dose DLI followed by dose escalation can achieve 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 graft-versus-tumor (GvT) activity and improve the safety of DLI treatment. Our strategy is to infuse escalating doses of manipulated T cells (from the same donor who provided the original hematopoietic stem cell graft) in adults and children with recurrent or minimal residual disease (MRD) hematologic malignancies post-allogeneic transplant to accelerate immune reconstitution thus improving graft versus leukemic effect while reducing the severity of GvHD.

Being tested
rivogenlecleucel, Rimiducid
Keywords
BPX-501, Rimiducid, AP1903, Hematological malignancies, Hematologic diseases, Leukemias and Myelodysplastic Syndromes, Lymphomas, Multiple myeloma
Medical subject headings
Leukemia, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Hematologic Neoplasms, Hematologic Diseases

What participants receive

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

  • rivogenlecleucelBiological

    Also called BPX-501

    T cells transduced with iCasp safety switch

  • RimiducidDrug

    Also called AP1903

    administered to treat GVHD

Study groups in NCT02786485
Study groupRoleWhat they receive
Rivogenlecleucel & RimiducidExperimentalAll 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.
Receives: Biological: rivogenlecleucel; Drug: Rimiducid

What is being measured

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

  1. Adverse events

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

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

Timeline

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

  1. First posted1 Jun 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionDec 2018
  4. Study completionDec 2018

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02786485
Sponsor's protocol ID
BP-008-MUD
Status last verified
Oct 2020
First submitted
26 May 2016
Last updated
5 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rivogenlecleucel and Rimiducid in people with Leukemia and Myelodysplastic Syndromes, run by Bellicum Pharmaceuticals.

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 20 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: withdrawn, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Adverse events (time frame: 30 days after last dose of study drug (BPX-501 and/or rimiducid)). 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 NCT02786485.

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 5 Oct 2020.

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