Hematologic CancerPhase 1/2GLIDENCT03091933
Antiminor Histocompatibility Complex (MiHA) T Cells for Patients With Relapsed Hematologic Malignancies Following Matched HSCT (Guided Lymphocyte Immunopeptide Derived Expansion)
A Phase 1/2 study testing GLIDE in people with Hematologic Cancer and Relapse Leukemia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
This study will evaluate the safety of infusing an anti-MiHA T cell line in patients suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematologic Cancer, Relapse Leukemia, Relapsed Adult ALL
- What is being tested?
- GLIDE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2017to 31 Mar 2019
- Phase
- Phase 1/2
- 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
- Prior allogeneic HLA-matched stem cell transplantation
- Any of the following hematologic malignancies:
- Acute myeloid leukemia (AML)
- Acute lymphoblastic leukemia (ALL)
- Biphenotypic leukemia
- Chronic lymphoblastic leukemia (CLL)
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- Hodgkin Lymphoma
- Non-Hodgkin Lymphoma (NHL)
- Multiple Myeloma (MM)
- Myelodysplastic syndrome (MDS)
- Presence of HLA2:01 and / or HLA44:02 and / or HLA-B*44:03, HLA-A*01:01; HLA-A*03:01; HLA-A*11:01;HLA A*24:02; HLA-A*29:02; HLA-A*32:01; HLA-B*07:02; HLA-B*08:01; HLA B*13:02; HLA-B*14:02; HLA-B*15:01; HLA-B*18:01; HLA-B*27:05; HLA B*35:01; HLA-B*40:01; or HLA-B*57:01
- At least 6 months after allogeneic hematopoietic stem cell transplantation
- Presence of detectable malignant disease post-transplantation in the form of molecular, cytogenetic or hematologic relapse of the malignant disorder.
- Eligible to receive cytoreductive chemotherapy
- Original stem cell donor available for leukocyte donation.
- ECOG performance status ≤2.
- Ability to provide written consent.
- Accessible for treatment and follow up.
- Presence of a targetable MiHA based on exome sequencing of the patient and donor
Who cannot join
- Active acute GVHD > grade I
- Prior grade III-IV acute GVHD within the last year
- Uncontrolled chronic GVHD
- Prior administration of donor lymphocyte infusion (DLI)
- Use of T-cell depleting antibodies in the previous 30 days
- Treatment with immune suppressors (oral or parenteral steroids corresponding to a dose of prednisone greater than 7.5 mg/day, calcineurine inhibitors, rapamycin, mycophenolate mofetil, etc) during the last 30 days.
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- Uncontrolled active infection
- Uncontrolled central nervous system involvement by leukemia cells (blasts).
- AST or ALT > 2.5 x ULN (CTCAE grade 2)
- Bilirubin > 1.5 x ULN (CTCAE grade 2)
- Creatinine clearance < 50 mL/min
- Positive test for human immunodeficiency virus (HIV)
- Positive pregnancy test (women of childbearing age only)
- Lactating women: the safety of this therapy on breast milk is not known.
- Estimated probability of surviving less than 3 months
- Known allergy to any of the components of GLIDE (e.g., dimethyl sulfoxide)
- Intercurrent illness or medical condition precluding safe administration of the planned protocol treatment or required follow-up.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CIUSSS d l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T 2M4
Jean-Guy Némorin, PhD, 514-252-3400 ext. 6247, jgnemorin@centrec3i.com
Stéphanie Thiant, PhD, 214-252-3400 ext. 4681, sthiant.hmr@ssss.gouv.qc.ca
About this study
Official title: An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Anti-minor Histocompatibility Complex (MiHA) Donor T-lymphocytes Expanded ex Vivo, in Patients With a Hematologic Malignancy, With Molecular or Clinical Relapse After Hematopoietic Stem Cell Transplantation From a Matched Donor
This study will evaluate the safety of infusing an anti-MiHA T cell line in patients suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor.
Read the detailed description
The GLIDE-201/44 trial primarily aims to test the safety of anti-MiHA T cell line in patients suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor. The anti-MiHA T cell lines are derived from the matched donor for the patient, the original donor for a given patient. Both the patient and the matched donor will undergo screening to determine the expression of targetable MiHAs. Upon identification of the target MiHAs, donor cells will be collected through apheresis and primed against the selected MiHA. In this setting, the GLIDE 201/44 product will be cryopreserved, thawed and administered as a single infusion at a target dose of 4x10E+07 viable T cells/m2 (range of dose is 0.4 4x10E+07 viable T cells/m2). A second infusion can be offered to the patients after an observation period of 42 days upon clinical evaluation by the treating physician. In the absence of secondary adverse events following the initial infusion, a second infusion of the GLIDE 201/44 product could be administered at a dose level up to 3-5 fold the original dose.
- Conditions
- Hematologic Cancer, Relapse Leukemia, Relapsed Adult ALL, Relapsed Adult AML, Relapsed CLL, Relapsed Non Hodgkin Lymphoma
- Being tested
- GLIDE
- Keywords
- allogeneic hematopoietic stem cell transplantation, relapsed hematopoietic malignancy, HLA matched donor, minor histocompatibilty antigen (MiHA)
- Medical subject headings
- Hematologic Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Hodgkin Disease, Myelodysplastic Syndromes, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLIDEBiological
Gudide Lymphocyte by Immunopeptide Derived Expansion (GLIDE) is an anti- Minor histocompatibility (MiHA) cell line
| Study group | Role | What they receive |
|---|---|---|
| GLIDE | Experimental | GLIDE single infusion at a target dose of 4x107 viable T-cells/m2 Receives: Biological: GLIDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-hematologic toxicity related to GLIDE post injection
No death or other toxic events directly related to GLIDE injection
Measured: 6 months
Secondary outcomes (7)
Response of hematologic malignancy (acute leukemia (ALL, AML, biphenotypic), CLL, HL, NHL, MM or MDS) post-injection
Disease progression following GLIDE injection
Measured: up to 12 months
Incidence and severity of acute and chronic graft versus host disease (GvHD)
Progression (if any) or induction of GvHD
Measured: up to 12 months
Persistence of GLIDE in the host and homing to peripheral blood, bone marrow and other tissues
Monitoring of GLIDE product persistence in host
Measured: up to 12 months
Non-Relapse mortality (NRM)
Time to deaths without relapse/recurrence
Measured: up to 12 months
Relapse-incidence (RI)
Time to relapse
Measured: up to 12 months
Overall survival (OS)
Time to death, irrespective of the cause
Measured: up to 12 months
Progression-free survival (PFS)
It is time to any of the following: OS, RI, NRM, Time to relapse, Relapse free survival
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start6 Feb 2017
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- exploratory, open-label
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis-Claude Roy, MD PhD, Principal investigator, CIUSSS d l'Est-de-l'Île-de-MontréalJean-Sébastien Delisle, MD PhD, Principal investigator, CIUSSS d l'Est-de-l'Île-de-MontréalSilvy Lachance, MD, Principal investigator, CIUSSS d l'Est-de-l'Île-de-Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091933
- Sponsor's protocol ID
- CR-MIHA-001
- Acronym
- GLIDE
- Status last verified
- Dec 2017
- First submitted
- 21 Mar 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study end
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Anti-minor Histocompatibility Complex (MiHA) Donor T-lymphocytes Expanded ex Vivo, in Patients With a Hematologic Malignancy, With Molecular or Clinical Relapse After Hematopoietic Stem Cell Transplantation From a Matched Donor
- ClinicalTrials.gov ID
- NCT03091933
- Acronym / sponsor ID
- GLIDE / CR-MIHA-001
- Conditions
- Hematologic Cancer, Relapse Leukemia, Relapsed Adult ALL, Relapsed Adult AML, Relapsed CLL, Relapsed Non Hodgkin Lymphoma
- Keywords
- allogeneic hematopoietic stem cell transplantation, relapsed hematopoietic malignancy, HLA matched donor, minor histocompatibilty antigen (MiHA)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety of infusing an anti-MiHA T cell line in patients suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor.
Detailed description
The GLIDE-201/44 trial primarily aims to test the safety of anti-MiHA T cell line in patients suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor. The anti-MiHA T cell lines are derived from the matched donor for the patient, the original donor for a given patient. Both the patient and the matched donor will undergo screening to determine the expression of targetable MiHAs. Upon identification of the target MiHAs, donor cells will be collected through apheresis and primed against the selected MiHA. In this setting, the GLIDE 201/44 product will be cryopreserved, thawed and administered as a single infusion at a target dose of 4x10E+07 viable T cells/m2 (range of dose is 0.4 4x10E+07 viable T cells/m2). A second infusion can be offered to the patients after an observation period of 42 days upon clinical evaluation by the treating physician. In the absence of secondary adverse events following the initial infusion, a second infusion of the GLIDE 201/44 product could be administered at a dose level up to 3-5 fold the original dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- exploratory, open-label
| Arm | Type | Receives |
|---|---|---|
| GLIDE | Experimental | Biological: GLIDEGLIDE single infusion at a target dose of 4x107 viable T-cells/m2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Prior allogeneic HLA-matched stem cell transplantation
- Any of the following hematologic malignancies:
- Acute myeloid leukemia (AML)
- Acute lymphoblastic leukemia (ALL)
- Biphenotypic leukemia
Key exclusion criteria (17 listed)
- Active acute GVHD > grade I
- Prior grade III-IV acute GVHD within the last year
- Uncontrolled chronic GVHD
- Prior administration of donor lymphocyte infusion (DLI)
- Use of T-cell depleting antibodies in the previous 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLIDEGudide Lymphocyte by Immunopeptide Derived Expansion (GLIDE) is an anti- Minor histocompatibility (MiHA) cell line | Biological | GLIDE |
Primary outcome
Non-hematologic toxicity related to GLIDE post injection
Time frame: 6 months
No death or other toxic events directly related to GLIDE injection
7 secondary outcomes
Response of hematologic malignancy (acute leukemia (ALL, AML, biphenotypic), CLL, HL, NHL, MM or MDS) post-injection
Time frame: up to 12 months
Incidence and severity of acute and chronic graft versus host disease (GvHD)
Time frame: up to 12 months
Persistence of GLIDE in the host and homing to peripheral blood, bone marrow and other tissues
Time frame: up to 12 months
Non-Relapse mortality (NRM)
Time frame: up to 12 months
Relapse-incidence (RI)
Time frame: up to 12 months
Overall survival (OS)
Time frame: up to 12 months
Progression-free survival (PFS)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study end
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis-Claude Roy, MD PhD principal investigator
CIUSSS d l'Est-de-l'Île-de-Montréal
Jean-Sébastien Delisle, MD PhD principal investigator
CIUSSS d l'Est-de-l'Île-de-Montréal
Silvy Lachance, MD principal investigator
CIUSSS d l'Est-de-l'Île-de-Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GLIDE in people with Hematologic Cancer and Relapse Leukemia, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 19 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Guy Némorin, PhD ((514) 252-3400 ext. 6247, jgnemorin@centrec3i.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-hematologic toxicity related to GLIDE post injection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2017.