Acute Lymphoblastic LeukemiaPhase 1/2NCT01744223
Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant
A Phase 1/2 study testing BPX-501 dose 1, Rimiducid and BPX-501 dose 2 in people with Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia, run by Bellicum Pharmaceuticals at 8 sites in United States.
Trial summary
This study will evaluate patients with blood cell cancers who are going to have an allogeneic (donor) blood stem cell transplant from a partially matched relative. The research study will test whether immune cells, called T cells, which come from the donor relative and are specially grown in the laboratory and then… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Lymphoma
- What is being tested?
- BPX-501 dose 1, Rimiducid and BPX-501 dose 2
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2013to Oct 2032
- Phase
- Phase 1/2
- 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
- Signed informed consent
- Age ≥ 18 years and ≤ 65 years
- Deemed eligible for allogeneic stem cell transplantation
- Lack of suitable conventional donor (i.e. 8/8 related or unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
- HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, and DRBl, and loci
- A minimum genotypic identical match of 4/8 is required.
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- The donor and recipient must be identical, 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
- Subjects with adequate organ functions as measured by:
- Cardiac: Left ventricular ejection fraction at rest must be ≥ 45%
- Hepatic: Bilirubin ≤ 2.5 mg/dL and ALT, AST and Alkaline Phosphatase < 5 x ULN
- Renal: Serum creatinine within normal range for age or creatinine clearance, or with a recommended GFR ≥ 50 mL/min/1.73m2
- Pulmonary: FEV 1, FVC and DLCO (diffusion capacity) ≥ 50% predicted (corrected for hemoglobin); or O2 saturation > 92% on room air
- Clinical diagnosis of one of the following:
- Acute Leukemia (includes T lymphoblastic lymphoma) in 2nd or subsequent complete remission (CR) i. Acute Lymphoblastic Leukemia (ALL) in 2nd or subsequent CR. ALL shall be morphologic remission at the time of transplant. Morphologic remission is defined that subjects with normal neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and no extramedullary disease ii. Acute Myeloid Leukemia (AML) in 2nd or subsequent CR with or without persistent minimal residual disease b. High-risk ALL in 1st CR (including features such as those in i-iii) i. Adverse cytogenetics such as t(9;22), t(1;19), t(4;11), MLL rearrangements ii. Subjects over 30 years of age, or iii. Time to complete remission was greater than 4 weeks. c. High-risk AML in 1st CR (including features such as those listed in i-vii) i. Greater than 1 cycle of induction therapy required to achieve remission ii. Preceding myelodysplastic syndrome (MDS) iii. Presence of FLT3 abnormalities iv. FAB M6 or M7 leukemia v. Adverse cytogenetics for overall survival such as those associated with MDS vi. Complex karyotype (>3 abnormalities), or vii. Any of the following: inv(3) or t(3;3), t(6;9), t(6;11), + 8 [alone or with other abnormalities except for t(8;21), t(9;11), inv(16) or t(16;16)], t(l1;19)(q23;p13.1) d. High risk Myelodysplastic Syndrome e. Non-Hodgkin's Lymphoma relapsed after autologous transplantation f. Non-Hodgkin's Lymphoma with insufficient autologous hematopoietic stem cells to undergo autologous transplantation g. CML i. in first chronic phase that has not attained at least a complete cytogenetic remission after exposure to at least 3 tyrosine kinase inhibitors ii. in accelerated phase that has not attained at least a complete cytogenetic remission iii. in second chronic phase
- Performance status: Karnofsky score ≥60%.
- Patient with hematologic malignancy not responding to /or not eligible for conventional therapy and are approved by Sponsor
Who cannot join
- HLA 8/8 allele matched (HLA-A,-B,-Cw,-DRBl) related or unrelated donor able to donate.
- Autologous hematopoietic stem cell transplant < 3 months prior to enrollment.
- Pregnancy or breast-feeding.
- Evidence of HIV infection or known HIV positive serology.
- Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings). The treating physician will make final determination.
- Non-hematologic malignancy within prior three (3) years, with the exception of squamous cell or basal cell skin carcinoma.
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- Prior allogeneic hematopoietic stem cell transplant.
- Subjects with a history of primary idiopathic myelofibrosis.
- Bovine product allergy.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Roswell Park Cancer Institute
Buffalo, New York, 14263
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Baylor Sammons Cancer Center
Dallas, Texas, 75246
UT Southwestern Medical Center
Dallas, Texas, 75390
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Oregon Health & Science University
Portland, Oregon, 97239
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: A Phase 1/2 Dose Escalation Study Evaluating Safety and Feasibility of BPX-501 T Cells After Partially Mismatched, Related, T Cell-Depleted HSCT (Hematopoietic Stem Cell Transplant)
This study will evaluate patients with blood cell cancers who are going to have an allogeneic (donor) blood stem cell transplant from a partially matched relative. The research study will test whether immune cells, called T cells, which come from the donor relative and are specially grown in the laboratory and then given back to the patient along with the stem cell transplant (T cell addback), can help the immune system recover faster after the transplant. As a safety measure, these T cells have been "programmed" with a "self-destruct switch" so that if, after they have been given to the patient, the T cells start to react against the tissues (called "graft versus host" disease, GVHD), the T cells can be destroyed.
Read the detailed description
This is a Phase1/2 dose escalation study evaluating the safety and feasibility of BPX-501 infused after partially mismatched, related (haploidentical), T cell-depleted HSCT. The purpose of this clinical trial is to determine whether BPX-501 infusion can facilitate engraftment, enhance immune reconstitution and potentially improve the graft versus leukemia (GVL) effect, with the potential for reducing the severity and duration of severe acute graft versus host disease (GvHD). The trial will evaluate the treatment of GvHD by the infusion of dimerizer drug (Rimiducid) in those subjects who present with GvHD that does not adequately respond to standard of care therapy.
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Lymphoma, Myelodysplastic Syndromes
- Being tested
- BPX-501 dose 1, Rimiducid, BPX-501 dose 2, BPX-501 dose 3, BPX-501 dose 4
- Keywords
- iCaspase9, iCasp9, Inducible Caspase, AP1903, Dimerizer drug, T depleted, Suicide gene, CD-34 selection, haplotransplantation, Graft versus host disease, Allogenic transplantation
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Myelodysplastic Syndromes, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPX-501 dose 1Biological
Also called rivogenlecleucel
Subjects will receive 2x10E5 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.
RimiducidDrug
Also called AP1903
Dimerizer drug administered by intravenous infusion in those subjects who develop GVHD after infusion of BPX-501 cells.
BPX-501 dose 2Biological
Also called rivogenlecleucel
Subjects will receive 5x10E5 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.
BPX-501 dose 3Biological
Also called rivogenlecleucel
Subjects will receive 1x10E6 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.
BPX-501 dose 4Biological
Also called rivogenlecleucel
Subjects will receive 3x10E6 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.
SCTProcedure or surgery
all subjects will receive an alpha beta depleted donor transplant as part of treatment
| Study group | Role | What they receive |
|---|---|---|
| SCT, BPX-501 dose 1, Rimiducid if needed | Experimental | 2x10E5 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant.
Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid. Receives: Biological: BPX-501 dose 1; Drug: Rimiducid; Procedure: SCT |
| SCT, BPX-501 dose 2, Rimiducid if needed | Experimental | 5x10E5 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant.
Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid. Receives: Drug: Rimiducid; Biological: BPX-501 dose 2; Procedure: SCT |
| SCT, BPX-501 dose 3, Rimiducid if needed | Experimental | 1x10E6 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant.
Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid. Receives: Drug: Rimiducid; Biological: BPX-501 dose 3; Procedure: SCT |
| SCT, BPX-501 dose 4, Rimiducid if needed | Experimental | 3x10E6 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant .
Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid. Receives: Drug: Rimiducid; Biological: BPX-501 dose 4; Procedure: SCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
BPX-501 Safety
To evaluate the safety of infusion of each of 4 dose cohorts of BPX-501 (2x105, 5x105, 1x106 and 3x106 cells/kg) after transplantation of partially mismatched T cell depleted hematopoietic stem cell transplant (HSCT)
Measured: 24 months
Rimiducid Safety
To evaluate the safety of the infusion of the rimiducid in subjects who received BPX-501 and have developed visceral or steroid refractory graft-versus-host-disease
Measured: 24 months
MTD
To determine the maximum dose of BPX-501 (up to 3x106 cells/kg) that results in an adjusted cumulative incidence by Day 100 of no more than 45% Grade II - IV aGVHD and / or no more than 17% Grade III -IV aGVHD.
Measured: 24 months
Immune Reconstitution
To assess immune reconstitution for each dose cohort
Measured: 24 months
Secondary outcomes (9)
Efficacy- NRM
Non-Relapse Mortality (NRM)
Measured: 100, 180 days and 1 year
Efficacy- DFS
Disease-free survival
Measured: 24 months
Efficacy- TRM
Transplant related mortality (TRM)
Measured: 24 months
Efficacy- Relapse
Incidence of Relapse
Measured: 24 months
Incidence of engraftment
Evaluation of neutrophil and platelet engraftment, kinetics of donor cell engraftment and graft failure
Measured: 24 months
GvHD
Incidence and severity of acute and chronic GvHD
Measured: 24 months
GvHD post Rimiducid Administration
Time to resolution of acute GvHD after administration of Rimiducid
Measured: 24 months
BPX-501 Safety Profile
Characterize the safety profile of BPX-501 including evaluation of high grade toxicity and infectious complications
Measured: 24 months
Pharmacokinetics of Rimiducid
Pharmacokinetic disposition of Rimiducid
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startMar 2013
- Primary completion9 Oct 2019
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bellicum Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bellicum Pharmaceuticals, Study director, Bellicum Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744223
- Sponsor's protocol ID
- BP-001
- Status last verified
- Jul 2022
- First submitted
- 5 Dec 2012
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Dose Escalation Study Evaluating Safety and Feasibility of BPX-501 T Cells After Partially Mismatched, Related, T Cell-Depleted HSCT (Hematopoietic Stem Cell Transplant)
- ClinicalTrials.gov ID
- NCT01744223
- Acronym / sponsor ID
- BP-001
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Lymphoma, Myelodysplastic Syndromes
- Keywords
- iCaspase9, iCasp9, Inducible Caspase, AP1903, Dimerizer drug, T depleted, Suicide gene, CD-34 selection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Bellicum PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- Oct 2032 (estimated)
- First posted
- 6 Dec 2012 (estimated)
- 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 patients with blood cell cancers who are going to have an allogeneic (donor) blood stem cell transplant from a partially matched relative. The research study will test whether immune cells, called T cells, which come from the donor relative and are specially grown in the laboratory and then given back to the patient along with the stem cell transplant (T cell addback), can help the immune system recover faster after the transplant. As a safety measure, these T cells have been "programmed" with a "self-destruct switch" so that if, after they have been given to the patient, the T cells start to react against the tissues (called "graft versus host" disease, GVHD), the T cells can be destroyed.
Detailed description
This is a Phase1/2 dose escalation study evaluating the safety and feasibility of BPX-501 infused after partially mismatched, related (haploidentical), T cell-depleted HSCT. The purpose of this clinical trial is to determine whether BPX-501 infusion can facilitate engraftment, enhance immune reconstitution and potentially improve the graft versus leukemia (GVL) effect, with the potential for reducing the severity and duration of severe acute graft versus host disease (GvHD). The trial will evaluate the treatment of GvHD by the infusion of dimerizer drug (Rimiducid) in those subjects who present with GvHD that does not adequately respond to standard of care therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SCT, BPX-501 dose 1, Rimiducid if needed | Experimental | Biological: BPX-501 dose 1, Drug: Rimiducid, Procedure: SCT2x10E5 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant. Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid. |
| SCT, BPX-501 dose 2, Rimiducid if needed | Experimental | Drug: Rimiducid, Biological: BPX-501 dose 2, Procedure: SCT5x10E5 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant. Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid. |
| SCT, BPX-501 dose 3, Rimiducid if needed | Experimental | Drug: Rimiducid, Biological: BPX-501 dose 3, Procedure: SCT1x10E6 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant. Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid. |
| SCT, BPX-501 dose 4, Rimiducid if needed | Experimental | Drug: Rimiducid, Biological: BPX-501 dose 4, Procedure: SCT3x10E6 BPX-501 (rivogenlecleucel) cells per kg infused after TCR alpha beta depleted donor stem cell transplant . Rimiducid: Dimerizer drug administered by intravenous infusion in those subjects with acute GVHD with no response to steroids and/or other aGVHD medications or worsening in stage or grade of aGVHD after 48 hours. Subjects with chronic GvHD who do not respond to steroids/systemic therapies within 7 days, or there is a worsening in cGVHD, patients may then receive rimiducid. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent
- Age ≥ 18 years and ≤ 65 years
- Deemed eligible for allogeneic stem cell transplantation
- Lack of suitable conventional donor (i.e. 8/8 related or unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
- HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, and DRBl, and loci
Key exclusion criteria (9 listed)
- HLA 8/8 allele matched (HLA-A,-B,-Cw,-DRBl) related or unrelated donor able to donate.
- Autologous hematopoietic stem cell transplant < 3 months prior to enrollment.
- Pregnancy or breast-feeding.
- Evidence of HIV infection or known HIV positive serology.
- Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings). The treating physician will make final determination.
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 |
|---|---|---|
| BPX-501 dose 1Also: rivogenlecleucelSubjects will receive 2x10E5 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant. | Biological | SCT, BPX-501 dose 1, Rimiducid if needed |
| RimiducidAlso: AP1903Dimerizer drug administered by intravenous infusion in those subjects who develop GVHD after infusion of BPX-501 cells. | Drug | SCT, BPX-501 dose 1, Rimiducid if needed, SCT, BPX-501 dose 2, Rimiducid if needed, SCT, BPX-501 dose 3, Rimiducid if needed, SCT, BPX-501 dose 4, Rimiducid if needed |
| BPX-501 dose 2Also: rivogenlecleucelSubjects will receive 5x10E5 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant. | Biological | SCT, BPX-501 dose 2, Rimiducid if needed |
| BPX-501 dose 3Also: rivogenlecleucelSubjects will receive 1x10E6 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant. | Biological | SCT, BPX-501 dose 3, Rimiducid if needed |
| BPX-501 dose 4Also: rivogenlecleucelSubjects will receive 3x10E6 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant. | Biological | SCT, BPX-501 dose 4, Rimiducid if needed |
| SCTall subjects will receive an alpha beta depleted donor transplant as part of treatment | Procedure or surgery | SCT, BPX-501 dose 1, Rimiducid if needed, SCT, BPX-501 dose 2, Rimiducid if needed, SCT, BPX-501 dose 3, Rimiducid if needed, SCT, BPX-501 dose 4, Rimiducid if needed |
Primary outcome
BPX-501 Safety
Time frame: 24 months
To evaluate the safety of infusion of each of 4 dose cohorts of BPX-501 (2x105, 5x105, 1x106 and 3x106 cells/kg) after transplantation of partially mismatched T cell depleted hematopoietic stem cell transplant (HSCT)
Rimiducid Safety
Time frame: 24 months
To evaluate the safety of the infusion of the rimiducid in subjects who received BPX-501 and have developed visceral or steroid refractory graft-versus-host-disease
MTD
Time frame: 24 months
To determine the maximum dose of BPX-501 (up to 3x106 cells/kg) that results in an adjusted cumulative incidence by Day 100 of no more than 45% Grade II - IV aGVHD and / or no more than 17% Grade III -IV aGVHD.
Immune Reconstitution
Time frame: 24 months
To assess immune reconstitution for each dose cohort
9 secondary outcomes
Efficacy- NRM
Time frame: 100, 180 days and 1 year
Efficacy- DFS
Time frame: 24 months
Efficacy- TRM
Time frame: 24 months
Efficacy- Relapse
Time frame: 24 months
Incidence of engraftment
Time frame: 24 months
GvHD
Time frame: 24 months
GvHD post Rimiducid Administration
Time frame: 24 months
BPX-501 Safety Profile
Time frame: 24 months
Pharmacokinetics of Rimiducid
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Bellicum Pharmaceuticals study director
Bellicum Pharmaceuticals
8 sites 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 BPX-501 dose 1, Rimiducid and BPX-501 dose 2 in people with Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia, run by Bellicum Pharmaceuticals at 8 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 16 inclusion and 9 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 8 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 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?
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: 24 months). The study lists 4 primary outcomes in all. 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 12 Jul 2022.