AML - Acute Myeloid LeukemiaPhase 1T-allo10NCT03198234
Use of T-allo10 in Hematopoietic Stem Cell Transplantation (HSCT) for Blood Disorders
A Phase 1 study testing T-allo10 in people with AML - Acute Myeloid Leukemia and MDS (Myelodysplastic Syndrome), run by Roncarolo, Maria Grazia, MD at 1 site in United States.
Trial summary
A significant number of patients with hematologic malignancies need a hematopoietic stem cell transplant (HSCT) to be cured. Only about 50% of these patients have a fully matched donor, the remaining patients will require an HSCT from a mismatched related or unrelated donor. Read more about this study
- Who is it for?
- Ages 3 to 45 years
- Conditions the study is for
- AML - Acute Myeloid Leukemia, MDS (Myelodysplastic Syndrome), Mixed Phenotype Acute Leukemia
- What is being tested?
- T-allo10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 11 Nov 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Eligible diseases include:
- Acute Lymphoblastic Leukemia (B- or T-ALL)
- Complete Response (CR)1-ultra high risk features
- Unfavorable cytogenetics
- Hypodiploidy
- Induction failure
Show all 34Show fewer
- Minimal Residual Disease (MRD) positive after consolidation
- CR-2:
- Any of the high risk features listed in CR1
- B-ALL: any relapse considered eligible for transplant
- T- ALL
- CR-3-any
- Acute Myeloid Leukemia
- MRD >5% at day 22 induction 1
- MRD >0.1% after induction 2
- FLT/ITD with allelic ratio > 0.4 and MRD >0.1% at day 22 or 29 induction 1
- Translocation (6:9), (8:6), (16:21), monosomy 7, monosomy 5, 5q
- M7 with KMT2A rearrangements, inv(16)(p13.3q24.3) [CBFA2T3-GLIS2] or t(11;12)(p15;p13) [NUP98-KDM5A]
- AML in 2nd or subsequent CR
- Therapy related or Secondary AML
- Refractory anemia with excess blasts (RAEB)2
- Myelodysplastic syndrome D. Mixed Phenotype Acute Leukemia MRD>1% after consolidation E. Non-Hodgkin's lymphoma (NHL) or Hodgkin's lymphoma (HL) beyond first remission
- Age ≥3 to ≤45 years old. Subjects 1 and 2 (in Cohort 1) will be ≥ 12 years old
- Available mismatched related donor (mMRD) or mismatched unrelated donor (mMUD), Human leukocyte antigen (HLA) matched 8/10 or 9/10
- Lansky (age <16) or Karnofsky (age ≥16) performance status ≥80%
- Able and willing to provide written, signed informed consent (assent as appropriate)
- Have adequate organ function defined as the following:
- Serum Creatinine <1.5 X upper limit of normal (ULN) or 24-hour creatinine clearance >50 ml/min
- Serum bilirubin ≤ 2 x ULN
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- ≤10 x ULN
- Diffusion Capacity of the Lungs (DLCO) >60% predicted (in children, O2 saturation >92% on room air)
- Left ventricular ejection fraction >45% (in children, shortening fraction >26%)
- Male and female subjects of child bearing potential must agree to use an effective method of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any chronic GvHD.
Who cannot join
- Prior bone marrow or peripheral blood HSCT within the last 6 (six) months
- HLA-matched related or unrelated donor available
- Any active, uncontrolled infection at the time of enrollment
- Pregnant or lactating females
- Any severe concurrent disease which, in the judgement of the investigator, would place the patient at increased risk during participation in the study
- Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction or on treatment to support cardiac dysfunction
Show all 10Show fewer
- HIV positive
- Non-cooperative behavior or non-compliance of the patient and/or of his/her family
- Received another investigational agent within 30 days of enrollment
- Patients with Down's syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94304
About this study
Official title: Use of T-allo10 Cell Infusions Combined With Mismatched Related or Mismatched Unrelated Hematopoietic Stem Cell Transplantation (HSCT) for Hematologic Malignancies
A significant number of patients with hematologic malignancies need a hematopoietic stem cell transplant (HSCT) to be cured. Only about 50% of these patients have a fully matched donor, the remaining patients will require an HSCT from a mismatched related or unrelated donor. Almost 60% of these mismatched donor HSCTs will result in graft-versus-host disease (GvHD), which can cause significant morbidity and increased non-relapse mortality. GvHD is caused by the donor effector T cells present in the HSC graft that recognize and react against the mismatched patient's tissues.
Researchers and physicians at Lucile Packard Children's Hospital, Stanford are working to prevent GvHD after HSCT with a new clinical trial. The objective of this clinical program is to develop a cell therapy to prevent GvHD and induce graft tolerance in patients receiving mismatched unmanipulated donor HSCT. The cell therapy consists of a cell preparation from the same donor of the HSCT (T-allo10) containing T regulatory type 1 (Tr1) cells able to suppress allogenic (host-specific) responses, thus decreasing the incidence of GvHD.
Read more
This is the first trial of its kind in pediatric patients and is only available at Lucile Packard Children's Hospital, Stanford.
The purpose of this phase 1 study is to determine the safety and tolerability of a cell therapy, T-allo10, to prevent GvHD in patients receiving mismatched related or mismatched unrelated unmanipulated donor HSCT for hematologic malignancies.
Read the detailed description
Patients ages 3-30 years, with hematologic malignancies undergoing mismatched related or unrelated donor transplant will receive conditioning chemotherapy with Total body radiation and cyclophosphamide, according to the standard procedure.
The investigators plan to infuse the donor T-allo10 product one day before HSCT so that the Tr1 cells contained within the T-allo10 product will be able to prevent anti-host alloreactivity of the T cells present within the unmanipulated HSC graft. Indeed, Tr1 cells best exert their suppressive activity at the time of effector T cell activation, occurring when the T cells present in the HSC graft will be transferred to the patient ; therefore, the investigators expect that the early infusion of T-allo10 cells will optimally modulate anti-host alloreactivity of the donor T cells and prevent GvHD.
Immunosuppression will also be administered at the time of HSCT.
Up to 27 eligible patients will be given the T-allo10 product sequentially in 3 escalating dose cohorts to determine the maximum tolerated dose (or the highest dose tested if no maximum tolerated dose is reached). Each cohort will begin by evaluating 3 patients. The patients in each cohort will be staggered by 28 days and each succeeding patient will be enrolled no sooner than the 29 day after the preceding patient's infusion of T-allo10.
- If no patient in a cohort develops a dose limiting toxicity (DLT) following infusion of the investigational cellular product, the investigators will start enrolling patients at the next higher cell dose after completing the 28-day safety evaluation of the 3rd patient in the dose cohort.
- If one out of 3 patients in a cohort has a DLT, 3 additional patients will be evaluated at the same dose level.
- If one out of 6 patients experiences a DLT, dose escalation will occur.
- If 2 out of ≤ 6 patients experience a DLT, dose escalation will cease and that dose will be designated the maximally administered dose.
- Up to three (3) additional patients will be entered at the next lowest dose level if only 3 patients were treated previously at that dose
- Conditions
- AML - Acute Myeloid Leukemia, MDS (Myelodysplastic Syndrome), Mixed Phenotype Acute Leukemia, NHL - Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, ALL
- Being tested
- T-allo10
- Keywords
- Pediatric, GvHD, Hematopoietic Stem Cell Transplantation, Stem Cells, Transplant, BMT - bone marrow transplant
- Medical subject headings
- Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts, Leukemia, Biphenotypic, Acute, Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-allo10Biological
The T-allo10 drug product consists of donor derived, host (patient) alloantigen hyporesponsive (anergic) CD4+ (cluster of differentiation 4) cells containing Type 1 regulatory T (Tr1) cells induced in vitro in the presence of IL-10 (interleukin-10), which are also defined as IL-10 anergized T cells. T-allo10 cell infusion is being developed to prevent acute Graft-versus-Host Disease (GvHD) and induce graft tolerance in patients with hematologic malignancies receiving mismatched related and unrelated unmanipulated hematopoietic stem cell transplant (HSCT).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive 1 X 10^6/kg (± 10%) T-allo10 cells infused intravenously on Day -1 (day before transplant) Receives: Biological: T-allo10 |
| Cohort 2 | Experimental | Participants will receive 3 X 10^6/kg (± 10%) T-allo10 cells infused intravenously on Day -1 (day before transplant) Receives: Biological: T-allo10 |
| Cohort 3 | Experimental | Participants will receive 9 X 10^6/kg (± 10%) T-allo10 cells infused intravenously on Day -1 (day before transplant) Receives: Biological: T-allo10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)
Number of participants experiencing TEAEs. Assessments of TEAE will include laboratory abnormalities, changes in vital signs, and changes in physical examination related to the infusion of T-allo10 cells in order to assess the tolerability of T-allo10.
Measured: Time of T-allo10 cell infusion until 28 days following the infusion.
Severity of Treatment Emergent Adverse Events (TEAE)
Number of participants experiencing TEAEs related to infusion, by severity graded according to the CTCAE grading system, from grade 1 (least severe) to grade 5 (death). Assessments of TEAE will include laboratory abnormalities, changes in vital signs, and changes in physical examination following infusion of T-allo10 cells in order to assess the safety of T-allo10.
Measured: Time of T-allo10 cell infusion until 28 days following the infusion.
Number of Participants Who Achieved Stem Cell Engraftment After Hematopoietic Stem Cell Transplant (HSCT).
Stem cell engraftment is evaluated by clinical laboratory studies including absolute neutrophil count above 500/mm3 for three consecutive days, hematopoiesis at bone marrow examination, with cellularity >5 % and donor chimerism >90% by short tandem repeat (STR) analysis for the presence of donor cells, and minimal residual disease (MRD) assay < 0.1%.
Measured: +42 days post HSCT
Number of Successful T-allo10 Products Manufactured for Patients Enrolled
Feasibility defined by the rate of successful manufacture of the T-allo10 product to satisfy the targeted dose level and meet the required release specifications. Number of products meeting specifications out of total products manufactured is reported.
Measured: By Day -2
Secondary outcomes (1)
Number of Participants Who Experienced Grade III and/or IV Acute GvHD
The number of patients who experienced grade III and IV acute GvHD at Day +100 following infusion of Tallo10 cells, assessed using the Modified Keystone scale administered by an independent evaluator on study visits through Day +100
Measured: Study visits through Day +100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start30 Aug 2017
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Why it stopped: Lack of Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AML - Acute Myeloid 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roncarolo, Maria Grazia, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Rajni Agarwal, Stanford University
- Investigators
- Rajni Agarwal, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198234
- Sponsor's protocol ID
- IRB-38734
- Other IDs
- PEDSBMT297, 5P01CA049605-30
- Acronym
- T-allo10
- Status last verified
- Jul 2024
- First submitted
- 11 Apr 2017
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of T-allo10 Cell Infusions Combined With Mismatched Related or Mismatched Unrelated Hematopoietic Stem Cell Transplantation (HSCT) for Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT03198234
- Acronym / sponsor ID
- T-allo10 / IRB-38734
- Conditions
- AML - Acute Myeloid Leukemia, MDS (Myelodysplastic Syndrome), Mixed Phenotype Acute Leukemia, NHL - Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, ALL
- Keywords
- Pediatric, GvHD, Hematopoietic Stem Cell Transplantation, Stem Cells, Transplant, BMT - bone marrow transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Roncarolo, Maria Grazia, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Posted 18 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A significant number of patients with hematologic malignancies need a hematopoietic stem cell transplant (HSCT) to be cured. Only about 50% of these patients have a fully matched donor, the remaining patients will require an HSCT from a mismatched related or unrelated donor. Almost 60% of these mismatched donor HSCTs will result in graft-versus-host disease (GvHD), which can cause significant morbidity and increased non-relapse mortality. GvHD is caused by the donor effector T cells present in the HSC graft that recognize and react against the mismatched patient's tissues.
Researchers and physicians at Lucile Packard Children's Hospital, Stanford are working to prevent GvHD after HSCT with a new clinical trial. The objective of this clinical program is to develop a cell therapy to prevent GvHD and induce graft tolerance in patients receiving mismatched unmanipulated donor HSCT. The cell therapy consists of a cell preparation from the same donor of the HSCT (T-allo10) containing T regulatory type 1 (Tr1) cells able to suppress allogenic (host-specific) responses, thus decreasing the incidence of GvHD.
This is the first trial of its kind in pediatric patients and is only available at Lucile Packard Children's Hospital, Stanford.
The purpose of this phase 1 study is to determine the safety and tolerability of a cell therapy, T-allo10, to prevent GvHD in patients receiving mismatched related or mismatched unrelated unmanipulated donor HSCT for hematologic malignancies.
Detailed description
Patients ages 3-30 years, with hematologic malignancies undergoing mismatched related or unrelated donor transplant will receive conditioning chemotherapy with Total body radiation and cyclophosphamide, according to the standard procedure.
The investigators plan to infuse the donor T-allo10 product one day before HSCT so that the Tr1 cells contained within the T-allo10 product will be able to prevent anti-host alloreactivity of the T cells present within the unmanipulated HSC graft. Indeed, Tr1 cells best exert their suppressive activity at the time of effector T cell activation, occurring when the T cells present in the HSC graft will be transferred to the patient ; therefore, the investigators expect that the early infusion of T-allo10 cells will optimally modulate anti-host alloreactivity of the donor T cells and prevent GvHD.
Immunosuppression will also be administered at the time of HSCT.
Up to 27 eligible patients will be given the T-allo10 product sequentially in 3 escalating dose cohorts to determine the maximum tolerated dose (or the highest dose tested if no maximum tolerated dose is reached). Each cohort will begin by evaluating 3 patients. The patients in each cohort will be staggered by 28 days and each succeeding patient will be enrolled no sooner than the 29 day after the preceding patient's infusion of T-allo10.
- If no patient in a cohort develops a dose limiting toxicity (DLT) following infusion of the investigational cellular product, the investigators will start enrolling patients at the next higher cell dose after completing the 28-day safety evaluation of the 3rd patient in the dose cohort.
- If one out of 3 patients in a cohort has a DLT, 3 additional patients will be evaluated at the same dose level.
- If one out of 6 patients experiences a DLT, dose escalation will occur.
- If 2 out of ≤ 6 patients experience a DLT, dose escalation will cease and that dose will be designated the maximally administered dose.
- Up to three (3) additional patients will be entered at the next lowest dose level if only 3 patients were treated previously at that dose
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: T-allo10Participants will receive 1 X 10^6/kg (± 10%) T-allo10 cells infused intravenously on Day -1 (day before transplant) |
| Cohort 2 | Experimental | Biological: T-allo10Participants will receive 3 X 10^6/kg (± 10%) T-allo10 cells infused intravenously on Day -1 (day before transplant) |
| Cohort 3 | Experimental | Biological: T-allo10Participants will receive 9 X 10^6/kg (± 10%) T-allo10 cells infused intravenously on Day -1 (day before transplant) |
Who may qualify
- Ages
- 3 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (34 listed)
- Eligible diseases include:
- Age ≥3 to ≤45 years old. Subjects 1 and 2 (in Cohort 1) will be ≥ 12 years old
- Available mismatched related donor (mMRD) or mismatched unrelated donor (mMUD), Human leukocyte antigen (HLA) matched 8/10 or 9/10
- Lansky (age <16) or Karnofsky (age ≥16) performance status ≥80%
- Able and willing to provide written, signed informed consent (assent as appropriate)
Key exclusion criteria (10 listed)
- Prior bone marrow or peripheral blood HSCT within the last 6 (six) months
- HLA-matched related or unrelated donor available
- Any active, uncontrolled infection at the time of enrollment
- Pregnant or lactating females
- Any severe concurrent disease which, in the judgement of the investigator, would place the patient at increased risk during participation in the study
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 |
|---|---|---|
| T-allo10The T-allo10 drug product consists of donor derived, host (patient) alloantigen hyporesponsive (anergic) CD4+ (cluster of differentiation 4) cells containing Type 1 regulatory T (Tr1) cells induced in vitro in the presence of IL-10 (interleukin-10), which are also defined as IL-10 anergized T cells. T-allo10 cell infusion is being developed to prevent acute Graft-versus-Host Disease (GvHD) and induce graft tolerance in patients with hematologic malignancies receiving mismatched related and unrelated unmanipulated hematopoietic stem cell transplant (HSCT). | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)
Time frame: Time of T-allo10 cell infusion until 28 days following the infusion.
Number of participants experiencing TEAEs. Assessments of TEAE will include laboratory abnormalities, changes in vital signs, and changes in physical examination related to the infusion of T-allo10 cells in order to assess the tolerability of T-allo10.
Severity of Treatment Emergent Adverse Events (TEAE)
Time frame: Time of T-allo10 cell infusion until 28 days following the infusion.
Number of participants experiencing TEAEs related to infusion, by severity graded according to the CTCAE grading system, from grade 1 (least severe) to grade 5 (death). Assessments of TEAE will include laboratory abnormalities, changes in vital signs, and changes in physical examination following infusion of T-allo10 cells in order to assess the safety of T-allo10.
Number of Participants Who Achieved Stem Cell Engraftment After Hematopoietic Stem Cell Transplant (HSCT).
Time frame: +42 days post HSCT
Stem cell engraftment is evaluated by clinical laboratory studies including absolute neutrophil count above 500/mm3 for three consecutive days, hematopoiesis at bone marrow examination, with cellularity >5 % and donor chimerism >90% by short tandem repeat (STR) analysis for the presence of donor cells, and minimal residual disease (MRD) assay < 0.1%.
Number of Successful T-allo10 Products Manufactured for Patients Enrolled
Time frame: By Day -2
Feasibility defined by the rate of successful manufacture of the T-allo10 product to satisfy the targeted dose level and meet the required release specifications. Number of products meeting specifications out of total products manufactured is reported.
1 secondary outcome
Number of Participants Who Experienced Grade III and/or IV Acute GvHD
Time frame: Study visits through Day +100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share the individual participant data.
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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.
Rajni Agarwal, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T-allo10 in people with AML - Acute Myeloid Leukemia and MDS (Myelodysplastic Syndrome), run by Roncarolo, Maria Grazia, MD at 1 site 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 34 inclusion and 10 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: stopped early, as of the sponsor's last update on 18 Jul 2024. 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 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?
Yes. Results are posted in the registry (first posted 18 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) (time frame: Time of T-allo10 cell infusion until 28 days following the infusion.). 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 18 Jul 2024.