Hematological MalignanciesPhase 1/2NCT05768035
Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide
A Phase 1/2 study testing Allogeneic T cell progenitors, cultured ex-vivo in people with Hematological Malignancies, run by Smart Immune SAS at 4 sites in France.
Trial summary
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitors (HTLP)) injection to accelerate immune reconstitution after haploidentical hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PT-Cy) in adult patients with hematological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Allogeneic T cell progenitors, cultured ex-vivo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Jun 2023to Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Patients with AML, ALL or MDS eligible for an allogeneic HSCT with a haploidentical donor with post-transplant cyclophosphamide.
- Patients must be ≥ 18 years of age at the time of signing the ICF.
- Patients must have a Karnofsky index ≥ 70%.
- Patients must have a left ventricular ejection fraction of ≥40%.
- Patients must have an intact pulmonary function or Diffusing capacity of the Lungs for Carbon Monoxide (DLCO) ≥ 45% of predicted.
- Patients must have adequate hepatic and renal functions, as assessed by standard laboratory criteria.
Main Exclusion Criteria:
- Patients who have received prior allogeneic stem cell transplantation.
- Patients who have received prior treatment with another cellular therapy within 4 weeks before the planned day of SMART101 infusion.
- Patients who plan to receive, are concurrently receiving or have received any investigational agent within 4 weeks before the planned day of SMART101 infusion.
Trial locations and contacts
4 sites in 1 country.
Aurélie BAUQUET, PhD contact
France4 sites, 4 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
Raynier Devillier, Pr
- Recruiting
Centre hospitalier universitaire de Nantes
Nantes, 44093
Patrice Chevallier, MD, PhD
- Recruiting
Hôpital Saint-Louis
Paris, 75010
Régis Peffault de Latour, Pr
- Recruiting
CHU Toulouse- Institut Universitaire du cancer Toulouse- Oncopole
Toulouse, 31059
Anne Huynh, MD
About this study
Official title: An Open-label, Multi-center Phase I/II Study to Assess the Safety and the Efficacy of SMART101 After Haploidentical Peripheral Blood Stem Transplantation With Post-transplant Cyclophosphamide in Subjects With Hematological Malignancies
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitors (HTLP)) injection to accelerate immune reconstitution after haploidentical hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PT-Cy) in adult patients with hematological malignancies.
- Conditions
- Hematological Malignancies
- Being tested
- Allogeneic T cell progenitors, cultured ex-vivo
- Keywords
- AML, ALL, MSD
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Myeloid, Acute, Multiple Sulfatase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic T cell progenitors, cultured ex-vivoBiological
Also called SMART101
Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute leukemia or myelodysplastic syndrome and eligible for an haplo PT-Cy HSCT | Experimental | Segment 1: 3 dose-level SMART101 cells/infusion
1. 1.5 x 106 CD7+ cells per kg of body weight
2. 4.5 x 106 CD7+ cells per kg of body weight
3. 9.0 x 106 CD7+ cells per kg of body weight
Segment 2:
2 cohorts of patients will be included in the study based on the type of conditioning regimen:
* The cohort A will include up to 17 patients receiving a myeloablative conditioning (MAC).
* The cohort B will include up to 17 patients receiving a reduced intensity conditioning (RIC).
* Enrollment of patients in each cohort will be done in parallel. Receives: Biological: Allogeneic T cell progenitors, cultured ex-vivo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Unexpected Unacceptable Toxicities (UUT) following the administration of SMART101.
To evaluate the safety of SMART101.
Measured: 14 days post SMART101 infusion
CD4+ T cell count.
to evaluate the efficacy of the study drug
Measured: 100 days post-HSCT
Secondary outcomes (4)
Occurrence of adverse events (AEs)
Measured: up to 24 months post-HSCT
T cell immune reconstitution
Time course of the T cell immune reconstitution, with a focus on naive CD4+ cells and total CD8+cells
Measured: up to 12 months post-HSCT
Cumulative incidence of infections
Measured: Day 100, and Months 6 and 12 post-HSCT
Non-relapse mortality (NRM)
Measured: Day 100, and Months 6, 12 and 24 post-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start6 Jun 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies 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
- Sequential
- Model description
- * Phase I/II, open-label, dose-escalation, single arm, multicenter study. * This study will comprise two segments: * A phase I dose-escalation segment: Three (3) prespecified dose-levels of SMART101 will be evaluated in three consecutive cohorts of patients whatever the type of conditioning regimen the patients will receive before the HSCT to define the SMART101 recommended dose (RecD). * A phase II segment: once all patients from the dose-escalation segment have completed their "treatment period " and the SMART101 RecD has been defined, a total number of 34 patients will be enrolled at the RecD in the phase II segment of the study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smart Immune SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabio CICERI, MD, Pr., Principal investigator, I.R.C.C.S. Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768035
- Sponsor's protocol ID
- SI101-02
- Status last verified
- Sep 2023
- First submitted
- 2 Mar 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Phase I/II Study to Assess the Safety and the Efficacy of SMART101 After Haploidentical Peripheral Blood Stem Transplantation With Post-transplant Cyclophosphamide in Subjects With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05768035
- Acronym / sponsor ID
- SI101-02
- Conditions
- Hematological Malignancies
- Keywords
- AML, ALL, MSD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Smart Immune SASIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 14 Mar 2023 (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.
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitors (HTLP)) injection to accelerate immune reconstitution after haploidentical hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PT-Cy) in adult patients with hematological malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Phase I/II, open-label, dose-escalation, single arm, multicenter study. * This study will comprise two segments: * A phase I dose-escalation segment: Three (3) prespecified dose-levels of SMART101 will be evaluated in three consecutive cohorts of patients whatever the type of conditioning regimen the patients will receive before the HSCT to define the SMART101 recommended dose (RecD). * A phase II segment: once all patients from the dose-escalation segment have completed their "treatment period " and the SMART101 RecD has been defined, a total number of 34 patients will be enrolled at the RecD in the phase II segment of the study.
| Arm | Type | Receives |
|---|---|---|
| Patients with acute leukemia or myelodysplastic syndrome and eligible for an haplo PT-Cy HSCT | Experimental | Biological: Allogeneic T cell progenitors, cultured ex-vivoSegment 1: 3 dose-level SMART101 cells/infusion 1. 1.5 x 106 CD7+ cells per kg of body weight 2. 4.5 x 106 CD7+ cells per kg of body weight 3. 9.0 x 106 CD7+ cells per kg of body weight Segment 2: 2 cohorts of patients will be included in the study based on the type of conditioning regimen: * The cohort A will include up to 17 patients receiving a myeloablative conditioning (MAC). * The cohort B will include up to 17 patients receiving a reduced intensity conditioning (RIC). * Enrollment of patients in each cohort will be done in parallel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Allogeneic T cell progenitors, cultured ex-vivoAlso: SMART101Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide | Biological | Patients with acute leukemia or myelodysplastic syndrome and eligible for an haplo PT-Cy HSCT |
Primary outcome
Occurrence of Unexpected Unacceptable Toxicities (UUT) following the administration of SMART101.
Time frame: 14 days post SMART101 infusion
To evaluate the safety of SMART101.
CD4+ T cell count.
Time frame: 100 days post-HSCT
to evaluate the efficacy of the study drug
4 secondary outcomes
Occurrence of adverse events (AEs)
Time frame: up to 24 months post-HSCT
T cell immune reconstitution
Time frame: up to 12 months post-HSCT
Cumulative incidence of infections
Time frame: Day 100, and Months 6 and 12 post-HSCT
Non-relapse mortality (NRM)
Time frame: Day 100, and Months 6, 12 and 24 post-HSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- 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.
Aurélie BAUQUET, PhD contact
Fabio CICERI, MD, Pr. principal investigator
I.R.C.C.S. Ospedale San Raffaele
4 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 Allogeneic T cell progenitors, cultured ex-vivo in people with Hematological Malignancies, run by Smart Immune SAS at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 Frédéric LEHMANN, MD (+32 (0) 492 46 23 55, frederic.lehmann@smart-immune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Unexpected Unacceptable Toxicities (UUT) following the administration of SMART101. (time frame: 14 days post SMART101 infusion). The study lists 2 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 25 Sep 2023.