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Early phase study to evaluate the safety and efficacy of SMART101 to improve transplantation in blood cancers
EU CTIS ID: 2024-517953-28-00
What this study is testing
Segment 1: To determine the SMART101 recommended dose (RecD) Segment 2: - Safety: To evaluate the safety of SMART101 in term of unacceptable toxicity in the SMART101 arm - Efficacy: To evaluate the activity of SMART101 in term of CD4+ T-cell reconstitution
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients and Donors written informed consents. Patients must have voluntarily signed the written informed consent (ICF) before performance of any study-related inclusion procedures. Donors must have voluntarily signed the written ICF before the apheresis donation.
- Patients with AML, ALL or MDS eligible for an allogeneic HSCT with a HLA-mismatched donor (haploidentical or 9/10 matched unrelated donor, MUD) with post-transplant cyclophosphamide. In case of ≥ 5% bone marrow blasts, the investigator must contact the Sponsor for review and final eligibility decision.
- 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
You likely can't join if
- Patients who have received prior allogeneic stem cell transplantation
- Any abnormal condition or laboratory result that may alter patient’s condition or study outcome according to the Investigator’s judgement
- Patients with a history of allergic reactions or hypersensitivity attributed to the excipients of SMART101 (dimethyl sulfoxide [DMSO])
- Patients with a contraindication, including allergic reactions or hypersensitivity, to any medication as proposed per protocol or used as standard of care according to institutional standards of each participating stud site during the whole study
- 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
See the full eligibility criteria
Who can join
- Patients and Donors written informed consents. Patients must have voluntarily signed the written informed consent (ICF) before performance of any study-related inclusion procedures. Donors must have voluntarily signed the written ICF before the apheresis donation.
- Patients with AML, ALL or MDS eligible for an allogeneic HSCT with a HLA-mismatched donor (haploidentical or 9/10 matched unrelated donor, MUD) with post-transplant cyclophosphamide. In case of ≥ 5% bone marrow blasts, the investigator must contact the Sponsor for review and final eligibility decision.
- 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 and defined as: Bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert’s Syndrome, hemolysis or transfusion dependence; AST and ALT ≤ 2.5 x ULN; Alkaline phosphatase < 5 x ULN; Serum creatinine < 1.5 × ULN or creatinine clearance ≥ 60 mL/min (Cockcroft and Gault) for serum creatinine ≥ 1.5x ULN
- Women of childbearing potential must: have a negative pregnancy test; sexually active women must agree to use an effective method of birth control with their male partner (combined hormonal contraception or progesterone-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD) intrauterine hormone-releasing system (IUS) bilateral tubal occlusion, vasectomy or sexual abstinence) consistently and correctly for at least 1 year after the last administration of cyclophosphamide; agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction for at least 1 year after the last administration of cyclophosphamide; agree to no plan to breastfeed for at least 100 days after the infusion of SMART101 and no plan to become pregnant for at least 1 year after the last administration of cyclophosphamide
- Males who are sexually active must: agree to use an effective method of birth control with their partner of childbearing potential (combined hormonal contraception or progesterone-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS) bilateral tubal occlusion, vasectomy or sexual abstinence) consistently and correctly for at least 6 months after the last administration of cyclophosphamide or 1 year after the last administration of Thiotepa if applicable; agree to not donate sperm for at least 6 months after the last administration of cyclophosphamide or 1 year after the last administration of Thiotepa if applicable; no plan to father a child within 6 months after the last administration of cyclophosphamide or 1 year after the last administration of Thiotepa if applicable
What rules you out
- Patients who have received prior allogeneic stem cell transplantation
- Any abnormal condition or laboratory result that may alter patient’s condition or study outcome according to the Investigator’s judgement
- Patients with a history of allergic reactions or hypersensitivity attributed to the excipients of SMART101 (dimethyl sulfoxide [DMSO])
- Patients with a contraindication, including allergic reactions or hypersensitivity, to any medication as proposed per protocol or used as standard of care according to institutional standards of each participating stud site during the whole study
- 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
- Patients who have uncontrolled infection
- Patients with a documented history of human immunodeficiency virus (HIV) or human T-cell leukemia virus type 1 (HTLV-1), diagnosed by antibody assays or found positive following the serology testing scheduled at screening
- Patients with a documented Hepatitis B or hepatitis C infection with measurable viral load
- Patients with a known liver cirrhosis
- Patients with a confirmed tumor involvement in the central nervous system (CNS)
- Patients with psychiatric/social situations or addictive disorders, including active alcohol, that may compromise the ability of the patients to give informed consent or to comply with the study procedures (according to the Investigator’s judgement)
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.