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Allogeneic T Cell Therapy for Blood Cancers
Phase 1 & 2
Recruiting
Led By Jaap-Jan BOELENS, MD, PhD
Research Sponsored by Smart Immune SAS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Use of an HLA matched Cord Blood (8/8 allele matched) or haploidentical donor; Prior therapy with allogeneic stem cell transplantation; Treatment with another cellular therapy within one month before inclusion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 12 post-hsct
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a new treatment can help people with relapsed or refractory leukemia by increasing the speed of immune system recovery after a stem cell transplant.
Who is the study for?
This trial is for children and adults with blood cancers who need a stem cell transplant but don't have a perfect donor match. They should be in at least their second complete remission or have low levels of remaining cancer cells. Participants must be fit enough for the transplant, with good organ function and performance status.
What is being tested?
The study tests SMART101 injections to speed up immune recovery after a T-cell depleted stem cell transplant in patients with blood cancers. It aims to determine how safe and effective these cultured human T lymphoid progenitors are post-transplant.
What are the potential side effects?
While specific side effects aren't listed, potential risks may include reactions at the injection site, immune system complications, or issues related to rapid immune reconstitution following transplantation.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 12 post-hsct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 12 post-hsct
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CD4+ T cell count
Cumulative incidence of grade III-IV GvHD
Occurrence of adverse events related to SMART101
Secondary study objectives
T cell immune reconstitution
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pediatric patients affected by hematological malignanciesExperimental Treatment1 Intervention
Pediatric patients affected by acute leukemia (AML, ALL or acute leukemia of ambiguous lineage) eligible for a T depleted allogeneic HSCT
Group II: Adult patients affected by hematological malignanciesExperimental Treatment1 Intervention
Adult patients affected by acute leukemia (AML, ALL or acute leukemia of ambiguous lineage) or myelodysplastic syndrome eligible for a T depleted allogeneic HSCT
Find a Location
Who is running the clinical trial?
Smart Immune SASLead Sponsor
2 Previous Clinical Trials
54 Total Patients Enrolled
Jaap-Jan BOELENS, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center (MSKCC)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Adult patients affected by hematological malignancies
- Group 2: Pediatric patients affected by hematological malignancies
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.