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TCR α/β-Depleted DLI for Leukemia

Phase 1
Waitlist Available
Led By Guenther Koehne, MD, PhD
Research Sponsored by Baptist Health South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with hematologic malignancies that are candidates CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation
Patients must have a Karnofsky (adult) Performance Status of at least 70%
Must not have
Patients with active acute GvHD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is being conducted to study the safety and efficacy of an investigational cellular product in patients with lymphoid or myeloid malignancies who have undergone T-cell depleted allogeneic hematopoietic cell transplantation.

Who is the study for?
This trial is for adults aged 18-75 with certain blood cancers who've had a T-cell depleted stem cell transplant. They need to be fairly active (70% on Karnofsky scale), have good heart, liver, kidney, and lung function, and agree to participate in research.Check my eligibility
What is being tested?
The study tests if immune cells from donors, treated to remove ones causing graft vs host disease, can safely improve cancer outcomes post-transplant. It looks at the effect on residual disease, infection rates, and survival without cancer progression.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as fever or fatigue due to infusion of donor cells. There's also a risk of complications from graft versus host disease despite the depletion of specific T-cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for a specific stem cell transplant for my blood cancer.
Select...
I am mostly able to care for myself but cannot do any heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently experiencing active acute graft-versus-host disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent serious adverse events (TE-SAEs)
Secondary outcome measures
Disease free survival- measured by absence of relapse/recurrence or death.
Number of participants in remission
Number of participants with transplant-associated viral complications
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: HLA Mismatched Cohort IIIExperimental Treatment1 Intervention
1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose
Group II: HLA Mismatched Cohort IIExperimental Treatment1 Intervention
1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 5 x 10^5/kg 3-4 weeks after second dose
Group III: HLA Mismatched Cohort IExperimental Treatment1 Intervention
1 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)
Group IV: HLA Matched Cohort IIIExperimental Treatment1 Intervention
5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 2 x 10^6/kg 3-4 weeks after second dose
Group V: HLA Matched Cohort IIExperimental Treatment1 Intervention
5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose
Group VI: HLA Matched Cohort IExperimental Treatment1 Intervention
5 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)

Find a Location

Who is running the clinical trial?

Baptist Health South FloridaLead Sponsor
50 Previous Clinical Trials
7,868 Total Patients Enrolled
Guenther Koehne, MD, PhDPrincipal InvestigatorMiami Cancer Institute
3 Previous Clinical Trials
122 Total Patients Enrolled

Media Library

T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Clinical Trial Eligibility Overview. Trial Name: NCT05350163 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: HLA Matched Cohort I, HLA Matched Cohort II, HLA Matched Cohort III, HLA Mismatched Cohort I, HLA Mismatched Cohort II, HLA Mismatched Cohort III
Acute Lymphoblastic Leukemia Clinical Trial 2023: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Highlights & Side Effects. Trial Name: NCT05350163 — Phase 1
T-cell Receptor α/β Depleted Donor Lymphocyte Infusions 2023 Treatment Timeline for Medical Study. Trial Name: NCT05350163 — Phase 1
~5 spots leftby Apr 2026
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