Clinical trial NCT06225050: M-2018-334 in Hematological Malignancies
Official title: A Single-center Pilot Study Using TCRα/β and CD45RA Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation in Adults(HAPLO2022)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hematological Malignancies
Lead sponsor: Miltenyi Biomedicine GmbH
Sponsor class: INDUSTRY
Collaborators: name: City of Hope Comprehensive Cancer Center
First posted: 2024-01-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, open-label, single-arm, pilot clinical study using TCRα/β and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.


Eligibility criteria: Inclusion Criteria:

* Patients, between 18 years to 75 years of age, with high-risk hematological malignancy requiring an allogeneic hematopoietic stem cell transplantation (AlloHCT), but do not have an HLA-matched donor available

Exclusion Criteria:

* \<3 months after preceding autologous transplantation or prior AlloHCT
* History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active CNS infection)
* Active fungal infections with radiological and clinical progression
* Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher than 400 U/L
* Chronic active viral hepatitis
* Cardiac dysfunction: adult patients ejection fraction \<50% on echocardiography
* Patients with uncontrolled, \>grade II hypertension (per Common Toxicity Criteria, CTC)
* Creatinine clearance \<60 mL/min/1.73m2
* Respiratory failure necessitating supplemental oxygen
* HIV infection
* Positive anti-donor HLA antibody
* Treatment with checkpoint inhibitors in the period between 3 months prior to and 3 months after transplantation
* Female patients who are pregnant or breast feeding, or adults of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter. Note: Women of childbearing potential must have a negative serum pregnancy test at study entry
* Concurrent severe or uncontrolled medical disease (e.g., uncontrolled diabetes, myocardial infarction within 6 months prior to the study) which by assessment of the treating physician could compromise participation in the study
* Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction).
* Patients unwilling or unable to comply with the protocol or unable to give informed consent
* Treatment with any investigational product within 4 weeks prior to study treatment

Primary outcomes:
measure: Incidence of severe acute GVHD (aGVHD) till Day 100
timeFrame: 100 days after haploidentical hematopoietic cell transplantation
Secondary outcomes:
measure: Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA(Trial Version)
timeFrame: Until Last Patient Last Visit(24 Months)
measure: Incidence of acute GVHD (aGVHD) till six months post-transplantation
timeFrame: 6 Months
measure: Neutrophil Engraftment
timeFrame: Day 7
measure: Platelet Engraftment
timeFrame: Day 0
measure: Chronic GVHD
timeFrame: 1 Year
measure: Non-relapse mortality (NRM)
timeFrame: Until Last patient last Visit(24 Months)
measure: Infusion toxicity
timeFrame: 15 minutes, 30 minutes, 2 hours, and 4 hours post infusion
measure: Graft failure
timeFrame: 30 Days
measure: Overall survival (OS)
timeFrame: Day 100 and through study completion, an average of 1 year post transplantation
measure: Disease-free survival (DFS)
timeFrame: Day 100 and through study completion, an average of 1 year post transplantation
measure: GVHD/relapse-free survival (GRFS)
timeFrame: GRFS will be assessed at Month 12 post transplantation
measure: Immunosuppression-free survival (ISFS)
timeFrame: Assessed at 1 year with a starting point at Day 45 post-transplantation
measure: Relapse rate
timeFrame: 12 Months
measure: Hospitalization length/re-admission
timeFrame: Assessed at Day 30, Day 100 and at 12 Months post transplantation
Other outcomes:
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