M-2018-334 in Hematological Malignancies (HAPLO2022)

Miltenyi Biotec

Status: Begins enrollment this month

Conditions: Hematological Malignancies

Treatments: Device: CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06225050

M-2018-334

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

HSC Recipient

Experimental group

Description:

PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)

Treatment:

Device: CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)