T-cell Receptor α/β Depleted Donor Lymphocyte Infusion

Myeloid Malignancy Clinical Trial

Official title:

Phase I Dose Escalation of T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Following CD34+- Selected Allogeneic Stem Cell Transplantation From Related & Unrelated Donors in Patients With Lymphoid, Myeloid or Plasma Cell Malignancies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05350163
• Other study ID #: 2019-KOE-004
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 5, 2022
• Est. completion date: April 1, 2028

Study information

• Verified date: October 2023
• Source: Baptist Health South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a T-cell depleted allogeneic hematopoietic cell transplantation (TCD HSCT).

This study is designed to see whether an investigational cellular product of immune cells obtained from a donor's cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered. These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status, infectious complication, progression-free and overall survival.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• 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%.

• Patients must have adequate organ function measured by:

• Cardiac: asymptomatic or if symptomatic then left ventricular ejection fraction (LVEF) at rest must be 50% and must improve with exercise.

• Hepatic: < 3x upper limit of normal (ULN) AST and < 1.5 mg/dL total serum bilirubin, unless there is congenital benign hyperbilirubinemia. Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval (e.g., patients with PNH, Gilbert's disease or other hemolytic disorders).

• Renal: serum creatinine: = 1.2 mg/dL or if serum creatinine is outside the normal range, then creatinine clearance (CrCl) > 40 mL/min (measured or calculated/estimated).

• Pulmonary: asymptomatic or if symptomatic, diffusing capacity of the lungs for carbon monoxide (DLCO) 50% of predicted (corrected for hemoglobin).

• Each patient must be willing to participate as a research subject and must sign an informed consent form.

Exclusion Criteria:

• Patients with active acute GvHD.

Related Conditions & MeSH terms

• Leukemia, Lymphoid
• Myeloid Malignancy
• Neoplasms
• Neoplasms, Plasma Cell
• Plasmacytoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• T-cell Receptor a/ß Depleted Donor Lymphocyte Infusions
T-cell Receptor a/ß Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

Locations

Country	Name	City	State
United States	Miami Cancer Institute at Baptist Health, Inc	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baptist Health South Florida

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent serious adverse events (TE-SAEs)	TE-SAEs are defined as the composite of death, non-fatal pulmonary embolism, stroke, acute graft versus host disease (GvHD), and clinically significant laboratory test abnormalities.	30 days post-infusion
Secondary	Number of participants in remission	Remission - measured by absence of signs and symptoms	2 years
Secondary	Number of participants with transplant-associated viral complications	Transplant-associated viral complications - measured by viral infections associated with transplant	2 years
Secondary	Disease free survival- measured by absence of relapse/recurrence or death.	Disease free survival - measured by (absence of ) relapse/recurrence or death.; Relapse and recurrence, both will be measured by greater than 5% circulating leukemic blasts in the marrow or peripheral blood and/or the presence of blasts in any extra medullary site and/or disease determined by clinical assessment.	2 years
Secondary	Overall survival - measured by death	Overall survival - measured by death	2 years

External Links

•   Miami Cancer Institute Website