Clinical trial NCT05350163: T-cell Receptor α/β Depleted Donor Lymphocyte Infusion
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoid Leukemia, Acute
Myeloid Malignancy
Plasma Cell Tumor
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The model is both parallel and sequential, in that Matched and Mismatched strata run in parallel and independently. Within each stratum, Cohorts I-III are filled sequentially. In addition, Cohort I of each stratum has three groups (A-C) that are filled sequentially.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs)
timeFrame: 30 days post-infusion
Secondary outcomes:
measure: Number of Participants in Remission
timeFrame: 2 years
measure: Number of Participants With Transplant-associated Viral Complications
timeFrame: 2 years
measure: Disease Free Survival- Measured by Absence of Relapse/Recurrence or Death.
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health, Inc
state: Florida
Study officials:
affiliation: Miami Cancer Institute
name: Guenther Koehne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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