T-cell Receptor α/β Depleted Donor Lymphocyte Infusion

Sponsor

Baptist Health South Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT05350163

Collaborator

(none)

Enrollment

Location

Arms

71.9

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoid Leukemia, Acute Myeloid Malignancy Plasma Cell Tumor	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 5, 2022

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Apr 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HLA Matched Cohort 1 5 x 105/kg at 6-7, 4-5 and 2-3 weeks post-transplant	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
Experimental: HLA Matched Cohort 2 5 x 105/kg starting time point X, 1 x 1 06/kg 3-4 weeks after first dose, 1 x 106/kg 3-4 weeks after second dose	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
Experimental: HLA Matched Cohort 3 5 x 105/kg starting time point X, 1 x 1 06/kg 3-4 weeks after first dose, 3 x 106/kg 3-4 weeks after second dose	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
Experimental: HLA Mismatched Cohort 1 1 x 105/kg at 6-7, 4-5 and 2-3 weeks post-transplant	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
Experimental: HLA Mismatched Cohort 2 1 x 105/kg starting time point X, 5 x 1 05/kg 3-4 weeks after first dose, 5 x 105/kg 3-4 weeks after second dose	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
Experimental: HLA Mismatched Cohort 3 1 x 105/kg starting time point X, 5 x 1 05/kg 3-4 weeks after first dose, 1 x 106/kg 3-4 weeks after second dose	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

Outcome Measures

Primary Outcome Measures

Incidence of treatment - emergent adverse events [2 years]
Emergent adverse events include adverse events, serious adverse events, laboratory abnormalities, incidence of subjects experiencing dose modifications, dose interruptions, and/or premature discontinuation.
Number of participants with transplant-associated viral complications [2 years]
Transplant-associated viral complications - measured by viral infections associated with transplant
Number of participants in remission [2 years]
Remission - measured by absence of signs and symptoms
Disease free survival- measured by absence of relapse/recurrence or death. [2 years]
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.
Overall survival - measured by death [2 years]
Overall survival - measured by death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with hematologic malignancies that are candidates CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation
Patient's age includes >18 to < 75 years old.
Patients may be of either gender or any ethnic background.
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 LVEF at rest must be 50% and must improve with exercise.

Hepatic: < 3x ULN AST and: s 1.5 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: s; 1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl > 40 ml/m in (measured or calculated/estimated).

Pulmonary: asymptomatic or if symptomatic, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miami Cancer Institute at Baptist Health, Inc	Miami	Florida	United States	33176

Sponsors and Collaborators

Baptist Health South Florida

Investigators

Principal Investigator: Guenther Koehne, MD, PhD, Miami Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Miami Cancer Institute Website

Publications

Responsible Party:

Baptist Health South Florida

ClinicalTrials.gov Identifier:

NCT05350163

Other Study ID Numbers:

2019-KOE-004

First Posted:

Apr 28, 2022

Last Update Posted:

May 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Leukemia, Lymphoid

Plasmacytoma

Neoplasms, Plasma Cell

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of May 27, 2022