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T-cell Receptor α/β Depleted Donor Lymphocyte Infusion

Primary Purpose

Lymphoid Leukemia, Acute, Myeloid Malignancy, Plasma Cell Tumor

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

T-cell Receptor α/β Depleted Donor Lymphocyte Infusions

About this trial

This is an interventional treatment trial for Lymphoid Leukemia, Acute

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Miami Cancer Institute at Baptist Health, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

HLA Matched Cohort I

HLA Matched Cohort II

HLA Matched Cohort III

HLA Mismatched Cohort I

HLA Mismatched Cohort II

HLA Mismatched Cohort III

Arm Description

5 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)

5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose

5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 2 x 10^6/kg 3-4 weeks after second dose

1 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)

1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 5 x 10^5/kg 3-4 weeks after second dose

1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of participants in remission

Remission - measured by absence of signs and symptoms

Number of participants with transplant-associated viral complications

Transplant-associated viral complications - measured by viral infections associated with transplant

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.

Overall survival - measured by death

Full Information

NCT ID

NCT05350163

First Posted

April 22, 2022

Last Updated

October 6, 2023

Sponsor

Baptist Health South Florida

1. Study Identification

Unique Protocol Identification Number

NCT05350163

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 5, 2022 (Actual)

Primary Completion Date

April 1, 2026 (Anticipated)

Study Completion Date

April 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baptist Health South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoid Leukemia, Acute, Myeloid Malignancy, Plasma Cell Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HLA Matched Cohort I

Arm Type

Experimental

Arm Description

5 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)

Arm Title

HLA Matched Cohort II

Arm Type

Experimental

Arm Description

5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose

Arm Title

HLA Matched Cohort III

Arm Type

Experimental

Arm Description

5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 2 x 10^6/kg 3-4 weeks after second dose

Arm Title

HLA Mismatched Cohort I

Arm Type

Experimental

Arm Description

1 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)

Arm Title

HLA Mismatched Cohort II

Arm Type

Experimental

Arm Description

1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 5 x 10^5/kg 3-4 weeks after second dose

Arm Title

HLA Mismatched Cohort III

Arm Type

Experimental

Arm Description

1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose

Intervention Type

Biological

Intervention Name(s)

T-cell Receptor α/β Depleted Donor Lymphocyte Infusions

Intervention Description

T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent serious adverse events (TE-SAEs)

Description

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.

Time Frame

30 days post-infusion

Secondary Outcome Measure Information:

Title

Number of participants in remission

Description

Remission - measured by absence of signs and symptoms

Time Frame

2 years

Title

Number of participants with transplant-associated viral complications

Description

Transplant-associated viral complications - measured by viral infections associated with transplant

Time Frame

2 years

Title

Disease free survival- measured by absence of relapse/recurrence or death.

Description

Time Frame

2 years

Title

Overall survival - measured by death

Description

Overall survival - measured by death

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guenther Koehne, MD, PhD

Organizational Affiliation

Miami Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Miami Cancer Institute at Baptist Health, Inc

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Links:

URL

http://cancer.baptisthealth.net/miami-cancer-institute

Description

Miami Cancer Institute Website

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T-cell Receptor α/β Depleted Donor Lymphocyte Infusion

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