HLA Mismatched Cohort 2 for Plasma Cell Tumor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Miami Cancer Institute at Baptist Health, Inc, Miami, FL
Plasma Cell Tumor+7 More
T-cell Receptor α/β Depleted Donor Lymphocyte Infusions - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Plasma Cell Tumor
  • Lymphoid Leukemia, Acute
  • Myeloid Malignancy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

10 Primary · 0 Secondary · Reporting Duration: 2 years

2 years
Disease free survival
Disease free survival- measured by absence of relapse/recurrence or death.
Incidence of treatment - emergent adverse events
Number of participants in remission
Number of participants with transplant-associated viral complications
Overall survival
Overall survival - measured by death
Remission
Safety and tolerability
Transplant-associated viral complications

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

HLA Mismatched Cohort 2
1 of 6
HLA Mismatched Cohort 3
1 of 6
HLA Matched Cohort 2
1 of 6
HLA Matched Cohort 3
1 of 6
HLA Mismatched Cohort 1
1 of 6
HLA Matched Cohort 1
1 of 6
Experimental Treatment

24 Total Participants · 6 Treatment Groups

Primary Treatment: HLA Mismatched Cohort 2 · No Placebo Group · Phase 1

HLA Mismatched Cohort 2
Biological
Experimental Group · 1 Intervention: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions · Intervention Types: Biological
HLA Mismatched Cohort 3
Biological
Experimental Group · 1 Intervention: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions · Intervention Types: Biological
HLA Matched Cohort 2
Biological
Experimental Group · 1 Intervention: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions · Intervention Types: Biological
HLA Matched Cohort 3
Biological
Experimental Group · 1 Intervention: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions · Intervention Types: Biological
HLA Mismatched Cohort 1
Biological
Experimental Group · 1 Intervention: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions · Intervention Types: Biological
HLA Matched Cohort 1
Biological
Experimental Group · 1 Intervention: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Closest Location: Miami Cancer Institute at Baptist Health, Inc · Miami, FL
Photo of Miami  1Photo of Miami  2Photo of Miami  3
2020First Recorded Clinical Trial
1 TrialsResearching Plasma Cell Tumor
1 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of either gender or any ethnic background.
Patients with a history of liver disease are eligible for treatment with Rituximab if they have elevated serum bilirubin levels and no evidence of active liver disease
Pulmonary: DLCO 50% of predicted (corrected for hemoglobin).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References