TCRαβ+/CD19+ Depleted DLI for Blood Cancers

Overseen By Cancer Connect

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Poor organ function, Uncontrolled illness, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of a specialized treatment called TCRαβ+/CD19+ Depleted Donor Lymphocyte Infusion, a type of cell therapy, for individuals with high-risk blood cancers. The researchers will test different doses to identify the most tolerable one for patients. They seek participants with aggressive blood cancers, such as certain types of leukemia or lymphoma, who have undergone or will undergo a stem cell transplant from a relative. As an unphased trial, this study provides patients the chance to contribute to groundbreaking research that could lead to new treatment options.

What prior data suggests that TCRαβ+/CD19+ Depleted Donor Lymphocyte Infusion is safe for high-risk patients with hematologic malignancies?

Research has shown that a special type of Donor Lymphocyte Infusion (DLI) has been studied for its safety in patients who have undergone a stem cell transplant. This treatment helps the immune system fight blood cancers more effectively.

One study examined patient responses to this infusion and found that while some experienced side effects, they were generally manageable. These side effects might include fever or chills, common reactions to many types of infusions.

Another study focused on identifying the highest dose patients could tolerate without serious side effects, carefully adjusting doses to determine safety.

Since this treatment involves altering immune cells, safety is closely monitored. Ongoing research aims to ensure that any side effects are understood and managed properly.

In summary, while some side effects have been reported, the treatment is being adjusted to find the safest dose for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TCRαβ+/CD19+ Depleted Donor Lymphocyte Infusion because it represents a novel approach for treating blood cancers. Unlike traditional therapies like chemotherapy or stem cell transplants, this treatment involves a specialized donor lymphocyte infusion that is depleted of TCRαβ+ and CD19+ cells. This depletion is designed to reduce the risk of graft-versus-host disease, a common complication with donor-related therapies. By selectively infusing CD3-CD56+ cells, the treatment aims to enhance the anti-cancer immune response while minimizing harmful side effects.

What evidence suggests that TCRαβ+/CD19+ Depleted Donor Lymphocyte Infusion might be an effective treatment for blood cancers?

Research has shown that a special type of donor cell infusion, called TCRαβ+/CD19+ depleted DLI, may help treat blood cancers. In past studies, this treatment reduced the risk of graft-versus-host disease (GVHD), a common issue after stem cell transplants. Patients who received this infusion had similar survival rates and time without disease as those who underwent other transplant methods. The treatment removes certain immune cells that cause GVHD while preserving those that fight cancer. In this trial, participants will receive varying doses of this infusion to determine the safest and most effective dose. Early results suggest it might be a safer choice for high-risk patients after receiving stem cell transplants from a donor. ^{1 2 3 4 5}

Who Is on the Research Team?

Hongtao Liu, MD, PhD

Principal Investigator

UW Carbone Cancer Center

Jacques Galipeau, MD, FRCP(C)

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for high-risk patients with blood cancers who can understand and sign consent, have an ECOG score of 0-2, agree to use contraception if at risk of pregnancy, and have a suitable donor for stem cell transplant. It's not for those with psychiatric issues or poor organ function that could limit study compliance.

Inclusion Criteria

Ability to understand and willingness to sign written informed consent document

I can perform daily activities with minimal assistance.

Willingness to comply with all study procedures and be available for the duration of the study

Exclusion Criteria

Patients with psychiatric illness/social situations that would limit compliance with study requirements

Patients with uncontrolled intercurrent illness

My organ function is poor according to my pre-transplant tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive TCRαβ+/CD19+ depleted donor lymphocyte infusion (αβT/B dep-DLI) with dose escalation to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).

Up to 28 days post-DLI

Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and efficacy measures.

2 years

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• TCRαβ+/CD19+ Depleted Donor Lymphocyte Infusion

Trial Overview

The trial tests the safety and maximum tolerable dose of TCRαβ+/CD19+-depleted Donor Lymphocyte Infusion after allogeneic stem cell transplant in patients with high-risk hematologic malignancies to see how well they tolerate this post-transplant treatment.

How Is the Trial Designed?

Group I: Dose Escalation Cohort Level 3 Experimental Treatment 1 Intervention

5 X 10\^6 CD3-CD56+/kg

Group II: Dose Escalation Cohort Level 2 Experimental Treatment 1 Intervention

2 X 10\^6 CD3-CD56+/kg

Group III: Dose Escalation Cohort Level 1 Experimental Treatment 1 Intervention

1 x 10\^6 CD3-CD56+/kg

Group IV: Dose Escalation Cohort Level -1 Experimental Treatment 1 Intervention

0.5 x 10\^6 CD3-CD56+/kg Dose to be used only if Dose Level 1 is not tolerated.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07285668

Prophylactic TCRaB+ and CD19+ Depleted Donor ...

This study is being done to assess the safety and determine the maximum tolerable dose (MTD) of TCRαβ+/CD19+-depleted Donor Lymphocyte ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8702395/

Results of a multicenter phase I/II trial of TCRαβ and CD19- ...

Results of a multicenter phase I/II trial of TCRαβ and CD19-depleted haploidentical hematopoietic stem cell transplantation for adult and pediatric patients.

3.

clin.larvol.com

clin.larvol.com/trial-detail/NCT07285668

Prophylactic TCRaB+ and CD19+ Depleted Donor ...

To assess the effect of regulatory T cells on safety and efficacy of prophylactic αβT/B dep-DLI following allo-SCT in high-risk patients with hematologic ...

4.

ashpublications.org

ashpublications.org/blood/article/143/3/279/498045/TCR-CD19-cell-depleted-HLA-haploidentical

TCRαβ/CD19 cell–depleted HLA-haploidentical ...

TCRαβ/CD19 cell–depleted haploHSCT is characterized by low NRM and acute/chronic GVHD, with OS and DFS similar to other transplants.

5.

ctv.veeva.com

ctv.veeva.com/study/prophylactic-tcrab-and-cd19-depleted-donor-lymphocyte-infusion-after-allogeneic-stem-cell-transpla

Prophylactic TCRaB+ and CD19+ Depleted Donor ...

This study is being done to assess the safety and determine the maximum tolerable dose (MTD) of TCRαβ+/CD19+-depleted Donor Lymphocyte ...