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CAR T-cell Therapy

Engineered T Cells for Blood Cancer (RESOLVE Trial)

Phase 1

Recruiting

Research Sponsored by Catherine Bollard

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 6 months to 80 years

T cell chimerism > 94% if collected from recipient of allo-HSCT within the last 6 months

Must not have

Uncontrolled infections

Active Bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if it is safe to give HSCT recipients T cells that have been engineered to kill tumor cells. It will also test if this treatment improves the six-month event-free survival rate for patients with high-risk AML or MDS.

Who is the study for?

This trial is for people aged 6 months to 80 years with certain high-risk blood cancers or tumors who have had, or will have, a stem cell transplant. They must be in relatively good health otherwise and agree to use contraception if applicable. Pregnant women, those with severe graft-versus-host disease (GVHD), uncontrolled infections, or recent treatment with certain immune therapies are excluded.

What is being tested?

The study tests TAA-T cells in patients receiving stem cell transplants for aggressive blood cancers. It's divided into three arms: A) post-transplant patients; B) pre-transplant patients; C) post-transplant without relapse. The goal is to see if these cells improve survival without the cancer returning after six months.

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as GVHD where the donor cells attack the patient’s body, infection risks due to weakened immunity from treatments, and typical infusion-related symptoms like fever or chills.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 months and 80 years old.

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My T cell chimerism is over 94% after a recent stem cell transplant.

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My lymphocyte count is 600 or higher for a self-donated cell therapy.

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I have high-risk AML or MDS and had a stem cell transplant without my cancer returning.

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I have had or will have a stem cell transplant from a donor.

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I have a specific type of blood cancer with active disease.

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My lymphoma is currently active.

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I can do most activities but may need help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any infections that are not responding to treatment.

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I have active lung, skin, or serous membrane conditions.

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I have a history of cancer.

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I do not have any infections that are currently uncontrolled.

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I have severe graft-versus-host disease or related lung or skin conditions.

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I have had a condition where my lymphocytes multiply unusually.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of investigational product (TAA-T)

Secondary study objectives

Tumor associated antigen lymphocytes (TAA-T) responses

Other study objectives

Event free and overall survival

The incidence and severity of acute and/or chronic GVHD

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tumor associated antigen lymphocytes (TAA-T)Experimental Treatment1 Intervention

For Arm A Patients (post-HSCT): TAA-T will be infused any time after neutrophil engraftment post-HSCT or day 30, whichever comes first. For Arm B Patients (pre-HSCT): TAA-T will be infused any time \> 7 days after previous therapy for relapsed disease. For Arm C Patients (post-HSCT): TAA-T will be infused any time after neutrophil engraftment post-HSCT or day 30, whichever comes first. All infusions will be within 5 months post-HSCT. Five different dosing levels will be evaluated. Two to four patients will be evaluated on each dosing schedule (see below). This protocol is designed as a phase I dose-escalation study. Dose Level One: 5 x 106 cells/m2 Dose Level Two: 1 x 107 cells/m2 Dose Level Three: 2 x 107 cells/m2 Dose Level Four: 4 x 107 cells/m2 Dose Level Five: 1 x 108 cells/m2 (ONLY applicable to Arm A patients) Arm C patients will ONLY be enrolled at: Dose Level Four (4 x 107 cells/m2)

0 / 14Eligibility criteria met