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CAR T-cell Therapy

Stem Cell + CAR T-Cell Therapy for Blood Cancers

Phase 1

Recruiting

Research Sponsored by Joshua Sasine, MD, PhD

Eligibility Criteria Checklist

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

Must have

Relapsed or refractory disease, defined by disease progression after last regimen, or refractory disease: failure to achieve a partial response (PR) or complete remission (CR) to the last regimen

Subjects with an active uncontrolled infection should not start CAR T treatment until the infection has resolved

Must not have

Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management at time of screening

Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 0 to day 60.

Awards & highlights

No Placebo-Only Group

Summary

This trial studies combining stem cells from the patient's body with CAR T-cell therapy to treat relapsed/refractory hematologic diseases. It will assess safety and feasibility of collecting stem cells and evaluate response to treatment.

Who is the study for?

Adults aged 18-85 with certain blood cancers that have come back or haven't responded to treatment can join. They must be healthy enough for the procedure, not have had recent heart issues or transplants, and can't be pregnant or breastfeeding. Participants need to agree to birth control use and follow study procedures.

What is being tested?

The trial is testing if it's possible and safe to collect a person's own stem cells and add them to CAR T-cell therapy in patients whose blood cancer has returned after treatment or hasn’t improved. It will track how well this works in 20 people over the first two months by looking at side effects like CRS and ICANS.

What are the potential side effects?

Possible side effects include cytokine release syndrome (CRS), which can cause fever, nausea, headache, rash, rapid heartbeat; immune effector cell-associated neurotoxicity syndrome (ICANS), which may lead to confusion, difficulty speaking or understanding speech; as well as other common adverse events from treatments.

Eligibility Criteria

Inclusion Criteria

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

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My condition worsened after the last treatment or didn't improve significantly.

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I do not have any ongoing infections.

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My blood cancer is recognized by WHO and treatable with approved CAR T therapy.

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I am between 18 and 85 years old.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

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

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I currently have or might have an infection that isn't under control or needs IV drugs.

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I have not received a live vaccine in the last 6 weeks.

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I do not have abnormal blood cell growth detected in my bone marrow.

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I haven't taken high doses of steroids or immunosuppressants recently.

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I have a history of seizures, stroke, dementia, or autoimmune disease affecting my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 0 to day 60.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 0 to day 60.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 0 to day 60. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To assess feasibility of collecting the target HSC cell dose for at least 50% of enrolled patients.

To assess safety of aHSC to planned CAR T therapy in the first 60 days through the incidence, severity, and duration of CRS based on the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading system.

To assess safety of aHSC to planned CAR T therapy in the first 60 days through the incidence, severity, and duration of ICANS based on the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading system.

Secondary study objectives

Assess platelet count and transfusion independence rate by Day 28.

Assess rate of recovery of absolute neutrophil count (ANC) by Day 28.

Assess red blood cell (RBC) count and transfusion independence by Day 28.

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