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Chemotherapy

Orca-T and Radiation Therapy for Leukemia

Duarte, CA

Phase 1

Recruiting

Led By Amandeep Salhotra

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)

Age: 60-75 years

Must not have

Prior allogeneic stem cell transplant

More than 3 prior lines of intensive chemotherapy, where the regimen intent was to induce remission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of therapy to relapse/progression, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment for patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. The treatment involves using a targeted form of radiation therapy

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Who is the study for?

This trial is for patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS). Participants must be eligible for stem cell transplant and have adequate organ function. Specific details on inclusion and exclusion criteria are not provided.Check my eligibility

What is being tested?

The trial tests a combination of targeted radiation therapy called total marrow lymphoid irradiation, chemotherapy drugs like fludarabine, melphalan, possibly thiotepa, and Orca-T cells—a type of engineered donor T-cell graft—to treat AML, ALL or MDS.See study design

What are the potential side effects?

Potential side effects may include damage to bone marrow, increased risk of infections due to low blood cell counts, reactions from the body against the donor cells (graft-versus-host disease), nausea from chemotherapy drugs, and fatigue.

Eligibility Criteria

Inclusion Criteria

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

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My lung function tests are at least half of what is expected for someone my age and size.

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I am between 60 and 75 years old.

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I am able to care for myself but may not be able to do active work.

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My cancer diagnosis is confirmed and falls under specific blood cancer types.

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My kidney function test shows a creatinine clearance of 60 mL/min or more.

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Exclusion Criteria

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

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I have had a stem cell transplant from a donor.

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I have undergone more than 3 intensive chemotherapy treatments to try to cure my cancer.

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I do not have any uncontrolled illnesses or infections needing antibiotics.

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I am not pregnant or breastfeeding.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of therapy to relapse/progression, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of therapy to relapse/progression, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of therapy to relapse/progression, up to 2 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Acute graft versus host disease (GVHD) of grades 2-4 and 3-4

Chronic Graft versus Host Disease rate

Incidence of adverse events

+3 more

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: Treatment (TMLI, fludarabine, melphalan, Orca-T)Experimental Treatment13 Interventions

PREPARATIVE REGIMEN: Patients undergo TMLI BID on days -8 to -5, followed by fludarabine IV on days -4 to -2 and melphalan IV on day -2. Patients receiving the lowest dose of TMLI also receive thiotepa IV on days -4 and -3. HCT: Patients receive Orca-T CD34+HSPC and Treg products IV on day 0, followed by the Orca-T tcon product IV on day 2. GVHD PROPHYLAXIS: Patients undergoing haplo-HCT receive tacrolimus starting on day 14 and continuing until day 90 with a taper per treating physician's discretion. Patients also undergo ECHO or MUGA scans, DECT/MRI scans, bone marrow biopsies/aspirates, and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~1810

Bone Marrow Aspiration

2011

Completed Phase 2

~1780