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Virus Therapy

Genetically Modified T-cells for Infections in Cancer Patients

Phase 1

Recruiting

Led By May Daher, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

For BKV infection, patients need to have polymerase chain reaction (PCR) positive for BKV (in peripheral blood or urine) with consistent clinical symptoms

For COVID-19 infection, patients need to have COVID-19 related pneumonia/acute respiratory distress syndrome (ARDS) to be enrolled, defined as patients with a positive COVID-19 test (bronchoalveolar lavage [BAL], nasal or pharyngeal) and radiological and clinical signs of pneumonia or ARDS

Must not have

Patients with active steroid refractory graft versus host disease (GVHD)

Patients on immunosuppressive therapy other than tacrolimus, sirolimus, or steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the feasibility and safety of genetically modified T-cells to control viral infections in immunocompromised cancer patients. If successful, this could provide a new, less toxic option for treating these life-threatening infections.

Who is the study for?

This trial is for adults with blood cancers and certain viral infections (ADV, BKV, CMV, JCV, COVID-19) after stem cell transplant or with pneumonia from COVID-19. They must be able to consent and agree to long-term follow-up. Women who can have children should use two birth control methods during the study.

What is being tested?

The trial tests genetically engineered virus-specific T-cells designed to fight specific viruses causing infections in cancer patients with weakened immune systems. It aims to see if these modified cells are safe and effective at controlling the infection.

What are the potential side effects?

Potential side effects may include immune reactions as the body adjusts to the new T-cells, symptoms related to inflammation or damage of infected tissues as viruses are targeted, and typical risks associated with cellular therapies.

Eligibility Criteria

Inclusion Criteria

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

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I have symptoms and tested positive for BKV in my blood or urine.

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I have COVID-19 and am suffering from pneumonia or ARDS.

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I have been diagnosed with JC virus infection affecting my brain or other organs.

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I am 18 years old or older.

Exclusion Criteria

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

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I have GVHD that hasn't responded to steroid treatment.

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I am on immunosuppressive drugs, but not tacrolimus, sirolimus, or steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 for viral infections (virus-specific CTLs)Experimental Treatment1 Intervention

Patients receive virus-specific CTLs intravenously (IV) over 30 minutes. Patients with partial response, stable disease, or progressive disease may receive up to 8 additional infusions of virus-specific CTL at least 2 weeks between each infusion.

0 / 6Eligibility criteria met