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Virus Therapy

CTL Therapy for Multivirus Infections

Phase 1

Waitlist Available

Led By Catherine Bollard, MD

Research Sponsored by Catherine Bollard

Eligibility Criteria Checklist

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

Must have

Received prior myeoloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or PBSC within 12 months

Patient or parent/guardian capable of providing informed consent

Must not have

Unable to wean steroids to ≤0.5 mg/kg/day prednisone

Received donor lymphocyte infusion in last 28 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether or not these CTLs can prevent or treat CMV, EBV and adenovirus infections after transplant.

Who is the study for?

This trial is for patients with blood cancers or genetic diseases who've had a stem cell transplant within the last year. They should be at risk of, or currently fighting, CMV, EBV, or Adenovirus infections. Participants need to have stable vital signs and organ function and not be on high doses of steroids. Pregnant women and those with uncontrolled cancer relapse or other severe infections cannot join.

What is being tested?

The study tests whether T cells (CTLs) grown from donors can prevent or treat viral infections like CMV, EBV, and Adenovirus in patients post-transplant. CTLs are trained in the lab to fight these viruses and then infused into patients to boost their immune response against potential life-threatening infections.

What are the potential side effects?

While specific side effects aren't listed here, similar treatments often involve risks such as infusion reactions (like fever or chills), increased vulnerability to other infections due to immune system modification, allergic responses, and potential GVHD (graft-versus-host disease).

Eligibility Criteria

Inclusion Criteria

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

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I had a stem cell transplant from a donor within the last year.

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I (or my guardian) can understand and agree to the study's terms.

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I can do most activities but may need help.

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I am taking less than 0.5 mg/kg/day of prednisone.

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I am receiving cell therapy for EBV, CMV, or Adenovirus infections.

Exclusion Criteria

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

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I cannot reduce my steroid dose to less than or equal to 0.5 mg/kg/day.

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I received a donor lymphocyte infusion in the last 28 days.

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My cancer is currently growing or spreading.

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My bilirubin levels are very high.

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My graft-versus-host disease is more severe than grade 2.

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I do not have any uncontrolled infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Assessments of patients with adverse events after mukti-virus specific CTL infusion.

Secondary study objectives

Assessments of viral load response to the CTL infusion

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: CTL for CMV seropositive donorsExperimental Treatment1 Intervention

CTL for CMV seropositive donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV seropositive donors- three different dose levels are selected, starting with 5 x 106 (a T cell number more than an order of magnitude lower than that administered at the time of an unmanipulated marrow infusion), followed by 1 x 107 and a final dose 2 x 107 mCTLs/m2. Two additional doses (at the same level)will be administered 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL.

Group II: CTL for CMV naïve donorsExperimental Treatment1 Intervention

CTL for CMV naïve donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton)for CMV naïve donors-each group will undergo an identical dose escalation. Three different dose levels are selected, starting with 5 x 106 (a T cell number more than an order of magnitude lower than that administered at the time of an unmanipulated marrow infusion), followed by 1 x 107 and a final dose 2 x 107 mCTLs/m2. Two additional doses (at the same level)will be administered 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL.

0 / 11Eligibility criteria met