VST Therapy for Post-Transplant Viral Infections
(NATS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMichael D Keller, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Children's National Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

This Phase I dose-escalation trial is designed to evaluate the safety of rapidly generated multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus, HHV6, BK virus, JC virus, and human parainfluenza-3 (HPIV3), derived from eligible HSCT donors. In this trial, we will utilize a rapid generation protocol for broad spectrum multivirus-specific T cells for infusion to recipients of allogeneic hematopoietic stem cell transplant (HSCT), who are at risk of developing EBV, CMV, adenovirus, HHV6, BKV, JCV and/or HPIV3, or with PCR/culture confirmed active infection(s) of EBV, CMV, adenovirus, HHV6, BKV, JCV, and/or HPIV3 that has failed to resolve with at least 14 days of standard antiviral therapy (if available and tolerated). These cells will be derived from HSCT donors, and the study agent will be assessed at each dose for evidence of dose-limiting toxicities (DLT). This study will have two arms: Arm A will include patients who receive prophylactic treatment, and Arm B will include patients who receive VSTs for one or more active infections with targeted viruses. Determination of the study arm will be determined by the patient's clinical status. Study arms will each be analyzed for safety endpoints and secondary endpoints.

Research Team

Michael D Keller, MD

Principal Investigator

Children's National Research Institute

Eligibility Criteria

This trial is for patients who've had a bone marrow or stem cell transplant and are at risk of, or currently have, certain viral infections (like EBV, CMV) that haven't improved after standard treatment. They should be relatively stable with no severe GVHD, uncontrolled cancer relapse, or recent use of other investigational drugs.

Inclusion Criteria

I am able to reduce my steroid use to less than 0.5 mg/kg/day.

I am able to perform most of my daily activities.

Pulse oximetry of > 90% on room air

See 7 more

Exclusion Criteria

I have moderate to severe graft-versus-host disease.

I haven't had cell therapy, except for transplant-related ones, in the last 28 days.

I haven't received specific immune-suppressing drugs in the last 28 days.

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Treatment Details

Interventions

Virus Specific T cells (VSTs) (CAR T-cell Therapy)

Trial OverviewThe trial tests Virus Specific T cells (VSTs) from donors to see if they're safe and can prevent or treat viral infections in people who received allogeneic hematopoietic stem cell transplants. It has two parts: one for prevention and another for active infection treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Prophylactic and treatmentExperimental Treatment1 Intervention

Virus Specific T cells (VSTs) for prophylactic and treatment of active viral infection(s) after HSCT. 3 different dose levels starting with 1 x 10E7 /m2 (a T cell number more than an order of magnitude lower than that administered at the time of an unmanipulated marrow infusion), followed by 2 x 10E7/m2 and a final dose 5 x 10E7 VSTs/m2