Multi Tumor-Associated Antigen-Specific T Lymphocytes to Treat Patients With High Risk Solid Tumors

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT05238792
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
1 Year - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tumor-associated antigen-specific T cell (TAA-T) — BIOLOGICAL
    Patients will receive cells due to the presence of refractory disease, or high risk for disease relapse and/or minimal residual detectable disease following conventional therapy. The treatment schedule is as follows: Patients will receive an infusion of partially HLA-matched TAA-T any time \>1 week after completing most recent course of conventional (noninvestigational) therapy for their disease. For patients enrolled to DL2 or DL3, they will receive protocol-described lymphodepletion (LD) chemotherapy (fludarabine and cyclophosphamide) \>2 weeks from most recent course of conventional therapy and post nadir and recovery from the prior therapy. Patients will be enrolled to one of the following TAA-T dose levels: BSA \<1.20 Dose Level 2 (+/- ablation + low dose TAA-T cells) 2x10\^7 Dose Level 3 (+/- ablation + high dose TAA-T cells) 4x10\^7 BSA\>=1.20 Dose Level 2 (+/- ablation + low dose TAA-T cells) 4x10\^7 Dose Level 3 (+/- ablation + high dose TAA-T cells) 8x10\^7

Study Details

This is an open-label phase I dose-escalation study to evaluate the safety of partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation for pediatric and adult patients with high-risk solid tumors due to the presence of refractory, relapsed and/or minimal residual detectable disease following conventional therapy (e.g., chemotherapy, surgery, radiation, autologous stem cell transplant, or targeted therapy).

Key Dates

First listed
Feb 14, 2022
Start date
Nov 17, 2021
Status verified
Jul 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: TAA-T Infusion
    Treatment with partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen-specific T cell (TAA-T) therapy following lymphodepleting conditioning with or without local tumor ablation.

Primary Outcome Measure

To determine the safety of administering partially HLA-matched TAA-T cells [ Time Frame: 45 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Amy Hont, MBBS, MS
[email protected]
202-476-3887
Amy Hont, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Children's National Hospital· Washington D.C., DC

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