Multi-institutional Prospective Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of VEry High Risk Hematopoietic Malignancies

Conditions

• Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS

Eligibility Criteria

Sex

ALL

Age

6 Months - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Tumor associated antigen lymphocytes (TAA-T) — BIOLOGICAL
  TAA-T may be generated from donors or recipients and will be tested for specificity to 3 tumor antigens commonly found in hematological malignancies (WT1, PRAME, and SURVIVIN,). The goal of this cell infusion will be to initiate an immune response to residual leukemia or lymphoma that includes multiple antigens and may prevent tumor evasion (through decreased expression of a single antigen).

Study Details

This Phase I dose-escalation trial is designed to evaluate the safety of administering rapidly -generated tumor multi-antigen associated -specific cytotoxic T lymphocytes, to HSCT recipients with high risk AML and MDS.

Key Dates

Start date

Jan 1, 2015

Status verified

May 2025

Primary completion

Nov 30, 2026

Completion

Jun 28, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tumor associated antigen lymphocytes (TAA-T)
  TAA-T will be infused any time after neutrophil engraftment post-HSCT or day 30, whichever comes first. All infusions will be within 5 months post-HSCT. Patients will receive a TAA-T cell dose of 4 x 107 cells/m2.

Primary Outcome Measure

Safety of investigational product (TAA-T) [ Time Frame: 45 days ]

Central Contacts

• Fahmida Hoq, MBBS, MS
  202-476-3634
  [email protected]

Locations (2)

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