NCT02203903: RESOLVE

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

Recruiting now Phase 1 Last updated 31 May 2025

What this trial tests

Phase 1 trial testing Tumor associated antigen lymphocytes (TAA-T) in Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS in 50 participants. Currently enrolling.

Timeline

1 January 2015

Primary endpoint
30 November 2026

28 June 2027

Quick facts

Lead sponsor	Catherine Bollard
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 January 2015
Primary completion	30 November 2026
Estimated completion	28 June 2027
Sites	2 locations across United States

Drugs / interventions tested

• Tumor associated antigen lymphocytes (TAA-T) — full drug profile →

Conditions studied

• Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS — all drugs for Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS →

Sponsor

Catherine Bollard — full company profile →

Who can join

Adults 6 Months to 80, any sex, with Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Assessing the Future of Solid Tumor Immunotherapy.
   Guha P, Heatherton KR, O'Connell KP, Alexander IS, et al · · 2022 · cited 85× · PMID 35327456 · DOI 10.3390/biomedicines10030655
2. Cancer Testis Antigens and Immunotherapy: Where Do We Stand in the Targeting of PRAME?
   Al-Khadairi G, Decock J. · · 2019 · cited 85× · PMID 31311081 · DOI 10.3390/cancers11070984
3. Immuno-transcriptomic profiling of extracranial pediatric solid malignancies.
   Brohl AS, Sindiri S, Wei JS, Milewski D, et al · · 2021 · cited 60× · PMID 34818552 · DOI 10.1016/j.celrep.2021.110047
4. The twisted survivin connection to angiogenesis.
   Sanhueza C, Wehinger S, Castillo Bennett J, Valenzuela M, et al · · 2015 · cited 56× · PMID 26584646 · DOI 10.1186/s12943-015-0467-1
5. T-Cell Immunotherapies Targeting Histocompatibility and Tumor Antigens in Hematological Malignancies.
   Janelle V, Rulleau C, Del Testa S, Carli C, et al · · 2020 · cited 36× · PMID 32153583 · DOI 10.3389/fimmu.2020.00276
6. T cell optimization for graft-versus-leukemia responses.
   Biernacki MA, Sheth VS, Bleakley M. · · 2020 · cited 31× · PMID 32376800 · DOI 10.1172/jci.insight.134939
7. Outcome of donor-derived TAA-T cell therapy in patients with high-risk or relapsed acute leukemia post allogeneic BMT.
   Kinoshita H, Cooke KR, Grant M, Stanojevic M, et al · · 2022 · cited 28× · PMID 35244681 · DOI 10.1182/bloodadvances.2021006831
8. Trial Watch: Adoptive cell transfer for oncological indications.
   Aranda F, Buqué A, Bloy N, Castoldi F, et al · · 2015 · cited 28× · PMID 26451319 · DOI 10.1080/2162402x.2015.1046673