NCT05445765

Anti-CD33 CAR-T Cells for the Treatment of Relapsed/Refractory CD33+ Acute Myeloid Leukemia

Status unknown Phase 1 Last updated 6 July 2022

What this trial tests

Phase 1 trial testing anti-CD33 CAR T cells in Relapsed and/or Refractory Acute Myeloid Leukemia in 10 participants. Status unknown.

Timeline

1 July 2022

Primary endpoint
30 June 2024

30 June 2024

Quick facts

Lead sponsor	iCell Gene Therapeutics
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 July 2022
Primary completion	30 June 2024
Estimated completion	30 June 2024
Sites	1 location across China

Drugs / interventions tested

• anti-CD33 CAR T cells

Conditions studied

• Relapsed and/or Refractory Acute Myeloid Leukemia — all drugs for Relapsed and/or Refractory Acute Myeloid Leukemia →
• High Risk Hematologic Malignancies — all drugs for High Risk Hematologic Malignancies →

Sponsor

iCell Gene Therapeutics — full company profile →

Who can join

Adults 2 to 60, any sex, with Relapsed and/or Refractory Acute Myeloid Leukemia or High Risk Hematologic Malignancies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD33 CAR-T cells in patients with relapsed and/or refractory, high risk hematologic malignancies.

Publications & conference data

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

1. CAR-T cell therapy for cancer: current challenges and future directions.
   Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, et al · · 2025 · cited 81× · PMID 40610404 · DOI 10.1038/s41392-025-02269-w
2. Recent Advances in Immune-Based Therapies for Acute Myeloid Leukemia.
   Restelli C, Ruella M, Paruzzo L, Tarella C, et al · · 2024 · cited 36× · PMID 38904305 · DOI 10.1158/2643-3230.bcd-23-0202
3. Targets for chimeric antigen receptor T-cell therapy of acute myeloid leukemia.
   Schorr C, Perna F. · · 2022 · cited 21× · PMID 36605213 · DOI 10.3389/fimmu.2022.1085978
4. Proteomic Characterization of Acute Myeloid Leukemia for Precision Medicine.
   Casado P, Cutillas PR. · · 2023 · cited 15× · PMID 36805445 · DOI 10.1016/j.mcpro.2023.100517
5. A perspective of immunotherapy for acute myeloid leukemia: Current advances and challenges.
   Chen Y, Wang J, Zhang F, Liu P. · · 2023 · cited 13× · PMID 37153761 · DOI 10.3389/fphar.2023.1151032
6. A structural, genetic and clinical comparison of CAR-T cells and CAR-NK cells: companions or competitors?
   Andrea AE, Chiron A, Sarrabayrouse G, Bessoles S, et al · · 2024 · cited 8× · PMID 39430751 · DOI 10.3389/fimmu.2024.1459818
7. Recent advances in CAR-T cell therapy for acute myeloid leukaemia.
   Gao C, Li X, Xu Y, Zhang T, et al · · 2024 · cited 8× · PMID 38712978 · DOI 10.1111/jcmm.18369
8. Recent advances of CAR-T cells in acute myeloid leukemia.
   Deng H, Wang Q, Tong X, Cui Z, et al · · 2025 · cited 5× · PMID 40144774 · DOI 10.1177/20406207251326802