Who is sponsoring NCT03126864?

NCT03126864 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT03126864?

Interventions in NCT03126864: Leukapheresis, Fludarabine, Cyclophosphamide, CD33-CAR-T Cell Infusion.

What condition does NCT03126864 study?

NCT03126864 studies Hematopoietic/Lymphoid Cancer, Acute Myeloid Leukemia.

Is NCT03126864 still recruiting?

NCT03126864 is currently terminated. Last updated 4 November 2019.

Last reviewed 2019-11-04 · How we verify

NCT03126864

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Adoptive Cellular Therapy Using Autologous T Cells Transduced With Lentivirus to Express a CD33 Specific Chimeric Antigen Receptor in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia

Terminated Phase 1 Last updated 4 November 2019

What this trial tests

Phase 1 trial testing Leukapheresis in Hematopoietic/Lymphoid Cancer in 11 participants. Terminated before completion.

Timeline

4 August 2017

Primary endpoint
10 October 2019

10 October 2019

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	4 August 2017
Primary completion	10 October 2019
Estimated completion	10 October 2019
Sites	1 location across United States

Drugs / interventions tested

Leukapheresis — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →
Cyclophosphamide (cyclophosphamide) — full drug profile →
CD33-CAR-T Cell Infusion — full drug profile →

Conditions studied

Hematopoietic/Lymphoid Cancer — all drugs for Hematopoietic/Lymphoid Cancer →
Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 1 to 80, any sex, with Hematopoietic/Lymphoid Cancer or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn about the safety and tolerability of 3 different doses of CD33-CAR-T cells (referred to throughout the consent as "T-cells") in patients who have CD33-positive acute myeloid leukemia (AML) that is relapsed (has come back) or refractory (has not responded to treatment). CD33-CAR-T is made by genetically modifying (changing) your T-cells (a type of white blood cell). T-cells are genetically changed to help target leukemia cells. This is an investigational study. CD33-CAR-T is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work. Up to 39 participants will be enrolled in this study. All will take part at MD Anderson.

Publications & conference data

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

Targeting cancer stem cell pathways for cancer therapy.
Yang L, Shi P, Zhao G, Xu J, et al · · 2020 · cited 1354× · PMID 32296030 · DOI 10.1038/s41392-020-0110-5
Cancer Stem Cells-Origins and Biomarkers: Perspectives for Targeted Personalized Therapies.
Walcher L, Kistenmacher AK, Suo H, Kitte R, et al · · 2020 · cited 688× · PMID 32849491 · DOI 10.3389/fimmu.2020.01280
Genetic Inactivation of CD33 in Hematopoietic Stem Cells to Enable CAR T Cell Immunotherapy for Acute Myeloid Leukemia.
Kim MY, Yu KR, Kenderian SS, Ruella M, et al · · 2018 · cited 388× · PMID 29856956 · DOI 10.1016/j.cell.2018.05.013
Immune escape and immunotherapy of acute myeloid leukemia.
Vago L, Gojo I. · · 2020 · cited 242× · PMID 32235097 · DOI 10.1172/jci129204
Management guidelines for paediatric patients receiving chimeric antigen receptor T cell therapy.
Mahadeo KM, Khazal SJ, Abdel-Azim H, Fitzgerald JC, et al · · 2019 · cited 165× · PMID 30082906 · DOI 10.1038/s41571-018-0075-2
Autologous CD33-CAR-T cells for treatment of relapsed/refractory acute myelogenous leukemia.
Tambaro FP, Singh H, Jones E, Rytting M, et al · · 2021 · cited 159× · PMID 33833386 · DOI 10.1038/s41375-021-01232-2
Immune checkpoint blockade and CAR-T cell therapy in hematologic malignancies.
Wang H, Kaur G, Sankin AI, Chen F, et al · · 2019 · cited 138× · PMID 31186046 · DOI 10.1186/s13045-019-0746-1
CAR-T cell combination therapy: the next revolution in cancer treatment.
Al-Haideri M, Tondok SB, Safa SH, Maleki AH, et al · · 2022 · cited 106× · PMID 36419058 · DOI 10.1186/s12935-022-02778-6

Verify or expand the search:

Other trials of Leukapheresis

Trials testing the same drug.

NCT07261657 — N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive C · EARLY_PHASE1 · not yet recruiting
NCT07316010 — Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma · Phase 2 · not yet recruiting
NCT06968195 — Autologous CAR T Cells Targeting GPC3 (RPCAR01) for the Treatment of Advanced or Metastatic GPC3 Expressing Hepatocellul · Phase 1 · suspended
NCT06930352 — Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for S · Phase 2 · not yet recruiting
NCT07219147 — 177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer · Phase 1 · recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03126864 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 4 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03126864.

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