Drugs / NELDALEUCEL
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06549751 | Jul 2026 → Jul 2028 expected | malignant pancreatic neoplasm, pancreatic exocrine neoplasm | Marker Therapeutics, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05798897 | Jan 2023 → Feb 2028 expected | Hodgkins lymphoma, non-Hodgkin lymphoma | Marker Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-11-03 | Marker Therapeutics, Inc. | Results Marker Therapeutics Announces Upcoming Presentations on MT-601 in Relapsed Non-Hodgkin and Hodgkin Lymphoma at the 67th ASH Annual Meeting markertherapeutics.com ↗
Among patients with Non-Hodgkin lymphoma (NHL), including those who relapsed after anti-CD19 directed CAR-T cell therapy, the objective response rate (ORR) was 66% (8 out of 12) with 50% achieving a complete response (CR). |
| 2025-08-26 | Marker Therapeutics, Inc. | Results Marker Therapeutics Provides Update on Phase 1 APOLLO Study Highlighting Encouraging Overall Response Rates in Relapsed Lymphoma markertherapeutics.com ↗
Ongoing Phase 1 APOLLO study investigating MT-601 in patients with relapsed B cell lymphoma showed 66% of Non-Hodgkin Lymphoma (NHL) patients achieving objective response rates, with 50% demonstrating complete response (CR) |
| 2025-05-20 | Marker Therapeutics, Inc. | Results Marker Therapeutics Reports that Lymphodepletion Improves the Expansion and Persistence of Multi-Antigen Recognizing T Cells in Patients with Lymphoma markertherapeutics.com ↗ |
| 2024-12-19 | Marker Therapeutics, Inc. | Results Marker Therapeutics Provides a Clinical Update on MT-601 in Patients with Lymphoma markertherapeutics.com ↗
Study participants showed early objective responses with and without lymphodepletion. |
| 2024-04-08 | Marker Therapeutics, Inc. | Results Principal Investigator from City of Hope National Medical Center Invited to Present Clinical Data from Marker Therapeutics APOLLO Study at 11th Global Summit on Hematologic Malignancies markertherapeutics.com ↗
Study participants tolerated initial dose level well and demonstrated durable objective responses after MT-601 treatment |
| 2024-01-22 | Marker Therapeutics, Inc. | Regulatory Marker Therapeutics Receives Approval from United States Adopted Name (USAN) Council and International Nonproprietary Names (INN) Expert Committee for “Neldaleucel” as Nonproprietary Name for MT-601 markertherapeutics.com ↗
The adoption of the name neldaleucel is a step forward for continued advancements of multiTAA therapies Marker is developing. |
| 2023-12-11 | Marker Therapeutics, Inc. | Results Marker Therapeutics Announces Sustained Complete Response in First Lymphoma Patient Treated with MT-601 following CAR T Relapse markertherapeutics.com ↗
Marker reports today that six months following the initial treatment with MT-601 the study participant has maintained complete response to treatment. |
| 2023-09-11 | Marker Therapeutics, Inc. | Results Marker Therapeutics Announces Complete Response in First Lymphoma Patient Treated with MT-601 after CAR T Relapse markertherapeutics.com ↗ |
| 2023-05-31 | Marker Therapeutics, Inc. | Results Marker Therapeutics Reports Pre-Clinical Data of its MT-601 MultiTAA-Specific T Cell Product Candidate in Lymphoma Cells markertherapeutics.com ↗
Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced pre-clinical data from the Company’s multiple tumor-associated antigens (multiTAA)-specific T cell product candidate MT-601 in lymphoma cells, including CD19 CAR T refractory cells. |
| 2022-11-22 | Marker Therapeutics, Inc. | Regulatory Marker Therapeutics Announces FDA Clearance of IND for MT-601, its Six-Antigen T Cell Therapy for the Treatment of Pancreatic Cancer markertherapeutics.com ↗
the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for MT-601 |
| 2022-08-04 | Marker Therapeutics, Inc. | Regulatory Marker Therapeutics Announces FDA Clearance of IND for MT-601, the six-antigen targeted T Cell Therapy for the treatment of relapsed/refractory Non-Hodgkin Lymphoma markertherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for MT-601 |
| 2022-01-19 | Marker Therapeutics, Inc. | Regulatory Marker Therapeutics Receives FDA Orphan Drug Designation for its Multi-Antigen Targeted T Cell Therapy for Pancreatic Cancer markertherapeutics.com ↗
the United States Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug designation to MT-601, a multi-tumor-associated antigen (MultiTAA)-specific T cell product optimized for the treatment of patients with pancreatic cancer. |
All press releases naming this drug 16 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NELDALEUCEL | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068456 ↗ |
| Known as | MT-601 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06549751 ↗ |
| Modality | Cell therapy | “Patient-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-601)” NCT06549751 ↗ |
| Route | Intravenous | “MT-601 will be administered intravenously over no less than 5 minutes” NCT06549751 ↗ |