FDA Events for CytoMed Therapeutics (GDTC)
This section highlights FDA-related milestones and regulatory updates for drugs developed by CytoMed Therapeutics (GDTC).
Over the past two years, CytoMed Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ANGELICA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ANGELICA - FDA Regulatory Timeline and Events
ANGELICA is a drug developed by CytoMed Therapeutics for the following indication: allogeneic chimeric antigen receptor T cell (CAR-T cell) against blood and solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ANGELICA
- Announced Date:
- November 20, 2024
- Indication:
- allogeneic chimeric antigen receptor T cell (CAR-T cell) against blood and solid tumors
Announcement
CytoMed Therapeutics Limited is pleased to announce that the first patient has been dosed in its first-in-human Phase I dose-escalation clinical trial (NCT05302037) ("ANGELICA Trial").
AI Summary
CytoMed Therapeutics Limited, a Singapore-based biopharma company, has marked an important milestone by dosing the first patient in its first-in-human Phase I dose-escalation clinical trial (NCT05302037), also called the ANGELICA Trial. This study evaluates a new allogeneic therapy that uses donor-derived gamma delta T cells, modified with a chimeric antigen receptor, to target advanced solid tumors and blood cancers. Unlike traditional CAR-T treatments that rely on a patient’s own cells, this innovative approach uses cells from eligible donors, which could lead to higher quality cells, lower production costs, and improved patient access. The ANGELICA Trial is now running under clinical trial authorization from Singapore’s Health Sciences Authority, marking a significant step forward in exploring novel immunotherapies to treat various challenging cancer types.
Read Announcement- Drug:
- ANGELICA
- Announced Date:
- October 7, 2024
- Indication:
- allogeneic chimeric antigen receptor T cell (CAR-T cell) against blood and solid tumors
Announcement
CytoMed Therapeutics Limited a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the treatment of various cancers including blood and solid cancers has obtained full approval for its first-in-human Phase I clinical trial ("ANGELICA Trial") using its patented allogeneic chimeric antigen receptor T cell ("CAR-T cell") against several blood and solid tumors in collaboration with the National University Hospital ("NUH") of Singapore.
AI Summary
CytoMed Therapeutics Limited, a Singapore-based biopharmaceutical company, has received full approval to start its first-in-human Phase I clinical trial, called the ANGELICA Trial. The trial will test their patented allogeneic chimeric antigen receptor T cell (CAR-T cell) therapy. Unlike traditional CAR-T therapies that use a patient’s own cells, CytoMed’s approach uses cells taken from healthy donors, which may improve the quality of the treatment and lower production costs. This novel treatment targets both blood and solid tumors and is conducted in collaboration with the National University Hospital of Singapore. The ANGELICA Trial represents an important step in developing off-the-shelf cell therapies that do not require patient-specific matching, potentially increasing timely access to cancer treatment. The trial has received support from Singapore’s Ministry of Health through the NMRC Clinical Trial Grant scheme.
Read Announcement
CytoMed Therapeutics FDA Events - Frequently Asked Questions
As of now, CytoMed Therapeutics (GDTC) has not received any FDA approvals for its therapy in the last two years.
In the past two years, CytoMed Therapeutics (GDTC) has reported FDA regulatory activity for ANGELICA.
The most recent FDA-related event for CytoMed Therapeutics occurred on November 20, 2024, involving ANGELICA. The update was categorized as "Dose Update," with the company reporting: "CytoMed Therapeutics Limited is pleased to announce that the first patient has been dosed in its first-in-human Phase I dose-escalation clinical trial (NCT05302037) ("ANGELICA Trial")."
Currently, CytoMed Therapeutics has one therapy (ANGELICA) targeting the following condition: allogeneic chimeric antigen receptor T cell (CAR-T cell) against blood and solid tumors.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:GDTC) was last updated on 7/13/2025 by MarketBeat.com Staff
