FDA OKs Trial of Novel CAR T-Cell Therapy in T-ALL/LBL
The “off-the-shelf” CAR T-cell therapy CTD402 will be evaluated in a phase 1b/2 trial for patients with T-cell acute lymphoblastic leukemia and lymphoma.
US FDA
- The FDA has cleared an investigational new drug (IND) application for CTD402, a CD7-targeted universal chimeric antigen receptor (CAR) T-cell therapy.
- This approval is intended for the treatment of pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL).
- With this, a phase 1b/2 trial with a simplified dose-finding design will evaluate the agent in this patient population.
The FDA has approved the IND application of CTD402 for the treatment of pediatric and adult patients with relapsed/refractory T-ALL/LBL, allowing for the start of a single-arm, open-label phase 1b/2 trial.1
The study will utilize a dose-finding design and aims to optimize dosing of CTD402 and accelerate clinical development.
"We are delighted that CTD402 has received IND clearance from the US FDA for a phase 1b/2 trial with a simplified dose-finding design, accelerating our clinical development timeline in the United States," stated Jiangtao Ren, PhD, president and chief scientific officer of Bioheng, in a press release. "[Investigator-initiated trials] study results showed an impressive [overall response rate], alongside a favorable safety profile. These results validate our ANSWER platform's ability to deliver both rapid therapeutic impact and reduced patient risk, positioning CTD402 as a potential best-in-class therapy for T-cell malignancies."
Microscopic examination revealing red blood cells, white blood cells, neutrophils, eosinophils: ©AkuAku - stock.adobe.com
CTD402 is a universal CAR T-cell therapy that works by targeting CD7 that comes from healthy donors. The agent is currently undergoing evaluation for the treatment of adult and pediatric patients with T-ALL/LBL.
The product is genetically modified to avoid fratricide, graft-vs-host disease, and host-vs-graft rejection.1 At the same time, CTD402 may enhance antitumor activity.
Further, CTD402 can be considered “off-the-shelf” as it can be prepared in a single batch for multiple patients in need of CAR T-cell therapy.
In addition to CTD402, Bioheng Therapeutics is currently developing CTA311 for B-cell ALL and non-Hodgkin lymphoma, CTF50X for acute myeloid leukemia, CTB001 for gastric and pancreatic cancer, CTE001 for breast and ovarian cancer, and TAA for solid tumors.2
REFERENCES:
Bioheng Therapeutics announces FDA clearance of IND application for CD7 UCAR T cell therapy in T-ALL/LBL. News release. Bioheng Therapeutics US LLC. March 5, 2025. Accessed March 5, 2025. https://tinyurl.com/2dkpcsj5
Science & products. Bioheng Therapeutics. Accessed March 5, 2025. https://www.bioheng.com/Science_Products.html
