NCT07070219

A Study of CTD402 in T-ALL/LBL Patients

A Single-Arm, Open-Label, Multi-Center, Phase 1b/ 2 Study to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTD402 in Participants With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and Lymphoblastic Lymphoma (T-LBL) (TENACITY-01)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: BIOHENG THERAPEUTICS US LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The goal of the TENACITY-01 clinical trial is to learn if CTD402 UCART is safe and effective for relapsed/refractory T-ALL/LBL patients. Participants with relapsed/refractory T-ALL/LBL over the age of 12 will be eligible to participate. Participants will receive one infusion of CTD402 on Day 0 and will be evaluated for anti-tumor activity by an independent review committee based on the NCCN criteria for T-ALL and the Lugano 2014 criteria for T-LBL. Patients will be followed for up to 24 months in this study and will be required to enroll under a separate long term follow up protocol to be followed for up to 15 years.

Detailed description

TENACITY-01 is a single-arm, open-label, multi-center, Phase 1b/2 study to assess the safety and efficacy of CTD402 in adolescent (≥ 12 to 17 years) and adult participants with relapsed/refractory (r/r) T-ALL/LBL. Approximately 18 participants will be enrolled in the Phase 1b portion of the study to evaluate the safety and establish the RP2D of CTD402, with approximately 18 participants receiving CTD402 at RP2D. Approximately 36 participants will be enrolled in the Phase 2 portion of the study to further confirm the efficacy and safety of CTD402. Both the phase 1b and phase 2 portions will consist of the following sequential phases: screening (up to 2 weeks), lymphodepletion period (within 7 days prior to treatment), CTD402 treatment (a single dose), primary follow-up period (up to 2 years). Once a participant receives the first dose of lymphodepleting chemotherapy regimen, the participant will be considered enrolled into the study. Long term follow-up will be conducted under a separate protocol until 15 years following CTD402 infusion for survival, toxicity, RCR monitoring, and secondary malignancy.

Conditions

• Acute Lymphocytic Leukemia Refractory
• Lymphoma, Lymphoblastic

Interventions

Type	Name	Description
DRUG	CTD402 CAR T Cell Injection	CAR T cells

Timeline

• Start date: 2025-10-07
• Primary completion: 2028-09-30
• Completion: 2028-12-30
• First posted: 2025-07-17
• Last updated: 2026-02-05

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study