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A Study of CTD402 in T-ALL/LBL Patients

NCT07070219 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-02-05

No results posted yet for this study

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.

Conditions

  • Acute Lymphocytic Leukemia Refractory
  • Lymphoma, Lymphoblastic

Interventions

DRUG

CTD402 CAR T Cell Injection

CAR T cells

Sponsors & Collaborators

  • BIOHENG THERAPEUTICS US LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-07
Primary Completion
2028-09-30
Completion
2028-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070219 on ClinicalTrials.gov