A Study of CTD402 in T-ALL/LBL Patients

Conditions

• Acute Lymphocytic Leukemia Refractory
• Lymphoma, Lymphoblastic

Eligibility Criteria

Sex

ALL

Age

1 Year - N/A

Healthy Volunteers

Not accepted

Interventions

• CTD402 CAR T Cell Injection — DRUG
  CAR T cells

Study Details

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 1 year 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.

Key Dates

First listed

Jul 17, 2025

Start date

Oct 7, 2025

Status verified

Aug 2026

Primary completion

Sep 30, 2028

Completion

Dec 30, 2028

Study Design

Enrollment

118 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: R/R T-ALL/LBL
• Experimental: T-ALL/LBL in remission but with minimal residual disease

Primary Outcome Measure

Safety Profile [ Time Frame: 24 months ]

Central Contacts

• Jan Davidson-Moncada, MD, PhD
  917-573-8538
  [email protected]

Locations (8)

Find similar trials in Palo Alto, CA