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A Study of CTD402 in T-ALL/LBL Patients

ConditionsAcute Lymphocytic Leukemia RefractoryLymphoma, Lymphoblastic
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorImviva Bio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, ≥ 1 year of age.

Participants with body weight ≥ 40 kilogram.

Relapsed or refractory disease after two or more lines of systemic therapy;

The first relapse occurs within 12 months after first remission;

Disqualifiers

Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.

Active central nervous system (CNS) involvement

History of heart failure New York Heart Association (NYHA) class III or IV;

History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.

Trial design

Design model

Single group

Treatments tested in this trial

  • CTD402 CAR T Cell Injection

    Drug

    CAR T cells

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: R/R T-ALL/LBLExperimental treatment 1 intervention
Group B: T-ALL/LBL in remission but with minimal residual diseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety Profile

Incidence of dose limiting toxicities including incidence of adverse events and graft vs host disease

Time frame
24 months
2

Response Evaluation

Percentage of participants who achieve overall complete remission (OCR) assess by an independent review committee

Time frame
24 months

Secondary outcomes

1

Characterize the cPK profile of CTD402

CTD402 cellular pharmacokinetic (PK)

Time frame
24 months

Other outcomes

Sponsors and contacts

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Imviva Bio

Lead sponsor

Source ClinicalTrials.gov
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