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RecruitingPhase 1 / Phase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Year and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 months, 15 years
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether CTD402 UCART is safe and works against T-ALL/LBL, cancers of blood-forming cells or the lymph system. It is for people age 1 or older whose cancer has come back, has not responded to treatment, or remains at very low levels. Participants receive one infusion and have follow-up for up to 24 months, plus a separate required follow-up study lasting up to 15 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 1 or older and weigh at least 40 kilograms (about 88 pounds).
  • Have T-ALL/LBL that came back or did not respond after at least two courses of treatment, first came back within 12 months of the cancer clearing, or came back after a donor stem cell transplant. For a transplant, at least 100 days must have passed before screening.
  • The criteria also include cancer remaining at very low levels: fewer than 5% immature cancer cells in the bone marrow, but at least 1 cancer cell in every 1,000 cells on an accepted test.
  • The listing also requires at least 5% immature cancer cells in the bone marrow, or cancer outside the bone marrow, at screening.
  • Have organs that work well enough.
  • Meet the study's limits for daily activity scores: ECOG 2 or less, Karnofsky 60 or higher for ages 16 and older, or Lansky 60 or higher for children under 16.

Who can't join

  • Have a genetic condition or another known condition that causes the bone marrow to fail to make enough blood cells.
  • Have active cancer in the brain or spinal cord.
  • Have a history of severe heart failure, or have had a heart attack, a procedure to open heart arteries, unstable chest pain, or another serious heart problem within the past 12 months.
  • Have a condition you were born with that weakens the immune system.
  • Have an infection that is not controlled.
  • Have a known history of HIV, hepatitis C, or syphilis infection.
  • Have active or inactive hepatitis B infection.
  • Test positive at screening for Epstein-Barr virus (EBV) or cytomegalovirus (CMV) on a DNA or IgM antibody test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: 1. Male or female, ≥ 1 year of age. 2. Participants with body weight ≥ 40 kilogram. 3. A) Relapsed or refractory T-ALL/LBL or MRD positive defined as one of the following: * Relapsed or refractory disease after two or more lines of systemic therapy; * The first relapse occurs within 12 months after first remission; * Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period. B) Minimal Residual Disease (MRD) positive T-ALL/LBL is defined as evidence of MRD, defined as \< 5% blasts in bone marrow but ≥ 1 cancer cell in 1,000 cells determined by NGS ClonoSEQ® and/or other regionally acceptable methodologies (e.g., EuroMRD guidelines). 4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening. 5. Adequate organ function 6. ECOG of 2 or less or Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening. Key Exclusion Criteria: 1. Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome. 2. Active central nervous system (CNS) involvement 3. Participants with following cardiac conditions will be excluded: 1. History of heart failure New York Heart Association (NYHA) class III or IV; 2. History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment. 4. Primary immune deficiency. 5. Presence of uncontrolled infections. 6. Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis. 7. Active or latent hepatitis B virus infection 8. Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.

Study sites (8)

CA

CO

IL

MN

NY

  • Memorial Sloan Kettering Cancer Center · New York, NY 11101Mark Geyer, MD · Study contactMore trials in New York
  • Montefiore Einstein Comprehensive Cancer Center · The Bronx, NY 10467Alex Sica, MD · Study contactMore trials in The Bronx

TN

TX