RecruitingPhase IEN originalLymphomaLeukemia

U69-CART-Cells For R/R T-ALL

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

Overall Introduction This single-arm, open-label clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CXCR4-enabled CCR9 chimeric antigen receptor T-cell injection (CXCR4 CCR9 CAR-T) in patients with relapsed or refractory T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL). Additionally, the study seeks to preliminarily assess the efficacy of CXCR4 CCR9 CAR-T cells and explore the appropriate dosage and administration schedule for subsequent Phase II clinical trials. A dose escalation study following the 3+3 design was implemented across three dose cohorts, with each cohort planned to enroll 3 to 6 patients, totaling 9 to 18 participants. Following cell infusion, subjects underwent safety and efficacy follow-up, which continued until 2 years post-infusion, subject withdrawal, or study termination-whichever occurred first. For subjects with available follow-up information after study completion or early termination, long-term follow-up-including long-term safety monitoring-was conducted for up to 15 years.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek od 15 do 75 lat w momencie podpisania zgody
  • •Potwierdzona diagnoza białaczki limfoblastycznej T nawrotowej lub opornej na leczenie
  • •Poprzednie standardowe terapie nie przyniosły efektu
  • •Co najmniej 5% nieprawidłowych komórek w szpiku lub we krwi (dla białaczki)
  • •Dla chłoniaka: co najmniej jeden widoczny guz o rozmiarze powyżej 15 mm
  • •Zdolność do uczestniczenia w badaniu przez 2 lata
  • •Świadoma zgoda pacjenta (lub rodzica dla osób poniżej 18 lat)
  • •Pacjent musi być w stanie ukończyć wszystkie procedury badania

Simplified criteria — AI translation

Trial details

Minimum age
15 Years
Maximum age
75 Years
Last updated (source)
September 2, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/3/2026.

You can help another person

We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.