RecruitingPhase I/IIEN original

Allogenic CD19-targeting CAR-γδT Cell Therapy in R/R NHL

⚠️

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

This is a single center, prospective, open-label, single-arm, phase 1/2 study for patients with r/r B-cell NHL to evaluate the safety and efficacy of gene edited allogenic CD19 CAR-γδT cells. The cells are from healthy adult volunteer donors that are gene edited ex vivo using CRISPR-Cas9 to weaken HLA expression and further to overcome host immune system rejection (HvGR). In this study, a second generation anti-CD19 CAR prototype was constructed, bearing murine FMC63 single-chain variant fragment (scFv) together with intracellular 4-1BB co-stimulatory and CD3ζ signaling domains linked by a CD8α sequence comprising the hinge and transmembrane domains. This upgraded version of the CAR-γδT product will be used in this study after March 20th, 2024. A total of around 30 patients with r/r B-cell NHL will be enrolled in the study and receive allogeneic CD19 CAR-γδT cell infusion. Phase 1 (n=9 to 12) is dose escalation part, and phase 2 (n=15 to 20) is expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of allogeneic CD19 CAR-γδT cell therapy in patients with r/r B-cell NHL.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek 18-75 lat
  • •Potwierdzony histologicznie chłoniak nieziarniczy B-komórkowy dodatni na CD19
  • •Nawrót choroby po co najmniej 2 liniach leczenia lub brak odpowiedzi na leczenie pierwszego stopnia
  • •Dla agresywnych typów chłoniaka: nawrót po pierwszym leczeniu lub brak odpowiedzi na pierwsze leczenie
  • •Dla chłoniaka płaszcza: poprzednie leczenie zawierające chemioterapię
  • •Zaawansowana lub uogólniona choroba

Simplified criteria — AI translation

Trial details

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

Therapies / drugs in trial

Locations (2)

School of phamaceutical, Tsinghua University

Beijing, China

Biotherapeutic Department, Chinese PLA General Hospital

Beijing, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/16/2026.

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