RecruitingPhase 1/2

Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/NHL

China30 participantsStarted 2025-02-14

Plain-language summary

To observe the safety and efficacy of Nanobody-Based CD5-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed T-ALL/NHL

Who can participate

Age range3 Years – 70 Years

SexALL

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Inclusion criteria

✓. The subject or guardian understands and voluntarily signs the informed consent form (ICF).
✓. Male or female, aged 3-70 years at the time of signing the ICF (inclusive).
✓. Expected survival of at least 12 weeks.
✓. ECOG performance status of 0-2 at the time of ICF signing.
✓. Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia/lymphoma (R/R T-ALL/NHL) confirmed at screening and meeting at least one of the following criteria:
✓. Bone marrow involvement: Morphologic examination shows ≥5% lymphoblasts, and/or
✓. Cerebrospinal fluid (CSF) involvement: Tumor cells detected in CSF, and/or
✓. Extramedullary disease: Presence of measurable lesions (lymph node/mass ≥1.5 cm in axial diameter or extranodal lesion ≥1 cm in axial diameter).

Exclusion criteria

✕. History of central nervous system (CNS) diseases, including but not limited to:
✕. History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to signing the ICF, including but not limited to:
✕. Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to apheresis that requires antibiotic, antiviral, or antifungal treatment.
✕. Positive virological or infectious disease markers, including:
✕. Clinically significant cardiovascular diseases, including any of the following:
✕. QTc interval ≥480 ms (Fridericia correction formula)
✕. New York Heart Association (NYHA) Class II or higher heart failure
✕. Unstable angina or acute myocardial infarction within 6 months prior to signing the ICF

What they're measuring

DLT (Dose-Limiting Toxicity)

Timeframe: Day28 after CAR-T cell infusion

Overall Response Rate (ORR)

Timeframe: Within 3 months after CAR-T cell infusion

Trial details

NCT IDNCT06874946

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

MENG LV, MD PhD

+861088324637 drlvmeng@bjmu.edu.cn

View on ClinicalTrials.gov More Precursor T-Cell Lymphoblastic Leukemia-Lymphoma trials