Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/NHL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3-70
SponsorPeking University People's Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Epilepsy
Paralysis
Aphasia
Stroke
Trial design
Design model
Single group
Treatments tested in this trial
CD5-targeted CAR-T cells
Biological/VaccinePhase I: Eligible patients will receive a single infusion of CD5-targeted CAR-T cells at one of three dose levels (0.5 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, or 2.0 × 10⁶ cells/kg) following fludarabine and cyclophosphamide (FC) lymphodepleting chemotherapy. A 3+3 dose-escalation design will be used to determine the recommended Phase II dose (RP2D) based on safety, dose-limiting toxicities (DLTs), and preliminary efficacy. Phase II: Patients will receive CD5-targeted CAR-T cells at the RP2D following FC lymphodepleting chemotherapy.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: CD5-targeted CAR-T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
DLT (Dose-Limiting Toxicity)
CRS and ICANS will be assessed per ASTCT (2019), while other AEs follow CTCAE v5.0. DLTs are CAR-T-related AEs that occur within 28 days post-infusion and meet the following criteria: Grade 4+ CRS, or Grade 3 CRS unresolved to ≤ Grade 2 within 7 days. Grade 3+ non-hematologic toxicity unresolved to ≤ Grade 2 within 7 days. Grade 4+ ICANS, or Grade 3 ICANS unresolved to ≤ Grade 2 within 3 days. Grade 3+ hypersensitivity reaction. Any unexpected toxicity requiring study discontinuation. Exemptions: Rapid hypersensitivity resolving to ≤ Grade 2 in 2 hours. Reversible Grade 3 AEs lasting ≤7 days. Transient CRS-related organ dysfunction, resolving in ≤7 days per SRC. All DLTs are reviewed by the Safety Review Committee (SRC).
Time frame
Day28 after CAR-T cell infusion2
Overall Response Rate (ORR)
ORR is defined as the proportion of patients achieving Complete Remission (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), or Morphologic Leukemia-Free State (MLFS) per European LeukemiaNet (ELN) 2022 for T-ALL and Lugano/Lyric 2016 for T-NHL. CR: \<5% blasts in bone marrow, no circulating blasts/extramedullary disease, ANC \>1.0 × 10⁹/L, platelets \>100 × 10⁹/L, MRD-negative. CRi: Meets CR but lacks full hematologic recovery. MLFS: \<5% blasts, no hematologic recovery required. Lugano 2016 (T-NHL): CR = complete metabolic response on PET-CT; PR = ≥50% tumor reduction.
Time frame
Within 3 months after CAR-T cell infusionSecondary outcomes
1
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from the date of first documented Complete Remission (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), or Morphologic Leukemia-Free State (MLFS) until the date of bone marrow (BM) or peripheral blood (PB) relapse, extramedullary disease (EMD) progression, or death from any cause, whichever occurs first. PFS will be assessed according to European LeukemiaNet (ELN) 2022 criteria for T-ALL and Lugano/Lyric 2016 criteria for T-NHL.
Time frame
Within 2-year after CAR-T cell infusion2
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of CD5-targeted CAR-T cell infusion until death from any cause. Patients alive at the time of analysis will be censored at the date of last follow-up.
Time frame
Within 2-year after CAR-T cell infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University People's Hospital
Lead sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborator
Source ClinicalTrials.gov