OncoMatch/Clinical Trials/NCT06420089
CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)
Is NCT06420089 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Senza5 CART5 for t cell non-hodgkin lymphoma.
Treatment: Senza5 CART5 — This is an open-label phase I study to determine the safety and recommended phase 2 dose (RP2D) of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL. RP2D will be based on the safety, tolerability, pharmacokinetics, and preliminary efficacy of Senza5 CART5 cells. This trial will evaluate up to 5 dose levels using the Bayesian Optimal Interval (BOIN) design enrolling 3 patients in each cohort to assess safety and achieve therapeutic levels so that the RP2D of Senza5 CART5 cells given as a single IV infusion can be determined.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD5 overexpression (≥50% expression on malignant cells by flow cytometry or IHC)
≥50% expression of CD5 on flow cytometry or IHC on malignant cells on the most recent biopsy
Required: CD5 wild-type (No circulating CD5+ malignant cells by peripheral blood flow cytometry)
No circulating CD5+ malignant cells identified by peripheral blood flow cytometry must be present.
Prior therapy
Must have received: systemic therapy — for lymphoma
Must have received at least one line of prior systemic therapy for their lymphoma
Must have received: antibody-drug conjugate (brentuximab) — for anaplastic large cell lymphoma (ALCL)
participants with anaplastic large cell lymphoma (ALCL) must have received prior brentuximab unless there was a contraindication to brentuximab
Cannot have received: chimeric antigen receptor therapy
History of prior chimeric antigen receptor therapy (CAR T)
Cannot have received: autologous or syngeneic hematopoietic cell transplant
Exception: if <100 days from transplant at the time of cell infusion
autologous or syngeneic HCT <100 days from transplant at the time of cell infusion
Cannot have received: allogeneic hematopoietic cell transplant
previous allo-HCT
Cannot have received: monoclonal antibody therapy
Exception: if within 4 weeks prior to study Day 1
Prior monoclonal antibody therapy within 4 weeks prior to study Day 1
Cannot have received: anti-CD52 antibody (alemtuzumab)
Prior use of alemtuzumab
Cannot have received: chemotherapy
Exception: if within 2 weeks prior to study Day 1
Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
Cannot have received: targeted small molecule therapy
Exception: if within 2 weeks prior to study Day 1
Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
Cannot have received: radiation therapy
Exception: if within 2 weeks prior to study Day 1
Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Columbia University Irving Medical Center · New York, New York
- University of Pennsylvania - Abramson Caner Center · Philadelphia, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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