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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 (Jun 2026). This Phase 1 trial studies Senza5 CART5 for t cell non-hodgkin lymphoma.

Phase 1RecruitingVittoria BiotherapeuticsNCT06420089Data as of Jun 2026

Treatment: Senza5 CART5This 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.

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Extracted eligibility criteria

Treatments studied

Other

Senza5 CART5

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

Min 1 prior line

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 →

Frequently asked questions

Is NCT06420089 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chimeric antigen receptor therapy, autologous or syngeneic hematopoietic cell transplant, allogeneic hematopoietic cell transplant disqualifies patients from enrollment.

Does this trial require CD5?

Yes, CD5 overexpression is a required biomarker for enrollment.

Does this trial require CD5?

Yes, CD5 wild-type is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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