CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)

Conditions

• T Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Senza5 CART5 — DRUG
  The Senza5 CART5 drug product consists of a dual population of engineered autologous T cells: CD5 knockout (KO)cells and CD5KO-CART5 cells

Study Details

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.

Key Dates

Start date

Oct 4, 2024

Status verified

Jul 2025

Primary completion

Aug 30, 2028

Completion

Aug 30, 2029

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Senza5 CART5 with standard of care lymphodepletion
  Four treatment arms with Standard of Care Lymphodepletion: Fludarabine 25mg/m2 IV for 3 days Cyclophosphamide 250mg/m2 IV for 3 days
• Experimental: Senza5 CART5 without standard of care lymphodepletion
  Four treatment arms in patients are lymphopenic into the corresponding dose level.

Primary Outcome Measure

Determine the recommended phase 2 dose (RP2D) of Senza5 CART5 cells [ Time Frame: 12 months ]

Central Contacts

• Vittoria Biotherapeutics
  (215) 600-1380
  [email protected]

Locations (2)

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