Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05544968
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • CD30+ Anaplastic Large Cell Lymphoma
  • CD30+ Immunoblastic Large T-Cell Cutaneous Lymphoma
  • CD30+ Pleomorphic Large T-Cell Cutaneous Lymphoma
  • CD30-Positive Diffuse Large B-Cell Lymphoma
  • Hodgkin Disease
  • Leukemia
  • Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells (CD30 biAb-AATC) — DRUG
    anti-CD30 Bispecific Antibody-armed anti-CD3-Activated Autologous T-cells
  • GM-CSF — DRUG
    Hematopoietic agent that helps form white blood cells.

Study Details

This first-in-human trial will assess the safety, feasibility, and efficacy of an immunotherapy with a novel CD30 antibody conjugated to a CD3 antibody that is preloaded onto a patient's own T-cells, generating a CD30 bispecific antibody-armed, anti-CD3-activated, autologous T-cells (CD30 biAb-AATC).

Key Dates

Start date
Mar 4, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CD30biAb-AATC (Dose Level -1 -- 40 x 10^6 cells/kg/infusion + GM-CSF 250 μg/m^2)
    Patients will undergo weekly administration of dose escalating CD30 biAb-AATC infusions with twice weekly subcutaneous GM-CSF (250 μg/m\^2) in 4-week cycles for a maximum of two total cycles. A standard 3+3 dose escalation design will be utilized for this study.
  • Experimental: CD30biAb-AATC (Dose Level 1 -- 80 x 10^6 cells/kg/infusion + GM-CSF 250 μg/m^2)
    Patients will undergo weekly administration of dose escalating CD30 biAb-AATC infusions with twice weekly subcutaneous GM-CSF (250 μg/m\^2) in 4-week cycles for a maximum of two total cycles. A standard 3+3 dose escalation design will be utilized for this study.
  • Experimental: CD30biAb-AATC (Dose Level 2 -- 120 x 10^6 cells/kg/infusion + GM-CSF 250 μg/m^2)
    Patients will undergo weekly administration of dose escalating CD30 biAb-AATC infusions with twice weekly subcutaneous GM-CSF (250 μg/m\^2) in 4-week cycles for a maximum of two total cycles. A standard 3+3 dose escalation design will be utilized for this study.
  • Experimental: CD30biAb-AATC (Dose Level 3 -- 160 x 10^6 cells/kg/infusion + GM-CSF 250 μg/m^2)
    Patients will undergo weekly administration of dose escalating CD30 biAb-AATC infusions with twice weekly subcutaneous GM-CSF (250 μg/m\^2) in 4-week cycles for a maximum of two total cycles. A standard 3+3 dose escalation design will be utilized for this study.
  • Experimental: CD30biAb-AATC Recommended Phase 2 Dose (RP2D)
    The RP2D is defined as the dose level below the dose where two or more dose-limiting toxicities were observed.

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: 2 years ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]
  • Medical College of Wisconsin Cancer Center Clinical Trials Office, MD
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Guru Subramanian Guru Murthy, MD, MS
[email protected]
414-805-4600
Guru Subramanian Guru Murthy, MD, MS (PRINCIPAL_INVESTIGATOR)

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