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
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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

First listed
Sep 19, 2022
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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