IgPro20 in adults with immune deficiencies after CAR T-cell or T-cell redirecting therapies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, open-label study of IgPro20 given to adults with hematologic cancers who have developed secondary immune deficiency after CAR T-cell or T-cell redirecting therapy. It is a single-arm Phase 3 trial with two cohorts: a loading cohort for those with IgG below 500 mg/dL and a maintenance-only cohort for those with IgG 500 mg/dL or higher. The primary goal is to show that the annualized rate of serious bacterial infections is less than 1.0. Safety, efficacy, and pharmacokinetics are assessed over the treatment period. Eligible patients must have a documented response to CAR T-cell or TCE BsAb therapy and be adults receiving IgPro20 either currently or during prior treatment periods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants greater than or equal to (≥) 18 years of age at the time of providing written informed consent.
* Confirmed diagnosis of B-cell hematologic malignancy (ie, Multiple myeloma \[MM\], Chronic lymphocytic leukemia \[CLL\], Non-Hodgkin lymphoma \[NHL\], or BALL) according to applicable diagnostic criteria.
* Participants treated with Chimeric antigen receptor T-cell (CAR T-cell) therapy or TCE BsAb and are:

  1. At least 2 months after receipt of an approved CAR T-cell therapy for the B-cell hematologic malignancy at the time of Screening, or
  2. At least 1 month after initiation of an approved TCE BsAb therapy for the B-cell hematologic malignancy at the time of Screening and expected to continue with the therapy.
* Documented partial or complete response to CAR T-cell or TCE BsAb therapy based on applicable response criteria at the time of Screening:

  1. CLL based on International Workshop on Chronic Lymphocytic Leukemia response criteria
  2. MM based on International Myeloma Working Group response criteria
  3. NHL based on Lugano Classification criteria
  4. B-ALL based on National Comprehensive Cancer Network guidelines
* IgG level (excluding paraprotein, if relevant) at Screening:

If participant has ongoing IgRT (intravenous immunoglobulin \[IVIG\] or subcutaneous immunoglobulin \[SCIG\]) for SID during Screening, then any IgG level at Screening is acceptable for enrollment. Participants with IgG less than (\<) 500 milligrams per deciliter (mg/dL) are assigned to the Loading Cohort, participants with IgG ≥ 500 mg/dL are assigned to the Maintenance-only Cohort.

* IgG level (excluding paraprotein, if relevant) at Screening:

If participant does not have ongoing IgRT (IVIG for \> 8 weeks or SCIG for \> 2 weeks) for SID during Screening and are not expected to receive IgRT during Screening, then IgG \< 500 mg/dL is required for enrollment (participant is assigned to the Loading Cohort)

Exclusion Criteria:

* Documented history of diseases for which IgRT may be indicated: primary immune deficiency, chronic inflammatory demyelinating polyneuropathy, Guillain-Barré syndrome, immune thrombocytopenia, Kawasaki disease, Lambert-Eaton myasthenic syndrome, multifocal motor neuropathy, myasthenia gravis, stiff person syndrome, solid organ transplant, and rejection prior to Screening.
* History of thromboembolic event (TEE) within 6 months before Screening.
* Eastern Cooperative Oncology Group performance status \> 1.
* Presence of any systemic active infection at Screening.
* Participants on any prohibited therapies, including anti-infective treatments.
* Absolute neutrophil count \< 1 × 10\*9/L (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 3 or worse), unless proven to be due to the underlying disease and raised above the limit by granulocyte colony-stimulating factor.
* Concurrent participation in other interventional clinical studies. Note: a participant may be enrolled if their participation in the other study will not jeopardize their safety and / or the scientific validity of this study (eg, an observational study, a long-term safety follow-up of an interventional study, diagnostic device studies, phase 4 studies with medicines used within their approved indication); the investigator may consult with the medical monitor.

Where it's running

• SSAK Partners
  Coral Springs, Florida, United States Recruiting
• American Oncology Partners, PA dba The Center for Cancer and Blood Disorders
  Bethesda, Maryland, United States Recruiting
• UC Irvine
  Orange, California, United States Not yet recruiting
• CBCI, Colorado Blood Cancer Institute
  Denver, Colorado, United States Not yet recruiting
• Mayo Clinic - Jacksonville
  Jacksonville, Florida, United States Not yet recruiting
• Indiana University Health Arnett, Inc.
  Lafayette, Indiana, United States Not yet recruiting

+10 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Registration Coordinator
• Email: clinicaltrials@cslbehring.com
• Phone: +16108784697

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.