Clinical Trials

Several clinical trials are evaluating MALT1 inhibitors and associated interventions across hematologic malignancies and cardiorespiratory failure. Industry sponsors, including AbbVie and Janssen Research & Development, LLC, have initiated Phase 1 studies targeting B-cell malignancies, diffuse large B-cell lymphoma, chronic lymphocytic leukemia, and non-Hodgkin's lymphoma, with recruitment statuses ranging from active, not recruiting to completed. Additionally, an academic sponsor, Istituti Clinici Scientifici Maugeri SpA, is recruiting for a study marked as phase not applicable to evaluate patient physical activity in cardiorespiratory failure.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05618028 ACTIVE_NOT_RECRUITING
Diffuse Large B-Cell Lymphoma; Chronic Lymphocytic Leukemia; B Cell Malignancies; Non-Hodgkin's Lymphoma
AbbVie
 2023-04-04 PHASE1
NCT04876092 COMPLETED
Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin
Janssen Research & Development, LLC
 2021-07-28 PHASE1
NCT05318482 Recruiting
Cardiorespiratory Failure
Istituti Clinici Scientifici Maugeri SpA
 2022-03-23 Not Applicable

(data from https://clinicaltrials.gov, updated on 2026-05-04)

Check the MI-2 (MALT1 inhibitor) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MI-2 acts as an irreversible inhibitor of mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1), binding the enzyme to block its protease activity and impair downstream nuclear factor kappa B (NF-κB) signaling. This disruption of oncogenic signal transduction suppresses lymphocyte proliferation and induces apoptosis, conferring clinical relevance for targeted therapy in B-cell malignancies such as diffuse large B-cell lymphoma and non-Hodgkin's lymphoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.