A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)

• ClinicalTrials.gov Identifier: NCT05512390
• Recruitment Status: Recruiting
• First Posted: August 23, 2022
• Last Update Posted: March 5, 2024
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: August 22, 2022
• First Posted Date: August 23, 2022
• Last Update Posted Date: March 5, 2024
• Actual Study Start Date: April 26, 2023
• Estimated Primary Completion Date: February 7, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 22, 2022)

• Number of Dose-Limiting Toxicities (DLT) [ Time Frame: Day 21 ]
  A DLT is defined as any adverse event (AE) for which a clear alternative cause cannot be established (eg, attributed to the disease under study, another disease, or to a concomitant medication by the study investigators or medical monitor).
• Number of Participants with Adverse Events (AE) [ Time Frame: Up to 30 Months ]
  AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
• Maximum Observed Serum Concentration (Cmax) of ABBV-319 [ Time Frame: Up to 6 Months ]
  Maximum observed serum concentration of ABBV-319.
• Time to Cmax (Tmax) of ABBV-319 [ Time Frame: Up to 6 Months ]
  Time to Cmax of ABBV-319.
• Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 [ Time Frame: Up to 6 Months ]
  Terminal phase elimination half-life of ABBV-319.
• Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319 [ Time Frame: Up to 6 Months ]
  Area under the serum concentration versus time curve (AUC) of ABBV-319.
• Antidrug Antibody (ADA) [ Time Frame: Up to 6 Months ]
  Incidence and concentration of anti-drug antibodies.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 22, 2022)

• Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria [ Time Frame: Up to 6 Months ]
  Number of participants with response of PR or better per disease-specific criteria.
• Duration of Response (DOR) [ Time Frame: Up to 6 Months ]
  DOR is defined for participants achieving a complete response (CR)/PR as the time from the initial response per investigator review to disease progression or death of any cause, whichever occurs earlier.
• Time to Response [ Time Frame: Up to 6 Months ]
  Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.
• Progression Free Survival (PFS) Time [ Time Frame: Up to 30 Months ]
  PFS is defined as time from first study treatment to a documented disease progression as determined by the investigator, or death due to any cause, whichever occurs earlier.
• Overall survival (OS) Time [ Time Frame: Up to 30 Months ]
  OS is defined as time from first study treatment to death due to any cause.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)
• Official Title: A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies

Brief Summary

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed.

ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the recommended Phase 2 dose (RP2D) of ABBV-319 and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 114 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide.

In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the recommended Phase 2 dose is determined. In the dose expansion phase of the study participants receive intravenously infused ABBV-319 in 21-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Diffuse Large B-Cell Lymphoma
• Chronic Lymphocytic Leukemia
• Follicular Lymphoma

Intervention

Drug: ABBV-319

Intravenous (IV); Infusion

Study Arms

• Experimental: Dose Escalation ABBV-319
  Participants with relapsed or refractory (R/R) B cell lymphomas including diffuse large b-cell lymphoma (DLBCL) or follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) will receive escalating doses of ABBV-319 in 21-day cycles, until the recommended Phase 2 dose (RP2D) is determined.
  Intervention: Drug: ABBV-319
• Experimental: (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants
  Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.
  Intervention: Drug: ABBV-319
• Experimental: (ABBV-319) Follicular Lymphoma (FL) Participants
  Participants with R/R FL will receive ABBV-319 in 21-day cycles.
  Intervention: Drug: ABBV-319
• Experimental: (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants
  Participants with R/R CLL will receive ABBV-319 in 21-day cycles.
  Intervention: Drug: ABBV-319

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 22, 2022): 114
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 7, 2027
• Estimated Primary Completion Date: February 7, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• For dose escalation (Part 1) only: Participants with documented diagnosis of B-cell malignancies including those with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment, as per the protocol.
• For the relapsed or refractory diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) dose expansion cohorts (Part 2) only: Participants with documented diagnosis of one of the B-cell malignancies noted in the protocol with histology based on criteria established by the WHO, and measurable disease requiring treatment, as per the protocol.
• Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Laboratory values meeting the criteria noted in the protocol.
• For participants previously treated with a CD19-targeting therapy (eg, CD19 monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD19-targeting therapy must be collected.
• Participant must have measurable disease, as defined by the 2014 Lugano Classification.

Exclusion Criteria:

• Known active central nervous system (CNS) disease, or primary CNS lymphoma.
• Know active infection or clinically significant uncontrolled conditions as per the protocol.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: ABBVIE CALL CENTER; 844-663-3742; abbvieclinicaltrials@abbvie.com

• Listed Location Countries: Australia, Canada, Israel, United States

Administrative Information

• NCT Number: NCT05512390
• Other Study ID Numbers: M22-716
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: March 2024