LP-168 + Obinutuzumab for Chronic Lymphocytic Leukemia

Overseen By UCCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Zulfa Omer

Must not be taking: Anticoagulants, Steroids, CYP3A4 inhibitors

Disqualifiers: Richter's transformation, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 months

34 Participants Needed

Trial Summary

What is the purpose of this trial?

Multicenter Parallel 2 Cohort Phase 2 Study of LP-168 and Obinutuzumab for Previously Treated, and T474 Gatekeeper Mutant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This.

Eligibility Criteria

This trial is for people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or similar conditions who have been treated before. It's specifically for those with a T474 mutation. The full eligibility criteria are not provided, so additional factors may apply.

Inclusion Criteria

Patients must have adequate organ and marrow function as defined below: ANC ≥1,000/mcL, unless if neutropenia is due to underlying CLL bone marrow disease. Platelets ≥ 50,000/ µL unless if thrombocytopenia is due to underlying CLL bone marrow disease then platelets of ≥20,000 is acceptable. Total bilirubin ≤1.5 x ULN (excepting Gilbert's syndrome, who may have a bilirubin > 1.5 × ULN, per discussion between the Investigator and the UC PI). AST and ALT ≤2.5 × ULN. Estimated glomerular filtration rate (by Modification of Diet in Renal Disease [MDRD] or Chronic Kidney Disease Epidemiology [CKD-EPI]) ≥ 30 mL/min.

I have CLL/SLL and have been treated with specific therapies or have a specific mutation.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

My condition has progressed to Richter's transformation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive LP-168 200 mg daily for 12 cycles, with obinutuzumab starting from cycle 7

12 months

Multiple visits per cycle

Response Evaluation

Response evaluation including labs, CT scan, and bone marrow biopsy after cycle 6

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 6 months

6 years

Biannual visits

Treatment Details

Interventions

• LP-168
• Obinutuzumab

Trial Overview The study tests LP-168 and Obinutuzumab in two separate groups of patients to see how well they work against CLL/SLL variants that have been previously treated, including those with the T474 mutation.

Participant Groups

Group I: Cohort 2 Experimental Treatment 2 Interventions

Cohort 2: Treatment with a prior BTKi (covalent and noncovalent) and have a BTK gatekeeper mutation in the T474 coordinate. prior treatment with BCL2 or chemotherapy will not exclude patients

Group II: Cohort 1 Experimental Treatment 2 Interventions

Cohort 1: One or more prior therapies for CLL/SLL including BCL2 inhibitor (BCL2i), and/or chemotherapy and/or BTK inhibitor (BTKi). • Note: Patients can be eligible if their CLL/SLL has been non-responsive to a covalent and noncovalent BTKi. Patients intolerant to BTKi whose disease becomes resistant to a second one are eligible to enroll. Prior treatment with CD20 will not be exclusionary.

Who Is Running the Clinical Trial?

Zulfa Omer

Lead Sponsor

Newave Pharmaceutical Inc

Industry Sponsor

Trials

4

Recruited

270+