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BCL-2 inhibitor

CC-99282 + Obinutuzumab for Chronic Lymphocytic Leukemia

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Subject is ≥18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

Study Summary

This trial is testing a new drug combo to treat CLL/SLL.

Who is the study for?

Adults over 18 with relapsed or refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma who've had at least two prior treatments, including a BTK inhibitor. They must have measurable disease, adequate organ function, and no recent history of certain other cancers or treatments like CAR-T therapy.Check my eligibility

What is being tested?

The trial is testing the safety and early effectiveness of CC-99282 combined with Obinutuzumab in patients whose CLL/SLL has come back or didn't respond to treatment. It's an early-phase study that gradually increases doses to find safe levels.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to the immune system due to Obinutuzumab, as well as any risks associated with new drug CC-99282 which will be monitored closely during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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My condition did not improve after 2+ treatments, including a BTK inhibitor.

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My spleen is enlarged, measuring at least 14 cm long.

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My kidneys are functioning well.

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I am able to get out of my bed or chair and move around.

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My liver is enlarged, measuring at least 20 cm in length.

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I have been diagnosed with CLL/SLL and need treatment.

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I have CLL/SLL that needs treatment and measurable signs of the disease.

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My white blood cell count is within the required range without medication help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events (AEs)

Dose Limiting Toxicity (DLT)

Maximum tolerated dose (MTD)

Secondary outcome measures

Complete response with incomplete marrow recovery (CRi)

Duration of response (DoR)

Nodular partial response (nPR)

+11 more

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619

100%

Platelet count decreased

100%

Neutrophil count decreased

100%

Hypotension

100%

Fatigue

50%

Bone pain

50%

Oral pain

50%

Anaemia

50%

Diarrhoea

50%

Tremor

50%

Lymphocyte count decreased

50%

Oedema peripheral

50%

Pyrexia

50%

Cytokine release syndrome

50%

Insomnia

50%

White blood cell count decreased

50%

Headache

50%

Nausea

50%

Muscular weakness

100%

80%

60%

40%

20%

Study treatment Arm

Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)

Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)

Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)

Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)

Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Trial Design

1Treatment groups

Experimental Treatment

Group I: CC-99282 + obinutuzumabExperimental Treatment2 Interventions

Escalating doses of CC-99282 administered orally once daily on intermittent schedules with obinutuzumab IV infusion 1000 mg up to 2 years in Part A. CC-99282 administered orally once daily at MTD or alternative tolerating dosing schedule with obinutuzumab IV infusion 1000 mg up to 2 years in Part B.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC-99282

2017

Completed Phase 2

~70

Obinutuzumab

2015

Completed Phase 3

~3250

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,921 Total Patients Enrolled

Poliana Patah, MD, PhDStudy DirectorBristol-Myers Squibb

1 Previous Clinical Trials

438 Total Patients Enrolled

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,506 Previous Clinical Trials

3,369,480 Total Patients Enrolled

Media Library

CC-99282 (BCL-2 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04434196 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: CC-99282 + obinutuzumab

Non-Hodgkin's Lymphoma Clinical Trial 2023: CC-99282 Highlights & Side Effects. Trial Name: NCT04434196 — Phase 1

CC-99282 (BCL-2 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04434196 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has CC-99282 been accorded regulatory acceptance by the Food and Drug Administration?

"Judging by the limited data on CC-99282's efficacy and safety, our team gave it a score of 1."

Answered by AI

Is this research pioneering a new methodology?

"CC-99282 has been under scrutiny since 2014, when Genentech Inc. sponsored a preliminary study involving 40 patients. After successfully completing Phase 1 & 2 trials, CC-99282 is now being researched in over 100 clinical studies throughout 948 cities and 46 nations around the world."

Answered by AI

Has CC-99282 been tested through previous research investigations?

"CC-99282 was first tested at UCSD Moores Cancer Center in 2014, with 55 trials having completed thus far. Currently, there are numerous live studies using this drug being conducted across Montreal, Quebec alone."

Answered by AI

To what capacity is this clinical trial accepting new participants?

"Indeed, the clinical trial is presently recruiting. According to records stored on clinicaltrials.gov, it was first posted on December 21st 2020 and most recently modified on October 11th 2022. This study needs to recruit a total of 50 individuals from 9 distinct sites for participation."

Answered by AI

How many venues are currently hosting this research effort?

"Patients can find enrolment opportunities at Sir Mortimer B. Davis - Jewish Genl in Montreal, Quebec; Dana Farber Cancer Institute in Boston, Massachusetts; University of Cincinnati Medical Center in Cincinnati, Ohio and an additional 9 sites."

Answered by AI

What is the primary goal of this clinical investigation?

"The purpose of this 28-day cycle research is to assess Dose Limiting Toxicity. Secondary metrics include Apparent volume of distribution during terminal phase after non-intravenous administration, Terminal-phase elimination half-life and Pharmacokinetics - V/F."

Answered by AI

Is this trial still taking on new participants?

"According to clinicaltrials.gov, the current iteration of this research project is still recruiting participants. The trial first launched on December 21st 2020 and was recently updated on October 11th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

2020. "A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04434196.

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