Testing a new drug for certain types of blood cancers
A Phase 1/1b Open-Label Dose-Escalation and Dose-Optimization Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies
This study is testing a new drug for people with certain types of blood cancers to see how safe it is and what the best dose is.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BeiGene Industry-sponsored |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 22 sites (Waukee, Iowa and 21 other locations) |
| Trial ID | NCT05828589 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of BGB-21447, a Bcl-2 inhibitor, in patients with relapsed or refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia. It aims to determine the maximum tolerated dose, maximum administered dose, recommended Phase 2 dose, and the pharmacokinetic profile of the drug. The study is divided into two parts: the first focuses on finding the optimal dose for monotherapy, while the second optimizes this dose based on initial findings.
Who should consider this trial
Good fit: Ideal candidates include individuals with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukemia who meet specific diagnostic criteria.
Not a fit: Patients with prior malignancies (other than the disease under study) or certain high-grade lymphomas may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat blood cancers.
How similar studies have performed: Other studies have shown promise with Bcl-2 inhibitors in treating similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria
1. Confirmed diagnosis (per World Health Organization \[WHO\] guidelines, unless otherwise noted) of one of the following:
Cohort A1 and Cohort A2:
1. R/R DLBCL (for Cohort A1 and Cohort A2.1)
* High-grade B-cell lymphomas with translocations of MYC and Bcl-2 and/or Bcl-6 are not allowed in Cohort A1 but may be allowed in Cohort A2.1
2. R/R FL (for Cohort A1 and Cohort A2.2)
3. R/R MZL (for Cohort A1 and Cohort A2.2)
4. Transformed B-cell NHL (for Cohort A1 only)
5. Richter's transformation to DLBCL (for Cohort A1 only)
2. Measurable disease by computed tomography/magnetic resonance imaging.
Exclusion Criteria:
1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer or lentigo maligna melanoma that has been curatively resected
2. Known central nervous system involvement by lymphoma/leukemia
3. Prior autologous stem cell transplant \< 3 months before the first dose of study drug. Or prior chimeric antigen receptor T-cell (CAR-T) therapy \< 3 months before the first dose of study drug
4. Prior allogeneic stem cell transplant.
5. Major surgery \< 4 weeks before the first dose of study treatment
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Waukee, Iowa and 21 other locations
- Mission Cancer and Blood — Waukee, Iowa, United States (Not_yet_recruiting)
- Sidney Kimmel Comprehensive Cancer At Johns Hopkins — Baltimore, Maryland, United States (Not_yet_recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Avera Cancer Institue — Sioux Falls, South Dakota, United States (Not_yet_recruiting)
- Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (Recruiting)
- Pindara Private Hospital — Benowa, Queensland, Australia (Recruiting)
- Monash Health — Clayton, Victoria, Australia (Recruiting)
- Linear Clinical Research — Nedlands, Western Australia, Australia (Recruiting)
- Peking University Third Hospital — Beijing, Beijing, China (Recruiting)
- Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
- Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
- Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
- The First Affiliated Hospital of Nanchang University Branch Donghu — Nanchang, Jiangxi, China (Recruiting)
- The First Affiliated Hospital of Nanchang University Branch Xianghu — Nanchang, Jiangxi, China (Recruiting)
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
- Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)
- Linyi Peoples Hospital — Linyi, Shandong, China (Recruiting)
- Affiliated Zhongshan Hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)
- Institute of Hematology and Hospital of Blood Disease — Tianjin, Tianjin, China (Recruiting)
- Auckland City Hospital — Auckland, New Zealand (Recruiting)
Study contacts
- Study coordinator: Study Director
- Email: clinicaltrials@beigene.com
- Phone: +1-877-828-5568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.