Using engineered T cells and BTK inhibitors to treat B cell lymphoma
Efficacy and Safety of Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma：a Single-center, Open-label, Pragmatic Clinical Trial
This study is testing if adding BTK inhibitors to a special type of immune cell treatment can help people with hard-to-treat B cell lymphoma feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Wuhan Union Hospital, China Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, CART, chimeric antigen receptor, ibrutinib, Zanubrutinib, Orelabrutinib |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05020392 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of anti-CD19 CAR-modified T cells combined with BTK inhibitors in patients with relapsed or refractory B cell lymphoma. The study involves a single-center, open-label design and aims to determine if the addition of BTK inhibitors like Ibrutinib, Zanubrutinib, and Orelabrutinib can enhance the treatment outcomes of CAR-T cell therapy. Eligible participants are those who have previously failed at least one line of therapy for their B cell malignancies. The trial will assess both the effectiveness and safety of this combined therapeutic approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with CD19+ B cell lymphoma who have failed at least one prior therapy.
Not a fit: Patients with gastrointestinal lymph node or central nervous system involvement may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with difficult-to-treat B cell lymphomas.
How similar studies have performed: Other studies have shown promising results with similar CAR-T cell therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Aged ≥ 18 years and ≤70 years.
2. Expected survival over 6 months.
3. Eastern Cooperative Oncology Group score≤ 2.
4. Diagnosed pathologically and histologically CD19+B cell lymphoma, including mantle cell lymphoma, chronic lymphocytic leukemia, follicular cell lymphoma, Burkitt lymphoma and diffuse large B cell lymphoma.
5. Patients have failed at least 1 line of prior therapy
6. Negativity of blood pregnancy test for woman, and participants use effective methods of contraception until last follow-up.
7. Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
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Exclusion Criteria:
1. Investigators judge the patients with gastrointestinal lymph node and/or central nervous system involvement who may be at high-risk of receiving CAR-T-CD19 cell treatment.
2. Existing or preexisting CNS conditions, such as epileptic seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS related autoimmune diseases.
3. Patients with graft-versus-host reaction and need immunosuppressive agents, or patients with autoimmune diseases.
4. Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within five years.
5. History of Richter's syndrome.
6. History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.
7. Patients who are pregnant or breast-feeding.
8. Patients with any one of the following terms:
A. Creatine \>2.5mg/dl (221.0umol/L). B. Alanine aminotransferase/aspartate aminotransferase \>3 times the upper limit of normal (ULN).
C. Total bilirubin\>2.0 mg/dl (34.2umol/L).
9. Major surgery within 4 weeks of randomization.
10. Systemic steroids are used within 2 weeks before apheresis (Except for those who are using inhaled steroids recently or currently).
11. Patients receive cytotoxic chemotherapy or radiotherapy within 21 days before enrollment (Tyrosine kinase inhibitors or other targeted therapies can be used two weeks before lymphodepleting chemotherapy).
12. Prior treatment with any gene therapy product.
13. Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection.
14. Systemic fungal, bacterial, viral, or other infection that is not controlled.
15. The absolute value of lymphocytes was too low to manufacture CAR-T cells.
16. Other conditions considered inappropriate by the researcher.
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Where this trial is running
Wuhan, Hubei
- Union Hospital, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Yu Hu — Wuhan Union Hospital, China
- Study coordinator: Heng Mei
- Email: hmei@hust.edu.cn
- Phone: 027-8572600
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.