Treatment for relapsed or refractory B-cell non-Hodgkin lymphoma using dual-targeted cells
A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-G39D, a Dual-targeted Cell Preparation Targeting CD19/CD20, in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
This study is testing a new treatment called LUCAR-G39D to see if it can help adults with relapsed or hard-to-treat B-cell non-Hodgkin lymphoma feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 2 sites (Hefei, Anhui and 1 other locations) |
| Trial ID | NCT06395870 on ClinicalTrials.gov |
What this trial studies
This phase I, open-label clinical study evaluates the safety, tolerability, and efficacy of LUCAR-G39D, a dual-targeted cell preparation that targets CD19 and CD20, in patients aged 18 to 75 with relapsed or refractory B-cell non-Hodgkin lymphoma. Participants will undergo a screening phase followed by lymphodepleting chemotherapy before receiving a single dose of the LUCAR-G39D injection. The study will assess the treatment's effects through various phases, including follow-up to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed B-cell non-Hodgkin lymphoma that expresses CD19 or CD20 and has not responded to previous therapies.
Not a fit: Patients with non-B-cell lymphomas or those who have not undergone prior therapies 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 B-cell non-Hodgkin lymphoma.
How similar studies have performed: Other studies targeting CD19/CD20 have shown promise, indicating potential for success with this dual-targeted approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.
2. Aged 18-75 years (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
5. At least one evaluable tumor lesion according to Lugano 2014 criteria.
Response to prior therapy is consistent with one of the following:
1. Primary refractory.
2. Relapsed or refractory after 2 or more lines of therapy.
3. For LBCL, 3B FL. t-iNHL:
* Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
* Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;
7\. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria
Exclusion Criteria:
Subject eligible for this study must not meet any of the following criteria:
1\. Prior antitumor therapy with insufficient washout period ; 2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; 3. Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy; 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).
6\. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO.
7\. Pregnant or lactating women;
Where this trial is running
Hefei, Anhui and 1 other locations
- Oncology Department, The First Affiliated Hospital of USTC west district — Hefei, Anhui, China (Recruiting)
- Tianjin Cancer Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Huilai Zhang
- Email: huilaizhangtz@163.com
- Phone: +86-18622221228
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.