Using CAR-T therapy to treat relapsed or refractory Non-Hodgkin's Lymphoma

A Multicenter Clinical Study on the Safety and Efficacy of CAR-T in the Treatment of Relapsed / Refractory Non Hodgkin's Lymphoma

This study is testing whether CAR-T therapy can help people with relapsed or hard-to-treat Non-Hodgkin's Lymphoma by using their own immune cells to fight the cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 14 Years to 75 Years
• Sex: All
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT04666168 on ClinicalTrials.gov

What this trial studies

This multicenter clinical trial evaluates the safety and efficacy of CAR-T cell therapy in patients with relapsed or refractory Non-Hodgkin's Lymphoma (NHL). The study includes various subtypes of NHL, such as highly aggressive and invasive forms, and involves preconditioning treatment followed by CAR-T cell infusion. Participants will be monitored for adverse reactions and treatment efficacy throughout the trial. The approach aims to harness the patient's own immune cells to target and eliminate cancer cells more effectively.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with relapsed or refractory Non-Hodgkin's Lymphoma who have not responded to standard treatments.

Not a fit: Patients with Non-Hodgkin's Lymphoma that is not relapsed or refractory may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients with difficult-to-treat forms of Non-Hodgkin's Lymphoma.

How similar studies have performed: Other studies using CAR-T therapy for similar conditions have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visit, treatment plan, laboratory examination and other requirements of the study specified in the test flow sheet; 2. Patients with hematopoiesis and lymphoid tissue tumors diagnosed as relapsed and refractory by clinical diagnosis were defined as relapse or refractory

1. Primary drug resistance to standard treatment regimen;
2. Or PD occurred after at least second-line standard treatment;
3. Or the last treatment effect was SD and lasted no more than 6 months;
4. Or CD20 positive patients were ineffective or relapsed after anti-CD20 mAb treatment;
5. Or PD after autologous hematopoietic stem cell transplantation, or recurrence confirmed by biopsy within 12 months, or salvage treatment after autologous hematopoietic stem cell transplantation has no remission or recurrence after treatment.

   3. According to RECIST version 1.1 , there should be at least one measurable tumor focus; 4. Subjects with ECoG score of 0-2 5. 14 years old ≤ age ≤ 75 years old, both male and female; 6. The tumor cells were positive for CD19 or CD22 / CD30 / CD7 / CD79 by immunohistochemistry or flow cytometry; 7. The expected survival time is more than 3 months from the date of signing the informed consent； 8. Laboratory examinations meet the following conditions: hemoglobin ≥80g/L, platelet count ≥50 × 10\^9/L, absolute neutrophil count (ANC) ≥1.0 × 10\^9/L, if the investigator believes that the above inspection value is below the lower limit It is caused by tumor invading bone marrow and can be included in the group after consultation with the sponsor; 9. The main organ function indicators meet the following conditions: AST (aspartate aminotransferase)/ALT (alanine aminotransferase)/ALP (alkaline phosphatase) ≤2.5 ULN, serum creatinine ≤1.5 ULN, total bilirubin ≤1.5 ULN, left Ventricular ejection fraction (LVEF) ≥50%, and minimum pulmonary function reserve (dyspnea is not higher than level 1 and blood oxygen saturation\> 92% under indoor conditions).

   Exclusion Criteria:
   1. Severe cardiac insufficiency, left ventricular ejection fraction \<50%;
   2. There is a history of severe lung dysfunction diseases;
   3. The patient has had other malignant tumors in the past 5 years, except for skin basal cell carcinoma, breast carcinoma in situ and cervical carcinoma in situ that have undergone radical treatment;
   4. Combined with severe or persistent infection and cannot be effectively controlled; Severe infection: Refers to sepsis or uncontrolled infection of the infected foci, and can be included in the group after infection is controlled
   5. Combined metabolic diseases (except diabetes);
   6. Combined with severe autoimmune disease or innate immune deficiency;
   7. Untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen \[HBsAg\] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody \[ HCV-Ab\] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined with hepatitis B and C co-infection;
   8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
   9. A history of severe allergies to biological products (including antibiotics);
   10. Participate in any other clinical drug trials at the same time within one month;
   11. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the research, or interfere with the results of the research, and patients who the researcher believes are not suitable for participating in this research.

Where this trial is running

Shijiazhuang, Hebei

• Hematology Department, Hebei Medical University Fourth Hospital — Shijiazhuang, Hebei, China (Recruiting)

Study contacts

• Principal investigator: Baoen Shan, PhD & MD — Hebei Medical University Fourth Hospital
• Study coordinator: Jianqiang Li, PhD & MD

Conditions Non-hodgkin's Lymphoma; NHL