Using CAR-T therapy for treating relapsed Hodgkin's lymphoma

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

This study is testing a new CAR-T cell therapy to see if it can help people with relapsed Hodgkin's lymphoma by targeting and attacking their cancer cells.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (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: NCT04665063 on ClinicalTrials.gov

What this trial studies

This multicenter clinical study evaluates the safety and effectiveness of CAR-T cell therapy in patients with relapsed or refractory Hodgkin's lymphoma. Participants will undergo a preconditioning treatment followed by the infusion of CAR-T cells, which are engineered to target and attack cancer cells. The study will monitor patients for adverse reactions and assess the efficacy of the treatment over time. It aims to provide insights into a novel therapeutic approach for a challenging cancer.

Who should consider this trial

Good fit: Ideal candidates are patients with relapsed or refractory Hodgkin's lymphoma who have exhausted standard treatment options.

Not a fit: Patients with early-stage Hodgkin's lymphoma or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new hope for patients with Hodgkin's lymphoma who have not responded to standard therapies.

How similar studies have performed: Other studies have shown promising results with CAR-T therapies in hematological malignancies, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visits, treatment plans, laboratory inspections, and other requirements of the research as specified in the test procedure;
2. Hodgkin lymphoma patients who are judged to be relapsed/refractory by clinical diagnosis, relapse or refractory are defined as:

   1. Primary resistance to standard treatment regimens;
   2. Or PD occurs after standard treatment with at least second-line standard treatment plan;
   3. Or the last treatment effect is SD and the duration does not exceed 6 months;
   4. Or after anti-PD-1 monoclonal antibody treatment is ineffective or relapses;
   5. Patients who have PD after autologous hematopoietic stem cell transplantation or confirmed recurrence by biopsy within 12 months, or patients who undergo salvage treatment after autologous hematopoietic stem cell transplantation have no remission or relapse after treatment.
3. According to RECIST version 1.1 , there should be at least one measurable tumor;
4. Subjects whose physical status scored by the Eastern Cooperative Oncology Group (ECOG) is 0\~2;
5. 14 years old ≤ age ≤ 75 years old, both male and female;
6. Immunohistochemistry or flow cytometry detects tumor cells as CD30 or CD19/CD22/CD79 positive;
7. The estimated survival period from the date of signing the informed consent form is greater than 3 months;
8. Laboratory examinations meet the following conditions: hemoglobin ≥80g/L, platelet count ≥50 × 109/L, absolute neutrophil count (ANC) ≥1.0 × 109/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 functions need to meet the following conditions: serum creatinine ≤1.5 ULN, AST (aspartate aminotransferase)/ALT (alanine aminotransferase)/ALP (alkaline phosphatase) ≤2.5 ULN, total bilirubin ≤1.5 ULN, left Ventricular ejection fraction (LVEF) ≥50%, and minimum lung function reserve (dyspnea is not higher than level 1 and blood oxygen saturation is greater than 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 Hodgkin's Lymphoma