Overview

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

Status:
Recruiting
Trial end date:
2025-10-21
Target enrollment:
0
Participant gender:
All
Summary
This study is a multi-center, non-randomized, single-arm, open clinical trial.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hebei Senlang Biotechnology Inc., Ltd.
Collaborator:
Hebei Medical University Fourth Hospital
Treatments:
Cyclophosphamide
Fludarabine
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.