Using CAR-T therapy to treat relapsed or refractory plasma cell tumors

Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Plasma Cell Tumors

This study is testing if a new CAR-T therapy can help people with tough-to-treat plasma cell tumors feel better and fight their cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (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: NCT04665076 on ClinicalTrials.gov

What this trial studies

This multicenter clinical trial evaluates the safety and effectiveness of CAR-T cell therapy in patients with relapsed or refractory plasma cell tumors. 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 the potential of CAR-T therapy for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates include patients with relapsed or refractory plasma cell tumors who have not responded to standard treatments.

Not a fit: Patients with early-stage plasma cell tumors or those who have not undergone prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat plasma cell tumors.

How similar studies have performed: Other studies have shown promising results with CAR-T therapy in various hematological malignancies, suggesting potential success for this approach in plasma cell tumors.

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. Patients with relapsed/refractory plasma cell tumors determined by clinical diagnosis;

   The definition of relapsed/refractory plasma cell tumors is:
   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 treatment with proteasome inhibitors and immunomodulators 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 (soft tissue mass) or serum M protein ≥10g/L or urine M protein ≥200mg/24h;
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 BCMA 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 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 grade 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 Plasma Cell Tumors