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

NCT04665076 | Unknown

• 1 other identifier: 2020104
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-center, non-randomized, single-arm, open clinical trial.

Conditions

Plasma Cell Tumors

Outcome Measures

Primary Outcomes (2)

• Safety: Incidence and severity of adverse events

  To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

  first one month after CAR-T infusion

• Efficacy: Remission Rate

  Remission Rate including complete remission (CR), partial remission (PR), objective response (ORR = CR + PR), disease stability (SD), disease progression (PD) and unresponsive (NR)

  3 months post CAR-T cells infusion

Secondary Outcomes (2)

• Efficacy:duration of response (DOR)

  24 months after CAR-T infusion

• Efficacy: progression-free survival (PFS)

  24 months after CAR-T infusion

Study Arms (1)

Auto CAR-T

EXPERIMENTAL

Patients will be treated with Auto CAR-T cells

Biological: Auto CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis

Interventions

Auto CAR-T BIOLOGICAL

Biological: Auto CAR-T

Auto CAR-T

Cyclophosphamide,Fludarabine DRUG

Drug: Cyclophosphamide,Fludarabine

Auto CAR-T

Leukapheresis PROCEDURE

Leukapheresis

Auto CAR-T

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Patients with relapsed/refractory plasma cell tumors determined by clinical diagnosis;
• The definition of relapsed/refractory plasma cell tumors is:
• Primary resistance to standard treatment regimens;
• Or PD occurs after standard treatment with at least second-line standard treatment plan;
• Or the last treatment effect is SD and the duration does not exceed 6 months;
• Or treatment with proteasome inhibitors and immunomodulators is ineffective or relapses;
• 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.
• 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;
• Subjects whose physical status scored by the Eastern Cooperative Oncology Group (ECOG) is 0\~2;
• years old ≤ age ≤ 75 years old, both male and female;
• Immunohistochemistry or flow cytometry detects tumor cells as BCMA or CD19/CD22/CD79 positive;
• The estimated survival period from the date of signing the informed consent form is greater than 3 months;
• 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;
• 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).

You may not qualify if:

• Severe cardiac insufficiency, left ventricular ejection fraction \<50%;
• There is a history of severe lung dysfunction diseases;
• 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;
• 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
• Combined metabolic diseases (except diabetes);
• Combined with severe autoimmune disease or innate immune deficiency;
• 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;
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
• A history of severe allergies to biological products (including antibiotics);
• Participate in any other clinical drug trials at the same time within one month;
• 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.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead
• Hebei Medical University Fourth Hospital: collaborator

Study Sites (1)

Hematology Department, Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Plasmacytoma

Interventions

CF regimen; Leukapheresis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Baoen Shan, PhD & MD

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

• Lihong Liu, PhD & MD

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianqiang Li, PhD & MD

CONTACT

008615511369555; limmune@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 11, 2020
• Study Start: October 22, 2020
• Primary Completion: October 21, 2023
• Study Completion: October 21, 2025
• Last Updated: December 11, 2020

Record last verified: 2020-10

Locations

CN (1)