Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma

NCT05155215 | Unknown Phase 1

• 1 other identifier: SD46
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase I/II, open-label, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult R/R Mantle Cell Lymphoma subjects

Conditions

Lymphoma; Lymphoma, Mantle-Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0

  Up to 28 days after IM19 CAR-T cell infusion

• Objective response rate (ORR)

  ORR, defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to Lugano(2014)

  At 3 months after IM19 CAR-T cell infusion

Secondary Outcomes (6)

• Objective response rate (ORR)

  At 28 days and 6 months after IM19 CAR-T cell infusion

• Progression-free survival (PFS)

  Up to 24 weeks after IM19 CAR-T cell infusion

• Duration of Response (DOR)

  Up to 24 weeks after IM19 CAR-T cell infusion

• Overall survival (OS)

  Up to 24 weeks after CAR-T cell infusion

• Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood)

  Up to 24 weeks after IM19 CAR-T cell infusion

Study Arms (1)

IM19 CAR-T cells

EXPERIMENTAL

Biological: IM19 CAR-T cells; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

IM19 CAR-T cells BIOLOGICAL

IM19 CAR-T cells will be administered at dose level: 100×10\^6 CAR-T cells or 200×10\^6 CAR-T cells

IM19 CAR-T cells

Cyclophosphamide DRUG

300 mg/m\^2 per day for 3 days (IV)

IM19 CAR-T cells

Fludarabine DRUG

30 mg/m\^2 per day for 3 days (IV)

IM19 CAR-T cells

Eligibility Criteria

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

You may qualify if:

• Subjects with relapsed or refractory mantle cell lymphoma, diagnosed as CD19 positive by cytology or histology；
• Subjects have measurable positive lesion according to Lugano Classification;
• ≥ 18 years old;
• Expected survival is greater than 3 months；
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• The toxicity caused by the previous treatment has stabilized or recovered to ≤1 level (except for the case where the investigator judges that it has no clinical significance);
• Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up;
• Adequate organ function;
• Adequate vascular access for leukapheresis procedure;
• Volunteer to participate in this trial and sign on the informed consent.

You may not qualify if:

• Central nervous system (CNS) involvement by lymphoma;
• Received allo-hematopoietic stem cell transplantation or organ transplantation therapy previously；
• Subjects with cardiac atrial or cardiac ventricular lymphoma involvement；
• Serous effusion with symptoms of compression;
• History of autoimmune disease (eg Crohn's disease, rheumatoid arthritis, systemic lupus) within the last 2 years;
• Presence of acute or chronic graft-versus-host disease (GVHD);
• Use prohibited drugs or treatments within a specified period of time before cell collection；
• Received anti-CD19 target therapy (unless the CD19 target test is still positive);
• Received CAR-T cell therapy;
• Received the study drug within 4 weeks before cell collection. However, if the trial treatment is invalid or the disease progresses, and at least 5 half-lives have passed before the cell collection, it is allowed to enter the group;
• Received radiotherapy within 6 weeks prior to cell collection, including large bone marrow areas such as the sternum or pelvis. Subjects who have progressed in the radiotherapy site or have PET-positive lesions in other non-irradiated sites are eligible to be included in the group;
• Received donor lymphocyte infusion (DLI) within 6 weeks before CAR-T cell infusion;
• If anti-PD1, PD-L1 and other immunotherapies have been used before CAR-T cell reinfusion, at least 5 half-lives must elapse between the last medication and before CAR-T cell reinfusion;
• History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posteriorreversible encephalopathy syndrome, or any autoimmune disease with CNS involvement;
• Received autologous transplantation within 6 weeks before the start of screening;

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead

MeSH Terms

Conditions

Lymphoma; Lymphoma, Mantle-Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Hongmei Jing, Ph.D

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wu, MD

CONTACT

+8615801390058; wufei@immunochina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 13, 2021
• Study Start: December 31, 2021
• Primary Completion: December 31, 2022
• Study Completion: February 28, 2023
• Last Updated: December 13, 2021

Record last verified: 2021-11