Phase I Study of JWCAR029 in Subjects With R/R CLL/SLL

NCT05259813 | Withdrawn Phase 1

• 1 other identifier: JWCAR029-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, open-label, single-arm, single center study to assess the safety and efficacy of JWCAR029 in subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Outcome Measures

Primary Outcomes (2)

• Treatment-related adverse events (AEs)

  Type, Proportion, and Severity

  2 years

• Recommended dose of JWCAR029

  Recommended dose of JWCAR029

  28 days after JWCAR029 infusion

Secondary Outcomes (12)

• Best Objective response (BOR) rate

  3 months

• Best Complete response (CR) rate

  3 months

• Objective response rate (ORR)

  3 months

• Complete response rate (CRR)

  3 months

• MRD-negative response rate

  3 months

Study Arms (1)

JWCAR029 Treatment

EXPERIMENTAL

Dose-finding for JWCAR029 monotherapy

Genetic: JWCAR029 (Relmacabtagene Autoleucel)

Interventions

JWCAR029 (Relmacabtagene Autoleucel) GENETIC

CD19-targeted Chimeric Antigen Receptor (CAR) T Cells

JWCAR029 Treatment

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years old and ≤ 75 years old;
• Sign on the informed consent;
• Diagnosis of:
• CLL with an indication for treatment based on iwCLL 2018 and measurable disease, or
• SLL (lymphadenopathy and/or splenomegaly and \< 5×10\^9 CD19+ CD5+ clonal B lymphocytes/L \[\< 5000/µL\] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL);
• Relapsed/refractory patients, Subjects must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Expected survival is greater than 12 weeks;
• Adequate organ function;
• Adequate vascular access for leukapheresis procedure;
• Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029.

You may not qualify if:

• Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma;
• History of another primary malignancy that has not been in remission for at least 2 years;
• Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
• Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
• Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
• Presence of acute or chronic graft-versus-host disease (GVHD);
• History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
• Pregnant or nursing women;
• Subjects using of any chemotherapy, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
• Received allo-hematopoietic stem cell transplantation therapy previously.
• Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
• Received CAR T-cell or other genetically-modified T-cell therapy previously.

Sponsors & Collaborators

• Shanghai Ming Ju Biotechnology Co., Ltd.: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

relmacabtagene autoleucel

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• JianYong Li

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 2, 2022
• Study Start: February 28, 2022
• Primary Completion: January 31, 2023
• Study Completion: March 31, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)