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

Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial

Official title:

An Open Label, Single-arm, Phase I Study of JWCAR029 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05259813
• Other study ID #: JWCAR029-007
• Status: Withdrawn
• Phase: Phase 1
• Start date: February 28, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: Shanghai Ming Ju Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Upon the successful product generation of Relmacabtagene Autoleucel, subjects will enter the treatment phase of the study. Treatment will include lymphodepleting chemotherapy followed by Relmacabtagene Autoleucel administration. Subjects will then enter the post-treatment follow-up phase of the study and will be followed for approximately 24 months for safety, disease status, and survival. Long-term follow-up will continue under a separate long-term follow-up protocol, currently up to 15 years after the last Relmacabtagene Autoleucel administration.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2025
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• = 18 years old and = 75 years old;

• Sign on the informed consent;

• Diagnosis of:

1. CLL with an indication for treatment based on iwCLL 2018 and measurable disease, or

2. 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Genetic:
• JWCAR029 (Relmacabtagene Autoleucel)
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Ming Ju Biotechnology Co., Ltd.	The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related adverse events (AEs)	Type, Proportion, and Severity	2 years
Primary	Recommended dose of JWCAR029	Recommended dose of JWCAR029	28 days after JWCAR029 infusion
Secondary	Best Objective response (BOR) rate	iwCLL2018	3 months
Secondary	Best Complete response (CR) rate	iwCLL2018	3 months
Secondary	Objective response rate (ORR)	iwCLL2018	3 months
Secondary	Complete response rate (CRR)	iwCLL2018	3 months
Secondary	MRD-negative response rate	Proportion of subjects who achieve MRD-negative OR and CR	3 months
Secondary	Progression free survival (PFS)	iwCLL2018	2 years
Secondary	Overall survival (OS)	iwCLL2018	2 years
Secondary	Duration of response	iwCLL2018	2 years
Secondary	Pharmacokinetics- Maximum concentration (Cmax)	Flow cytometry and qPCR	2 years
Secondary	Pharmacokinetics- Time of the maximum concentration (Tmax)	Flow cytometry and qPCR	2 years
Secondary	Pharmacokinetics- area under the curve	Flow cytometry and qPCR	2 years
Secondary	Serum cytokines associated with CRS	IL-6, IL-8, TGF-ß1, TNF-a, etc.	2 years