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

Phase 1

Withdrawn

• Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
• Interventions: Genetic: JWCAR029 (Relmacabtagene Autoleucel)

• Registration Number: NCT05259813
• Lead Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-17
• Study Start: 2022-02-28
• Study First Posted: 2022-03-02
• Primary Completion: 2023-01-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JWCAR029 Treatment	JWCAR029 (Relmacabtagene Autoleucel)	Dose-finding for JWCAR029 monotherapy

Primary Outcome Measures

Name	Time	Method
Recommended dose of JWCAR029	28 days after JWCAR029 infusion	Recommended dose of JWCAR029
Treatment-related adverse events (AEs)	2 years	Type, Proportion, and Severity

Secondary Outcome Measures

Name	Time	Method
Best Complete response (CR) rate	3 months	iwCLL2018
Objective response rate (ORR)	3 months	iwCLL2018
Best Objective response (BOR) rate	3 months	iwCLL2018
Pharmacokinetics- Time of the maximum concentration (Tmax)	2 years	Flow cytometry and qPCR
Complete response rate (CRR)	3 months	iwCLL2018
MRD-negative response rate	3 months	Proportion of subjects who achieve MRD-negative OR and CR
Pharmacokinetics- area under the curve	2 years	Flow cytometry and qPCR
Pharmacokinetics- Maximum concentration (Cmax)	2 years	Flow cytometry and qPCR
Progression free survival (PFS)	2 years	iwCLL2018
Overall survival (OS)	2 years	iwCLL2018
Duration of response	2 years	iwCLL2018
Serum cytokines associated with CRS	2 years	IL-6, IL-8, TGF-β1, TNF-α, etc.

Trial Locations

Locations (1)

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China