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

Sponsor
Shanghai Ming Ju Biotechnology Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05259813
Collaborator
The First Affiliated Hospital with Nanjing Medical University (Other)
12
Enrollment
1
Location
1
Arm
37
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Genetic: JWCAR029 (Relmacabtagene Autoleucel)
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: JWCAR029 Treatment

Dose-finding for JWCAR029 monotherapy

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

Outcome Measures

Primary Outcome Measures

  1. Treatment-related adverse events (AEs) [2 years]

    Type, Proportion, and Severity

  2. Recommended dose of JWCAR029 [28 days after JWCAR029 infusion]

    Recommended dose of JWCAR029

Secondary Outcome Measures

  1. Best Objective response (BOR) rate [3 months]

    iwCLL2018

  2. Best Complete response (CR) rate [3 months]

    iwCLL2018

  3. Objective response rate (ORR) [3 months]

    iwCLL2018

  4. Complete response rate (CRR) [3 months]

    iwCLL2018

  5. MRD-negative response rate [3 months]

    Proportion of subjects who achieve MRD-negative OR and CR

  6. Progression free survival (PFS) [2 years]

    iwCLL2018

  7. Overall survival (OS) [2 years]

    iwCLL2018

  8. Duration of response [2 years]

    iwCLL2018

  9. Pharmacokinetics- Maximum concentration (Cmax) [2 years]

    Flow cytometry and qPCR

  10. Pharmacokinetics- Time of the maximum concentration (Tmax) [2 years]

    Flow cytometry and qPCR

  11. Pharmacokinetics- area under the curve [2 years]

    Flow cytometry and qPCR

  12. Serum cytokines associated with CRS [2 years]

    IL-6, IL-8, TGF-β1, TNF-α, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jiangsu Province Hospital Nanjing Jiangsu China 210029

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: JianYong Li, The First Affiliated Hospital with Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Ming Ju Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05259813
Other Study ID Numbers:
  • JWCAR029-007
First Posted:
Mar 2, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Mar 2, 2022