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Leukemia, Lymphocytic, Chronic, B-CellPhase 1NCT05259813

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

A Phase 1 study testing JWCAR029 (Relmacabtagene Autoleucel) in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Leukemia, Lymphocytic, Chronic, B-Cell
What is being tested?
JWCAR029 (Relmacabtagene Autoleucel)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
28 Feb 2022to 31 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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;
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  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

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

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

Read the 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.

Being tested
JWCAR029 (Relmacabtagene Autoleucel)
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JWCAR029 (Relmacabtagene Autoleucel)Genetic

    CD19-targeted Chimeric Antigen Receptor (CAR) T Cells

Study groups in NCT05259813
Study groupRoleWhat they receive
JWCAR029 TreatmentExperimentalDose-finding for JWCAR029 monotherapy
Receives: Genetic: JWCAR029 (Relmacabtagene Autoleucel)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-related adverse events (AEs)

    Type, Proportion, and Severity

    Measured: 2 years

  2. Recommended dose of JWCAR029

    Recommended dose of JWCAR029

    Measured: 28 days after JWCAR029 infusion

Secondary outcomes (12)

  1. Best Objective response (BOR) rate

    iwCLL2018

    Measured: 3 months

  2. Best Complete response (CR) rate

    iwCLL2018

    Measured: 3 months

  3. Objective response rate (ORR)

    iwCLL2018

    Measured: 3 months

  4. Complete response rate (CRR)

    iwCLL2018

    Measured: 3 months

  5. MRD-negative response rate

    Proportion of subjects who achieve MRD-negative OR and CR

    Measured: 3 months

  6. Progression free survival (PFS)

    iwCLL2018

    Measured: 2 years

  7. Overall survival (OS)

    iwCLL2018

    Measured: 2 years

  8. Duration of response

    iwCLL2018

    Measured: 2 years

  9. Pharmacokinetics- Maximum concentration (Cmax)

    Flow cytometry and qPCR

    Measured: 2 years

  10. Pharmacokinetics- Time of the maximum concentration (Tmax)

    Flow cytometry and qPCR

    Measured: 2 years

  11. Pharmacokinetics- area under the curve

    Flow cytometry and qPCR

    Measured: 2 years

  12. Serum cytokines associated with CRS

    IL-6, IL-8, TGF-β1, TNF-α, etc.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start28 Feb 2022 (estimated)
  3. Primary completion31 Jan 2023 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Why it stopped: Due to the COVID-19 pandemic，no subjects enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05259813
Sponsor's protocol ID
JWCAR029-007
Status last verified
Nov 2023
First submitted
8 Feb 2022
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JWCAR029 (Relmacabtagene Autoleucel) in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-related adverse events (AEs) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05259813.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.

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