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Lymphoma, Large B-Cell, DiffusePhase 2NCT06093841

Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL

A Phase 2 study testing Relmacabtagene Autoleucel, Fludarabine and Cyclophosphamide in people with Lymphoma, Large B-Cell, Diffuse and Follicular Lymphoma Grade 3B, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 13 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary objective of this study is to asess the efficacy of Relmacabtagene autoleucel as second-line therapy in adult patients with aggressive B-cell Non-Hodgkins Lymphoma who are ineligible for haematopoietic stem cell transplantation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Relmacabtagene Autoleucel, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
13 sitesChina
Study dates
3 Nov 2023to 4 Nov 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age≥18 years;
  • Signed written informed consent obtained prior to any study procedures;
  • Histologically confirmed relapsed or refractory (R/R) aggressive B-cell NHL of the following histologiesLBCL as defined by the World Health Organization (WHO) Classification 2022:Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), high-grade B-cell lymphoma (HGL) with MYC and BCL2 rearrangements,HGL-NOS, Primary mediastinal large B-cell lymphoma, Follicular lymphoma Grade 3B (FL3B),Indolent B-NHL-transformed large B-cell lymphoma with adequate prior treatment with anthracycline-containing agents and rituximab or other CD20-targeted agents;
  • Subjects must meet the definition of refractory or relapsed;
  • Subjects were not eligible for HDCT/ASCT based on the investigator's assessment ;
  • Adequate organ function;
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  • Presence of positive PET assessable lesions as determined by the Lugano criteria ;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • Expected survival greater than 12 weeks;
  • Adequate vascular access for leukapheresis procedure;
  • Women of childbearing potential must agree to use highly effective methods of contraception for at least 28 days prior to lymphocyte clearance chemotherapy through 2 year after Relmacabtagene Autoleucel infusion; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 2 year after Relmacabtagene Autoleucel infusion;

Who cannot join

  • Subjects with non-Hodgkin's lymphoma who have received second or more line therapy;
  • Lymphoma of the primary center (subjects with secondary central nervous system lymphoma are allowed to enroll;
  • History of another primary malignancy that has not been in remission for at least 2 years;
  • Subjects has active 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;
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  • Uncontrolled diabetes and hypertension;
  • Presence of acute or chronic graft-versus-host disease (GVHD);
  • Active autoimmune disease requiring immunosuppressive therapy;
  • History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
  • Pregnant or nursing women;
  • Subjects Received an autologous or allogeneic hematopoietic stem cell transplant;
  • 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;
  • Received live vaccination within 6 weeks prior to lymphocyte clearance chemotherapy;
  • History of severe hypersensitivity reactions to any of the drug ingredients used in this study product.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Beijing Tongren Hospital

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Sun Yat-sen University Cancer Hospital

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Jiangsu Provincial People's Hospital

    Nanjing

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,

    Shanghai, Shanghai Municipality, 200025

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Institute of Hematology&Hospital of Blood Disease CAMS

    Tianjin, Tianjin Municipality, 300000

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL: a Single-arm, Multicenter, Open, Phase II Study

The primary objective of this study is to asess the efficacy of Relmacabtagene autoleucel as second-line therapy in adult patients with aggressive B-cell Non-Hodgkins Lymphoma who are ineligible for haematopoietic stem cell transplantation.

Read the detailed description

This is an open-label, multicenter, Phase 2 study to determine the antitumor activity, PK, and safety of JWCAR029(Relmacabtagene autoleucel ) in subjects who have relapsed within 12 months from, or are refractory to, a single line of immunochemotherapy for aggressive Bcell NHL and are ineligible for HSCT (as defined in the eligibility criteria). Subjects will be treated with lymphodepleting chemotherapy and JWCAR029.

Being tested
Relmacabtagene Autoleucel, Fludarabine, Cyclophosphamide
Keywords
Relmacabtagene Autoleucel, aggressive B-cell non-Hodgkin lymphoma, Chimeric antigen receptor T cells, second-line
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • Relmacabtagene AutoleucelBiological

    Also called JWCAR029

    A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

  • FludarabineDrug

    Administered according to package insert

  • CyclophosphamideDrug

    Administered according to package insert

Study groups in NCT06093841
Study groupRoleWhat they receive
Relmacabtagene AutoleucelExperimentalExperimental: Relmacabtagene Autoleucel Participants will receive cyclophosphamide250 mg/m^2/day intravenously (IV) and fludarabine 25 mg/m^2/day IV conditioning chemotherapy for 3 days followed by Relmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day1.
Receives: Biological: Relmacabtagene Autoleucel; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

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

  1. ORR at 3 month

    Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR);

    Measured: 3 months

Secondary outcomes (12)

  1. CRR at 3 month

    Complete response rate in subjects at 3 month

    Measured: 3 months

  2. Duration of response (DOR)

    Time from first response(PR or CR) to disease progression or death from any cause.

    Measured: up to 2 years after Relmacabtagene Autoleucel infusion

  3. Duration of complete remission (DoCR)

    Time from complete response (CR) to disease progression or death from any cause.

    Measured: up to 2 years after Relmacabtagene Autoleucel infusion

  4. Duration of partial remission (DoPR)

    Time from partial response (PR) to disease progression or death from any cause.

    Measured: up to 2 years after Relmacabtagene Autoleucel infusion

  5. Time to response (TTR)

    Time from JWCAR029 infusion to first documentation of CR or PR

    Measured: up to 2 years after Relmacabtagene Autoleucel infusion

  6. Progression-Free Survival (PFS)

    PFS is defined as the time from the Relmacabtagene Autoleucel infusion date to the date of disease progression per Lugano classification or death from any cause.

    Measured: up to 2 years after Relmacabtagene Autoleucel infusion

  7. Overall Survival (OS)

    OS is defined as the time from Relmacabtagene Autoleucel infusion to the date of death from any cause.

    Measured: up to 2 year after Relmacabtagene Autoleucel infusion

  8. Adverse events (AEs)

    Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter

    Measured: up to 2 year after Relmacabtagene Autoleucel infusion

  9. Pharmacokinetic (PK)- Cmax of Relmacabtagene Autoleucel

    Maximum observed concentration of Relmacabtagene Autoleucel in peripheral blood

    Measured: up to 1 year after Relmacabtagene Autoleucel infusion

  10. Pharmacokinetic (PK)- Tmax of Relmacabtagene Autoleucel

    Time to maximum concentration of Relmacabtagene Autoleucel in peripheral blood

    Measured: up to 1 year after Relmacabtagene Autoleucel infusion

  11. Pharmacokinetic (PK)- AUC of Relmacabtagene Autoleucel

    Area under the concentration vs time curve of Relmacabtagene Autoleucel

    Measured: up to 1 year after Relmacabtagene Autoleucel infusion

  12. The concentration of Car-T cell

    The concentration of Car-T cell in peripheral blood

    Measured: up to 1 year after Relmacabtagene Autoleucel infusion

Timeline

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

  1. First posted23 Oct 2023
  2. Study start3 Nov 2023
  3. Primary completion21 Jan 2024
  4. Study completion4 Nov 2029 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06093841
Sponsor's protocol ID
JWCAR029216
Status last verified
Feb 2025
First submitted
16 Oct 2023
Last updated
11 Feb 2025
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 2 study testing Relmacabtagene Autoleucel, Fludarabine and Cyclophosphamide in people with Lymphoma, Large B-Cell, Diffuse and Follicular Lymphoma Grade 3B, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 13 sites 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 16 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: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

ORR at 3 month (time frame: 3 months). 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 NCT06093841.

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 11 Feb 2025.

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