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B-cell LymphomaPhase 2NCT05590221

Relmacabtagene Autoleucel as First-Line Therapy for High-Risk Large B-Cell Lymphoma

A Phase 2 study testing Relmacabtagene Autoleucel, Fludarabine and Cyclophosphamide in people with B-cell Lymphoma, run by Peking University Cancer Hospital & Institute at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this study is to estimate the efficacy of Relmacabtagene Autoleucel in participants with high-risk large B-cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Lymphoma
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
20 participants
Where
4 sitesChina
Study dates
3 Jan 2023to 10 Dec 2024
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years old;
  • Sign on the informed consent;
  • Histologically confirmed large B-cell lymphoma that also meets the definition of high-risk large B-cell lymphoma as a lymphoma International Prognostic Index (IPI) score of 3-5 and/or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement (double/triple-hit lymphoma) (DHL/THL) and must be treated with 2 cycles of CD20 monoclonal antibodies combined with anthracyclines. Presence of positive PET assessable lesions (DS score of 4 or 5) as determined by the Lugano criteria (Cheson et al., 2014)；
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Expected survival greater than 12 weeks；
  • Adequate organ function：
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  • Absolute neutrophil count ≥ 1000/μL；Absolute lymphocyte count ≥ 100/μL； Platelet count ≥ 75,000/μL；Hb ≥ 80g/L；
  • Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (Cockcroft-Gault formula) > 50 mL/min (serum creatinine clearance due to lymphoma mass compression should be > 30 mL/min)；
  • Serum alanine aminotransferase (ALT) ≤ 5 upper limit of normal (ULN) and total bilirubin ≤2ULN（or for subjects with Gilbert's syndrome or lymphoma invading the liver < 3 ULN）；
  • Baseline oxygen saturation > 92% on room air；
  • Left ventricular ejection fraction (LVEF) ≥50% assessed by echocardiography or radionuclide activity angiography (MUGA) within 1 month of enrollment；
  • 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 1 year after Relmacabtagene Autoleucel infusion; Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after Relmacabtagene Autoleucel infusion.

Who cannot join

  • Lymphoma involving the central nervous system (CNS)；
  • History of another primary malignancy that has not been in remission for at least 2 years;
  • History of Richter's transformation of chronic lymphocytic leukemia or primary mediastinal B-cell lymphoma；
  • 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;
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  • 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 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

4 sites in 1 country.

Yuqin Song, PhD contact

+86 010-88121122

songyuqin622@163.com

Medical JWCAR029 contact

+86 21 50464201

JWCAR029Medical@jwtherapeutics.com

China4 sites, 4 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100010

    Yuqin Song, PhD

    Recruiting

  • Peking University International Hospital

    Beijing, Beijing Municipality, 100010

    Liu xinjian

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Huilai Zhang, zhanghltch@163.com

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Keshu Zhou, drzhouks77@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: Study to Evaluate the Efficacy and Safety of Relmacabtagene Autoleucel (Relma-cel) as First-Line Therapy in Adult Participants With High-Risk Large B-Cell Lymphoma

The primary objective of this study is to estimate the efficacy of Relmacabtagene Autoleucel in participants with high-risk large B-cell lymphoma.

Read the detailed description

This is a prospective, open-label, multicenter, single-arm trial, assessed the efficacy and safety of JWCAR029(relma-cel) as part of first-line therapy after an incomplete first-line treatment regimen of two cycles of chemoimmunotherapy. High-risk LBCL was defined by the dynamic risk assessment of interim PET2+, together with either double- or triple-hit lymphomas or high-intermediate- and high-risk IPI scores (≥3). All sujects will be followed for 2 years following JWCAR029 infusion.

Conditions
B-cell Lymphoma
Being tested
Relmacabtagene Autoleucel, Fludarabine, Cyclophosphamide
Medical subject headings
Lymphoma, B-Cell

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 NCT05590221
Study groupRoleWhat they receive
Relmacabtagene AutoleucelExperimentalParticipants 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 Day 1.
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. Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators

    Complete Response Rate (CRR): percentage of participants with CR [complete metabolic response (CMR); complete radiological response (CRR)]. CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake ≤ mediastinum), 3 (uptake > mediastinum but ≤ liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter of lesion (LDi); no extralymphatic sites of disease; absent non-measured lesion (NMLs); organ enlargement regress to normal; no new sites; and bone marrow normal by morphology.

    Measured: up to 2 years after Relmacabtagene Autoleucel infusion

Secondary outcomes (11)

  1. Objective Response Rate (ORR) Per the Lugano Classification as Determined by Study Investigators

    ORR: percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR); partial radiologic response (PRR)].CMR: PET 5PS scores of 1 (no uptake above background, 2 (uptake ≤ mediastinum), 3 (uptake > mediastinum but ≤ liver) with/without a residual mass; no new lesions; no evidence of FDG-avid disease in BM. CRR:target nodes/nodal masses regressed to ≤ 1.5 cm in LDi;no extralymphatic sites of disease;absent NMLs;organ enlargement regress to normal;no new sites;bone marrow morphology normal. PMR:scores 4 (uptake moderately > liver),5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment (EOT).PRR: ≥ 50% decrease in sum of the product of perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs;spleen regressed by > 50% in length beyond normal;no new sites.

    Measured: up to 2 years after Relmacabtagene Autoleucel infusion

  2. Duration of Response (DOR) Per the Lugano Classification

    DOR is defined only for participants who experience an objective response after Relmacabtagene Autoleucel infusion and is the time from the first objective response to disease progression or death from any cause. Objective response is defined in outcome measure (OM) 2.

    Measured: up to 2 years after Relmacabtagene Autoleucel infusion

  3. Event-Free Survival (EFS)

    First infusion date of Relmacabtagene Autoleucel to data cut off

    Measured: up to 2 years after Relmacabtagene Autoleucel infusion

  4. 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

  5. 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 years after Relmacabtagene Autoleucel infusion

  6. Types, frequency, and severity of adverse events and laboratory anomalies

    Physiological parameter

    Measured: up to 2 years after Relmacabtagene Autoleucel infusion

  7. Pharmacokinetic (PK)- Cmax of Relmacabtagene Autoleucel

    Maximum observed concentration of Relmacabtagene Autoleucel in peripheral blood

    Measured: up to 1 year after Relmacabtagene Autoleucel infusion

  8. 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

  9. 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

  10. The concentration of Car-T cell

    The concentration of Car-T cell in peripheral blood

    Measured: up to 1 year after Relmacabtagene Autoleucel infusion

  11. The change of serum cytokines concentration

    The change of serum cytokines(IL-2、IL-4、IL-6、IL-8、IL-10、IL-17A、IFN-γ、TNF-α、IFN-α) concentration after Relmacabtagene Autoleucel infusion

    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 posted21 Oct 2022
  2. Study start3 Jan 2023
  3. Primary completion10 Feb 2024 (estimated)
  4. Study completion10 Dec 2024 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05590221
Sponsor's protocol ID
JWCAR029011
Status last verified
Nov 2023
First submitted
12 Oct 2022
Last updated
8 Jan 2024
Results posted
No
Data monitoring committee
Yes
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 B-cell Lymphoma, run by Peking University Cancer Hospital & Institute at 4 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 13 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Results are not available in the source record.

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

Contact Yuqin Song, PhD (+86 010-88121122, songyuqin622@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators (time frame: up to 2 years after Relmacabtagene Autoleucel infusion). 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 NCT05590221.

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 8 Jan 2024.

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