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Lymphoma, Non-HodgkinPhase 2NCT06149169

CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma

A Phase 2 study testing CD19-targeted Chimeric Antigen Receptor(CAR) T Cells in people with Lymphoma, Non-Hodgkin and Diffuse Large B Cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CD19-targeted Chimeric Antigen Receptor(CAR) T Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
17 Aug 2023to 31 Mar 2025
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;
  • Subjects must have histologically confirmed Large B-cell Lymphoma;
  • Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy include autologous hematopoietic stem cell transplantation(auto-HSCT);
  • Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
  • Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
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  • Adequate organ function;
  • Adequate vascular access for leukapheresis procedur;
  • Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still expresss CD19;
  • Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
  • Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.

Who cannot join

  • Central nervous system(CNS) only involvement by malignancy or primary CNS lymphoma;
  • History of another primary malignancyn that has not been in remission for at least 2 years;
  • Subjects has HBV,HCV,HIV or syphilis nefection at the time of screening;
  • Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active 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 woman;
  • Subjects using of any chemotherapy,corticisteriod,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
  • 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

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed and Refractory (R/R) LBCL

This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.

Read the detailed description

This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate the pharmacokinetics(PK), safety and efficacy of relma-cel, monitor the immune response after relma-cel treatment.

Relma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10^8 CAR+T cells.The indication for this application is R/R LBCL(supplement study) and the recommended dose is 1×10^8 CAR+T cells.

Being tested
CD19-targeted Chimeric Antigen Receptor(CAR) T Cells
Keywords
JWCAR029, B-Cell Malignancies, CAR T cells, Chimeric antigen receptor, Relapsed/Refractory
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Recurrence

What participants receive

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

  • CD19-targeted Chimeric Antigen Receptor(CAR) T CellsBiological

    Relma-cel be administered at one dose level:1×10^8 CAR+T cells

Study groups in NCT06149169
Study groupRoleWhat they receive
Relma-celExperimentalThe PK, safety and efficacy of Relma-cel will be evaluated in 1 x 10^8 CAR+T cells dose level
Receives: Biological: CD19-targeted Chimeric Antigen Receptor(CAR) T Cells

What is being measured

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

  1. Pharmacokinetic(PK)-Cmax of Relma-cel

    Maximum observed concentration of Relma-cel in peripheral blood

    Measured: up to 1 year after Relma-cel infusion

  2. Pharmacokinetic(PK)-Tmax of Relma-cel

    Time to maximum concentration of Relma-cel in peripheral blood

    Measured: up to 1 year after Relma-cel infusion

  3. Pharmacokinetic(PK)-AUC of Relma-cel

    Area under the concentration vs time curve of Relma-cel

    Measured: up to 1 year after Relma-cel infusion

Secondary outcomes (10)

  1. Objective response rate (ORR) in LBCL subjects

    Objective response rate (ORR) in 3 month evaluated by investigator of LBCL subjects.

    Measured: 3 months

  2. Best objective response rate ( Best ORR) in LBCL subjects

    Best objective response rate (ORR) evaluated by the investigator of LBCL subjects.

    Measured: up to 1 year after Relma-cel infusion

  3. Complete response rate (CRR) in LBCL subjects

    Complete response rate (CRR) at any time points evaluated by the investigator.

    Measured: up to 1 year after Relma-cel infusion

  4. Adverse events (AEs)

    These adverse events would be measured by assessment scale method according to NCI-CTCAE v4.03 classification standard.

    Measured: up to 1 year after Relma-cel infusion

  5. Duration of response (DOR)

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

    Measured: up to 1 year after Relma-cel infusion

  6. Progression-free survival (PFS)

    Progression-free survival

    Measured: up to 1 year after Relma-cel infusion

  7. Overall survival (OS)

    Overall survival

    Measured: up to 1 year after Relma-cel infusion

  8. Changes of serum cytokines-IL-2，IL-6，IL-8 and IFN- γ

    The changes of serum cytokines-IL-2，IL-6，IL-8 and IFN- γ after Relma-cel infusion.

    Measured: up to 1 year after Relma-cel infusion

  9. Changes of inflammation biomarker-CRP

    The changes of inflammation biomarker-CRP after Relma-cel infusion.

    Measured: up to 1 year after Relma-cel infusion

  10. Changes of inflammation biomarker-serum ferritin

    The changes of inflammation biomarker-serum ferritin after Relma-cel infusion.

    Measured: up to 1 year after Relma-cel infusion

Timeline

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

  1. First posted28 Nov 2023
  2. Study start17 Aug 2023
  3. Primary completion30 Oct 2024 (estimated)
  4. Study completion31 Mar 2025 (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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06149169
Sponsor's protocol ID
JWCAR029-017
Status last verified
Mar 2024
First submitted
14 Nov 2023
Last updated
21 Aug 2024
Results posted
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 CD19-targeted Chimeric Antigen Receptor(CAR) T Cells in people with Lymphoma, Non-Hodgkin and Diffuse Large B Cell Lymphoma, 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 11 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 21 Aug 2024. 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 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?

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?

Pharmacokinetic(PK)-Cmax of Relma-cel (time frame: up to 1 year after Relma-cel infusion). The study lists 3 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 NCT06149169.

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 21 Aug 2024; AzTrials last refreshed its copy on 2 Nov 2026.

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