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Mantle Cell LymphomaPhase 2NCT04718883

CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma

A Phase 2 study testing CD19-targeted Chimeric Antigen Receptor (CAR) T Cells in people with Mantle Cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 12 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

This is a phase II, open-label, single-arm, multicenter study to assess the efficacy and safety of JWCAR029 in adult R/R Mantle Cell Lymphoma subjects in China. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
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
59 participants
Where
12 sitesChina
Study dates
13 Jan 2021to 7 Aug 2028
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

  • ≥ 18 years old;
  • Sign on the informed consent;
  • Subject must have histologically confirmed mantle cell lymphoma;
  • Relapsed/refractory patients;
  • 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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  • Expected survival is greater than 12 weeks;
  • Adequate organ function;
  • Adequate vascular access for leukapheresis procedure;
  • Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
  • 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

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100000

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • Fujian Medical University Consonancy Hospital

    Fuzhou, Fujiang

  • Guangdong Province people hospital

    Guanzhou, Guangdong

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang

  • Zhejiang province Cancer Hospital

    Hangzhou, Zhejiang

  • Jiangsu Province People Hospital

    Nanjing, Jiangsu

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Zhongshan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Institute of Hematology, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

  • Henan Province Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase II Open-Label, Single-Arm, Multicenter Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma

This is a phase II, open-label, single-arm, multicenter study to assess the efficacy and safety of JWCAR029 in adult R/R Mantle Cell Lymphoma subjects in China.

Read the detailed description

This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with relapsed and refractory (R/R) mantle cell lymphoma (MCL) in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and immune response after JWCAR029 treatment.

R/R MCL patients will be enrolled in dose level of 1.0 x 10^8 CAR+ T cells. All subjects will be followed for 5 years following JWCAR029 infusion.

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

    JWCAR029 will be administered at dose level: 1 x 10^8 CAR+T cells

Study groups in NCT04718883
Study groupRoleWhat they receive
JWCAR029 treatmentExperimentalJWCAR029 be administrated at dose level: 1 x 10^8 CAR+T cells
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. Objective response rate (ORR)

    Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

    Measured: 3 months

Secondary outcomes (26)

  1. Complete response rate (CRR)

    Complete response rate (CRR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

    Measured: 3 months

  2. The best objective response rate

    The best objective response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

    Measured: 3 months

  3. The best complete response rate

    The best complete response rate in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects

    Measured: 3 months

  4. Number of participants with adverse events (AEs)

    Number of participants with adverse events

    Measured: Up to 24 months after JWCAR029 infusion

  5. Type of adverse events (AEs)

    Type of adverse events

    Measured: Up to 24 months after JWCAR029 infusion

  6. Severity of adverse events(AEs)

    Severity of adverse events

    Measured: Up to 24 months after JWCAR029 infusion

  7. Number of participants with laboratory abnormalities

    Number of participants with laboratory abnormalities

    Measured: Up to 24 months after JWCAR029 infusion

  8. Type of laboratory abnormalities

    Type of laboratory abnormalities

    Measured: Up to 24 months after JWCAR029 infusion

  9. Severity of laboratory abnormalities

    Severity of laboratory abnormalities

    Measured: Up to 24 months after JWCAR029 infusion

  10. Duration of response (DOR)

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

    Measured: Up to 24 months after JWCAR029 infusion

  11. Duration of complete remission (DoCR)

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

    Measured: Up to 24 months after JWCAR029 infusion

  12. Duration of partial remission (DoPR)

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

    Measured: Up to 24 months after JWCAR029 infusion

  13. Time to response (TTR)

    Time from JWCAR029 infusion to first documentation of complete response (CR) or partial response (PR)

    Measured: Up to 24 months after JWCAR029 infusion

  14. Time to complete response (TTCR)

    Time from JWCAR029 infusion to first documentation of complete response (CR)

    Measured: Up to 24 months after JWCAR029 infusion

  15. Cmax of JWCAR029

    Maximum observed concentration of JWCAR029 in peripheral blood

    Measured: Up to 1 year after JWCAR029 infusion

  16. Tmax of JWCAR029:

    Time to maximum concentration of JWCAR029 in the peripheral blood

    Measured: Up to 1 year after JWCAR029 infusion

  17. AUC of JWCAR029:

    Area under the concentration vs time curve of JWCAR029 in the peripheral blood

    Measured: Up to 1 year after JWCAR029 infusion

  18. Progression-free survival (PFS)

    Progression-free survival

    Measured: Up to 2 year after JWCAR029 infusion

  19. Overall survival (OS)

    Overall survival

    Measured: Up to 5 year after JWCAR029 infusion

  20. Anti-therapeutic JWCAR029 antibody

    Anti-therapeutic JWCAR029 antibody

    Measured: Up to 2 year after JWCAR029 infusion

  21. Changes of T cell counts

    Changes of T cell counts

    Measured: Up to 2 year after JWCAR029 infusion

  22. Changes of Subgroups of T cell

    Changes of Subgroups of T cell

    Measured: Up to 2 year after JWCAR029 infusion

  23. Changes of serum cytokines

    Changes of serum cytokines

    Measured: Up to 2 year after JWCAR029 infusion

  24. CD19 expression in tumor biopsy samples

    CD19 expression in tumor biopsy samples

    Measured: Up to 2 year after JWCAR029 infusion

  25. Changes in inflammatory biomarkers such as CRP

    Changes in inflammatory biomarkers such as CRP

    Measured: Up to 2 year after JWCAR029 infusion

  26. Changes in inflammatory biomarkers such as ferritin

    Changes in inflammatory biomarkers such as CRP

    Measured: Up to 2 year after JWCAR029 infusion

Timeline

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

  1. First posted22 Jan 2021
  2. Study start13 Jan 2021
  3. Primary completion25 Oct 2023
  4. Study completion7 Aug 2028 (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
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04718883
Sponsor's protocol ID
JWCAR029-005
Status last verified
Nov 2023
First submitted
14 Jan 2021
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xie Y, Zhou KS, Li LF, Liang AB, Mei H, Zou DH, Li WY, Jin J, Jin ZM, Jing HM, Yang HY, Chen T, Huang HQ, He PC, Cao JN, Xia Z, Gu YE, Zang YB, Zhou ZS, Tian ZZ, Zhu J, Song YQ. Phase 2 study of relmacabtagene autoleucel (CD19 CAR-T) for relapsed/refractory mantle cell lymphoma in Chinese adults. Blood Adv. 2026 Feb 24;10(4):1134-1144. doi: 10.1182/bloodadvances.2024015763.

    PubMed 40811825

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 Mantle Cell Lymphoma, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 12 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 12 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: under way, not looking for participants, 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 12 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?

Objective response rate (ORR) (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 NCT04718883, which also lists 1 linked publication.

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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