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Active, not recruitingNCT04718883Updated Nov 24, 2023

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

A Phase 2 interventional study of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells in Mantle Cell Lymphoma, sponsored by Shanghai Ming Ju Biotechnology Co., Ltd.. Active, not recruiting at 12 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Shanghai Ming Ju Biotechnology Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
59
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Mantle Cell Lymphoma

Keywords

  • JWCAR029
  • B-Cell Malignancies
  • Non-Hodgkin lymphoma
  • CAR T cells
  • Chimeric antigen receptor
  • Relapsed/Refractory
  • Mantle Cell Lymphoma
03

In context

Lymphoma, Mantle-Cell

810 studies on the registry are indexed under Lymphoma, Mantle-Cell; 149 are open to participants now.

This study's enrollment of 59 is above the median of 39 across 718 interventional studies indexed under Lymphoma, Mantle-Cell.

Browse Lymphoma, Mantle-Cell studies →

Lead sponsor

Shanghai Ming Ju Biotechnology Co., Ltd. is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥ 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;
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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);
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    JWCAR029 treatment

    JWCAR029 be administrated at dose level: 1 x 10\^8 CAR+T cells

    Biological: CD19-targeted Chimeric Antigen Receptor (CAR) T Cells

Interventions

  • BiologicalCD19-targeted Chimeric Antigen Receptor (CAR) T Cells

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

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR)

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

    Time frame: 3 months

Secondary outcomes

  1. Complete response rate (CRR)

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

    Time frame: 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

    Time frame: 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

    Time frame: 3 months

  4. Number of participants with adverse events (AEs)

    Number of participants with adverse events

    Time frame: Up to 24 months after JWCAR029 infusion

  5. Type of adverse events (AEs)

    Type of adverse events

    Time frame: Up to 24 months after JWCAR029 infusion

  6. Severity of adverse events(AEs)

    Severity of adverse events

    Time frame: Up to 24 months after JWCAR029 infusion

  7. Number of participants with laboratory abnormalities

    Number of participants with laboratory abnormalities

    Time frame: Up to 24 months after JWCAR029 infusion

  8. Type of laboratory abnormalities

    Type of laboratory abnormalities

    Time frame: Up to 24 months after JWCAR029 infusion

  9. Severity of laboratory abnormalities

    Severity of laboratory abnormalities

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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)

    Time frame: Up to 24 months after JWCAR029 infusion

  14. Time to complete response (TTCR)

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

    Time frame: Up to 24 months after JWCAR029 infusion

  15. Cmax of JWCAR029

    Maximum observed concentration of JWCAR029 in peripheral blood

    Time frame: Up to 1 year after JWCAR029 infusion

  16. Tmax of JWCAR029:

    Time to maximum concentration of JWCAR029 in the peripheral blood

    Time frame: Up to 1 year after JWCAR029 infusion

  17. AUC of JWCAR029:

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

    Time frame: Up to 1 year after JWCAR029 infusion

  18. Progression-free survival (PFS)

    Progression-free survival

    Time frame: Up to 2 year after JWCAR029 infusion

  19. Overall survival (OS)

    Overall survival

    Time frame: Up to 5 year after JWCAR029 infusion

  20. Anti-therapeutic JWCAR029 antibody

    Anti-therapeutic JWCAR029 antibody

    Time frame: Up to 2 year after JWCAR029 infusion

  21. Changes of T cell counts

    Changes of T cell counts

    Time frame: Up to 2 year after JWCAR029 infusion

  22. Changes of Subgroups of T cell

    Changes of Subgroups of T cell

    Time frame: Up to 2 year after JWCAR029 infusion

  23. Changes of serum cytokines

    Changes of serum cytokines

    Time frame: Up to 2 year after JWCAR029 infusion

  24. CD19 expression in tumor biopsy samples

    CD19 expression in tumor biopsy samples

    Time frame: Up to 2 year after JWCAR029 infusion

  25. Changes in inflammatory biomarkers such as CRP

    Changes in inflammatory biomarkers such as CRP

    Time frame: Up to 2 year after JWCAR029 infusion

  26. Changes in inflammatory biomarkers such as ferritin

    Changes in inflammatory biomarkers such as CRP

    Time frame: Up to 2 year after JWCAR029 infusion

07

Study locations

12 sites
  • Peking University Cancer Hospital
    Beijing, Beijing Municipality 100000, China
  • Peking University Third Hospital
    Beijing, Beijing Municipality, China
  • Fujian Medical University Consonancy Hospital
    Fuzhou, Fujiang, China
  • Guangdong Province people hospital
    Guanzhou, Guangdong, China
  • Henan Province Cancer Hospital
    Zhengzhou, Henan, China
  • Jiangsu Province People Hospital
    Nanjing, Jiangsu, China
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
  • Zhongshan Hospital affiliated to Fudan University
    Shanghai, Shanghai Municipality, China
  • Institute of Hematology, Chinese Academy of Medical Sciences
    Tianjin, Tianjin Municipality, China
  • Tianjin Cancer Hospital
    Tianjin, Tianjin Municipality, China
  • The First Affiliated Hospital of Zhejiang University
    Hangzhou, Zhejiang, China
  • Zhejiang province Cancer Hospital
    Hangzhou, Zhejiang, China
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04718883
Lead sponsor
Shanghai Ming Ju Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
Jan 22, 2021
Start date
Jan 13, 2021
Primary completion
Oct 25, 2023
Completion
Aug 7, 2028 (estimated)
Last update
Nov 24, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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