CNS LymphomaPhase 2NCT06876688
Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma
A Phase 2 study testing Relma-cel Followed by Tislelizumab in people with CNS Lymphoma, run by Ruijin Hospital at 6 sites in China.
Trial summary
This study aims to evaluate the efficacy and safety of Relma-cel in the treatment of central nervous system lymphoma (CNSL), as well as its pharmacokinetic characteristics. Enrolled patients with relapsed/refractory (R/R) CNSL will receive Relma-cel infusion, followed by Tislelizumab treatment (200mg, IV, q4w, for 12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Lymphoma
- What is being tested?
- Relma-cel Followed by Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesChina
- Study dates
- 30 Nov 2023to 30 Nov 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
- Age greater than or equal to 18 years old, male or female;
- Relapsed or refractory CNS-involved large b-cell lymphoma after at least first-line therapy, with an efficacy assessment of CR or PR after salvage therapy, and current stable efficacy status;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- Have a life expectancy of ≥ 12 weeks
- Use contraception
- Have adequate bone marrow and organ function:
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- Neutrophil count (anc) ≥1.0 x 109/L;
- Hemoglobin ≥ 8.0 g/dl;
- Platelet count ≥ 50 x 109/L;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 x ULN or ≤ 5 x ULN (in the presence of hepatic invasion);
- Creatinine clearance ≥40mL/min
- Lipase ≤ 1.5 x ULN
Who cannot join
- Severe active central nervous system symptoms
- Prior chimeric antigen receptor cellular immunotherapy targeting cd19
- Known human immunodeficiency virus (hiv) infection or positive immunoassay;
- Live vaccination within 30 days prior to study drug administration;
- Active autoimmune disease requiring systemic therapy in the last 12 months
- Allergy to the study drug or history of severe allergic reactions
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- Potential risk of malignant cardiac arrhythmia
- History of stroke or intracranial hemorrhage within 3 months prior to the date of administration of study medication
- Other malignant tumors presently or within 3 years prior to enrollment
- Conditions that, in the judgment of the investigator, would interfere with full participation in the study; pose a significant risk to the subject; or interfere with the interpretation of the study data
- Pregnant or lactating patients;
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Beljing Tiantan Hospital, Capttal Medical, University
Beijing
Yuanbo Liu
- Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing
Wanling Sun
- Not yet recruiting
Sun Yat-Sen University Cancer Center
Guangzhou
Zhiming Li
- Not yet recruiting
Henan Cancer Hospital
Henan
Keshu Zhou
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Wenyan Yu
Jianqing Mi
- Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
Wuhan
Yi Xiao
About this study
Official title: Relmacabtagene Autoleucel Injection Followed by Tislelizumab for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma Involved in the Central Nervous System
This study aims to evaluate the efficacy and safety of Relma-cel in the treatment of central nervous system lymphoma (CNSL), as well as its pharmacokinetic characteristics. Enrolled patients with relapsed/refractory (R/R) CNSL will receive Relma-cel infusion, followed by Tislelizumab treatment (200mg, IV, q4w, for 12 months) starting on day 35 after infusion. Bruton's tyrosine kinase (BTK) inhibitors will be used in combination as needed. The follow-up period will last for 4 years, monitoring drug safety, disease status, survival, and the pharmacokinetic characteristics of Relma-cel.
- Conditions
- CNS Lymphoma
- Being tested
- Relma-cel Followed by Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relma-cel Followed by TislelizumabDrug
Enrolled patients with relapsed/refractory (R/R) CNSL will receive Relma-cel infusion, followed by treatment with Tislelizumab (200mg, IV, q4w, for 12 months) starting at 35 days post-infusion. BTK inhibitors will be used in combination as needed.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Relma-cel Followed by Tislelizumab Receives: Drug: Relma-cel Followed by Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate(CRR) at 3-month
Complete response rate at 3-month is defined as the incidence of subjects achieving complete response (CR) at 3-month after CAR-T infusion according to the Lugano Classification, as determined by study investigators.
Measured: 3 months post CAR-T infusion
Secondary outcomes (3)
Progression-Free Survival (PFS)
PFS is defined as the time from the CAR-T infusion date to the date of disease progression or death from any cause.
Measured: 2 years post CAR-T infusion
Overall Survival (OS)
OS is defined as the time from CAR-T infusion to the date of death from any cause.
Measured: 2 years post CAR-T infusion
Objective remission rate (ORR) at 3-month
Objective remission rate (ORR) at 3-month is defined as the incidence of either a CR or a partial response (PR) at 3-month after CAR-T infusion per the Lugano Classification as determined by study investigators
Measured: 3 months post CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start30 Nov 2023
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876688
- Sponsor's protocol ID
- CNSL-CART
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relmacabtagene Autoleucel Injection Followed by Tislelizumab for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma Involved in the Central Nervous System
- ClinicalTrials.gov ID
- NCT06876688
- Acronym / sponsor ID
- CNSL-CART
- Conditions
- CNS Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of Relma-cel in the treatment of central nervous system lymphoma (CNSL), as well as its pharmacokinetic characteristics. Enrolled patients with relapsed/refractory (R/R) CNSL will receive Relma-cel infusion, followed by Tislelizumab treatment (200mg, IV, q4w, for 12 months) starting on day 35 after infusion. Bruton's tyrosine kinase (BTK) inhibitors will be used in combination as needed. The follow-up period will last for 4 years, monitoring drug safety, disease status, survival, and the pharmacokinetic characteristics of Relma-cel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Relma-cel Followed by TislelizumabRelma-cel Followed by Tislelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age greater than or equal to 18 years old, male or female;
- Relapsed or refractory CNS-involved large b-cell lymphoma after at least first-line therapy, with an efficacy assessment of CR or PR after salvage therapy, and current stable efficacy status;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- Have a life expectancy of ≥ 12 weeks
- Use contraception
Key exclusion criteria (11 listed)
- Severe active central nervous system symptoms
- Prior chimeric antigen receptor cellular immunotherapy targeting cd19
- Known human immunodeficiency virus (hiv) infection or positive immunoassay;
- Live vaccination within 30 days prior to study drug administration;
- Active autoimmune disease requiring systemic therapy in the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relma-cel Followed by TislelizumabEnrolled patients with relapsed/refractory (R/R) CNSL will receive Relma-cel infusion, followed by treatment with Tislelizumab (200mg, IV, q4w, for 12 months) starting at 35 days post-infusion. BTK inhibitors will be used in combination as needed. | Drug | intervention group |
Primary outcome
Complete response rate(CRR) at 3-month
Time frame: 3 months post CAR-T infusion
Complete response rate at 3-month is defined as the incidence of subjects achieving complete response (CR) at 3-month after CAR-T infusion according to the Lugano Classification, as determined by study investigators.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2 years post CAR-T infusion
Overall Survival (OS)
Time frame: 2 years post CAR-T infusion
Objective remission rate (ORR) at 3-month
Time frame: 3 months post CAR-T infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Relma-cel Followed by Tislelizumab in people with CNS Lymphoma, run by Ruijin Hospital at 6 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 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: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Contact Wenyan Yu (+86 13564230293, 1152227516@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate(CRR) at 3-month (time frame: 3 months post CAR-T infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2025.