Relapsed or Refractory B-cell LymphomaPhase 4NCT05814848
A Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma
A Phase 4 study testing Relmacabtagene Autoleucel Injection in people with Relapsed or Refractory B-cell Lymphoma, run by Changhai Hospital.
Trial summary
To evaluate the efficacy and safety of post-marketing Regiorense injection secondary infusion in the treatment of adult patients with relapsed or refractory B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory B-cell Lymphoma
- What is being tested?
- Relmacabtagene Autoleucel Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2023to 31 Mar 2028
- Phase
- Phase 4
- 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
- Informed Consent Form (ICF) was obtained from the patients.
- Diagnosed relapsed or refractory B-cell lymphomas
- diffuse large B-cell lymphoma-not otherwise specified
- diffuse large B-cell lymphoma transformed from follicular lymphoma
- grade 3b follicular lymphoma
- primary mediastinal large B-cell lymphoma
Show all 14Show fewer
- high-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangements (double/triple hit lymphoma)
- adult follicular lymphoma refractory to second-line or later systemic therapy or relapsed within 24 months Adult patients who had completed the first treatment with remifentanil injection;
- The patient had undergone at least one post-treatment disease assessment with Relmacabtagene Autoleucel Injection, and the investigator decided to retreat the patient (including PR\PD\SD) with commercially available Relmacabtagene Autoleucel injection based on clinical practice;
- Prior to the second infusion, an adequate dose of the manufactured product (80-150x106 CAR-T cells recommended) should be confirmed, at the investigator's discretion based on the patient's condition and dose stockpile；
- Confirmation of residual tumor tissue CD19+ in patients, if clinically permissible；
- Absence of antidrug antibody (ADA) to ricciolenz in plasma before retreatment；
- Toxicity associated with lymphocyte-clearing chemotherapy (fludarabine and cyclophosphamide), with the exception of alopecia, that resolved to ≤ grade 1 or returned to pre-first treatment levels before retreatment.
- The patients did not have serious adverse reactions during the first treatment, or the adverse reactions during the first treatment had resolved to the baseline level of the first treatment.
Who cannot join
- Patients with hypersensitivity to the active ingredient or any excipients (dimethyl sulfoxide, compound electrolyte injection, human serum albumin);
- Patients had uncontrolled systemic fungal, bacterial, viral, or other infections
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm Prospective Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma
To evaluate the efficacy and safety of post-marketing Regiorense injection secondary infusion in the treatment of adult patients with relapsed or refractory B-cell lymphoma.
Read the detailed description
CD19-targeted chimeric antigen receptor T-cell therapy has shown remarkable efficacy in relapsed or refractory B-cell malignancies. However, CD19 CAR-T cells are still unable to induce durable remissions in some patients. Further therapeutic strategies remain to be explored for patients who fail to achieve complete remission (CR) or who relapse after CAR-T treatment. the mechanisms underlying the failure of CAR-T cell therapy may be diverse and not yet fully understood. It may be due to the patient's own poor T-cell function, immunosuppressive tumour microenvironment, loss of tumour-targeting antigen expression with antitumour therapy, and compromised CAR-T renewal in vivo, or T-cell depletion due to the tumour microenvironment. It has recently been demonstrated that CAR-T cells become functionally depleted, or CAR lost, with sustained exposure to tumour antigen stimulation (Good, C, 2021). Extensive clinical experience suggests that CAR-T cell expansion and persistence are required to achieve a durable response. In patients requiring follow-up therapy after failure of the first CAR-T cell infusion (CART1), one option is a second infusion of CD19 CAR-T cells (CART2) for retreatment, and a second infusion of CD19 CAR-T cells (CART2) is considered a possible approach to improve prognosis.
- Conditions
- Relapsed or Refractory B-cell Lymphoma
- Being tested
- Relmacabtagene Autoleucel Injection
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relmacabtagene Autoleucel InjectionDrug
Also called CARTEYVA
For patients who had undergone at least one disease assessment after the first treatment of Relmacabtagene Autoleucel injection and whose disease status was not complete remission, the investigators decided to give the patients a second treatment of Relmacabtagene Autoleucel injection based on clinical practice, and the specific dosage was determined by the investigators according to the patient's condition and dose reserve.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | For patients who had undergone at least one disease assessment after the first treatment of Relmacabtagene Autoleucel injection and whose disease status was not complete remission, the investigators decided to give the patients a second treatment of Relmacabtagene Autoleucel injection based on clinical practice, and the specific dosage was determined by the investigators according to the patient's condition and dose reserve. Receives: Drug: Relmacabtagene Autoleucel Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective Response Rate (ORR) : The investigator-assessed best disease status of patients with relapsed or refractory B-cell lymphoma was the rate of Complete Response (CR) or Partial Response (PR) at 3 months after a second infusion of remifolenafil.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Jun 2023 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Changhai 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Chen, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814848
- Sponsor's protocol ID
- JWCAR029019
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Prospective Study of Secondary Infusion of Relmacabtagene Autoleucel Injection for Relapsed or Refractory B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05814848
- Acronym / sponsor ID
- JWCAR029019
- Conditions
- Relapsed or Refractory B-cell Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 18 Apr 2023 (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.
To evaluate the efficacy and safety of post-marketing Regiorense injection secondary infusion in the treatment of adult patients with relapsed or refractory B-cell lymphoma.
Detailed description
CD19-targeted chimeric antigen receptor T-cell therapy has shown remarkable efficacy in relapsed or refractory B-cell malignancies. However, CD19 CAR-T cells are still unable to induce durable remissions in some patients. Further therapeutic strategies remain to be explored for patients who fail to achieve complete remission (CR) or who relapse after CAR-T treatment. the mechanisms underlying the failure of CAR-T cell therapy may be diverse and not yet fully understood. It may be due to the patient's own poor T-cell function, immunosuppressive tumour microenvironment, loss of tumour-targeting antigen expression with antitumour therapy, and compromised CAR-T renewal in vivo, or T-cell depletion due to the tumour microenvironment. It has recently been demonstrated that CAR-T cells become functionally depleted, or CAR lost, with sustained exposure to tumour antigen stimulation (Good, C, 2021). Extensive clinical experience suggests that CAR-T cell expansion and persistence are required to achieve a durable response. In patients requiring follow-up therapy after failure of the first CAR-T cell infusion (CART1), one option is a second infusion of CD19 CAR-T cells (CART2) for retreatment, and a second infusion of CD19 CAR-T cells (CART2) is considered a possible approach to improve prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Relmacabtagene Autoleucel InjectionFor patients who had undergone at least one disease assessment after the first treatment of Relmacabtagene Autoleucel injection and whose disease status was not complete remission, the investigators decided to give the patients a second treatment of Relmacabtagene Autoleucel injection based on clinical practice, and the specific dosage was determined by the investigators according to the patient's condition and dose reserve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Informed Consent Form (ICF) was obtained from the patients.
- Diagnosed relapsed or refractory B-cell lymphomas
- The patient had undergone at least one post-treatment disease assessment with Relmacabtagene Autoleucel Injection, and the investigator decided to retreat the patient (including PR\PD\SD) with commercially available Relmacabtagene Autoleucel injection based on clinical practice;
- Prior to the second infusion, an adequate dose of the manufactured product (80-150x106 CAR-T cells recommended) should be confirmed, at the investigator's discretion based on the patient's condition and dose stockpile；
- Confirmation of residual tumor tissue CD19+ in patients, if clinically permissible；
Key exclusion criteria (2 listed)
- Patients with hypersensitivity to the active ingredient or any excipients (dimethyl sulfoxide, compound electrolyte injection, human serum albumin);
- Patients had uncontrolled systemic fungal, bacterial, viral, or other infections
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 |
|---|---|---|
| Relmacabtagene Autoleucel InjectionAlso: CARTEYVAFor patients who had undergone at least one disease assessment after the first treatment of Relmacabtagene Autoleucel injection and whose disease status was not complete remission, the investigators decided to give the patients a second treatment of Relmacabtagene Autoleucel injection based on clinical practice, and the specific dosage was determined by the investigators according to the patient's condition and dose reserve. | Drug | single arm |
Primary outcome
Objective Response Rate
Time frame: three months
Objective Response Rate (ORR) : The investigator-assessed best disease status of patients with relapsed or refractory B-cell lymphoma was the rate of Complete Response (CR) or Partial Response (PR) at 3 months after a second infusion of remifolenafil.
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 15 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Relapsed or Refractory B-cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
RecruitingPhase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Active, not recruitingPhase 1
A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma
Non-Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Relapsed
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.
Li Chen principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Relmacabtagene Autoleucel Injection in people with Relapsed or Refractory B-cell Lymphoma, run by Changhai Hospital.
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 14 inclusion and 2 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: opening soon, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Li Chen (+8615026562366, yuhe0628@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: three months). 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 15 Jun 2023.