Hodgkin's LymphomaPhase 1NCT06494371
A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
A Phase 1 study testing LCAR-HL30 cells in people with Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a prospective, single-arm, open-label, exploratory clinical study of LCAR-HL30 in adult subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hodgkin's Lymphoma, Anaplastic Large Cell Lymphoma
- What is being tested?
- LCAR-HL30 cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Jul 2024to Aug 2028
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in clinical research.
- Aged 18 to 75 years, either sex.
- Eastern Cooperative Oncology Group (ECOG) score 0-1 (Dose escalation phase). ECOG score 0-2 (Dose expansion period).
- Histologically confirmed Hodgkin's lymphoma or Anaplastic large cell lymphoma with positive CD30 expression.
- At least one evaluable tumor lesion according to Lugano 2014 criteria.
- Expected survival ≥3 months.
- Clinical laboratory values in the screening period meet criteria.
- Effective contraception.
Who cannot join
- Prior antitumor therapy with insufficient washout period.
- Previous treatment with CAR-T therapy, allogeneic hematopoietic stem cell transplantation.
- Severe underlying diseases;
- Hepatitis B virus surface antigen (HbsAg), Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive.
- Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Wenyan Yu
Jianqing Mi
About this study
Official title: An Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of CD30-Targeted LCAR-HL30 Cells in Patients With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
This is a prospective, single-arm, open-label, exploratory clinical study of LCAR-HL30 in adult subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma.
Read the detailed description
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LCAR-HL30, a chimeric antigen receptor(CAR)-T cell therapy in subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma. Patients who meet the eligibility criteria will receive LCAR-HL30 infusion. The study will include the following sequential stages: screening, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment and follow-up.
- Conditions
- Hodgkin's Lymphoma, Anaplastic Large Cell Lymphoma
- Being tested
- LCAR-HL30 cells
- Keywords
- Hodgkin's Lymphoma, Anaplastic Large Cell Lymphoma
- Medical subject headings
- Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCAR-HL30 cellsBiological
Prior to infusion of the LCAR-HL30, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine
| Study group | Role | What they receive |
|---|---|---|
| Chimeric antigen receptor T cells LCAR-HL30 cells | Experimental | Each subject will receive LCAR-HL30 cells. Receives: Biological: LCAR-HL30 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR positive T cells levels in peripheral blood after LCAR-HL30 infusion.
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR transgene levels in peripheral blood after LCAR-HL30 infusion.
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Pharmacokinetics in bone marrow
CAR positive T cells levels in bone marrow after LCAR-HL30 infusion.
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Pharmacokinetics in bone marrow
CAR transgene levels in bone marrow after LCAR-HL30 infusion.
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Recommended Phase 2 Dose (RP2D) regimen finding
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Secondary outcomes (6)
Objective Response Rate (ORR) after administration
ORR is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment via LCAR-HL30 cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per the Lugano Classification for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma (Lugano 2014).
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Time to Response (TTR) after administration
TTR is defined as the time from the date of first infusion of LCAR-HL30 to the date of the first response evaluation of the subject who has met all criteria for PR or better.
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Duration of Remission (DoR) after administration
DoR is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to Lugano 2014) of the responders (who achieve PR or better response).
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Progression-free Survival (PFS) after administration
PFS is defined as the time from the date of first infusion of the LCAR-HL30 to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first.
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Overall Survival (OS) after administration
OS is defined as the time from the date of first infusion of LCAR-HL30 to death of the subject.
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Incidence of anti-LCAR-HL30 antibody
The incidence of anti-LCAR-HL30 antibody in patients who received LCAR-HL30 infusion.
Measured: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494371
- Sponsor's protocol ID
- LB2203-0001
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 10 Jul 2024
- 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of CD30-Targeted LCAR-HL30 Cells in Patients With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06494371
- Acronym / sponsor ID
- LB2203-0001
- Conditions
- Hodgkin's Lymphoma, Anaplastic Large Cell Lymphoma
- Keywords
- Hodgkin's Lymphoma, Anaplastic Large Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Study start
- Jul 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 10 Jul 2024 (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 is a prospective, single-arm, open-label, exploratory clinical study of LCAR-HL30 in adult subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma.
Detailed description
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LCAR-HL30, a chimeric antigen receptor(CAR)-T cell therapy in subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma. Patients who meet the eligibility criteria will receive LCAR-HL30 infusion. The study will include the following sequential stages: screening, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chimeric antigen receptor T cells LCAR-HL30 cells | Experimental | Biological: LCAR-HL30 cellsEach subject will receive LCAR-HL30 cells. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily participate in clinical research.
- Aged 18 to 75 years, either sex.
- Eastern Cooperative Oncology Group (ECOG) score 0-1 (Dose escalation phase). ECOG score 0-2 (Dose expansion period).
- Histologically confirmed Hodgkin's lymphoma or Anaplastic large cell lymphoma with positive CD30 expression.
- At least one evaluable tumor lesion according to Lugano 2014 criteria.
Key exclusion criteria (5 listed)
- Prior antitumor therapy with insufficient washout period.
- Previous treatment with CAR-T therapy, allogeneic hematopoietic stem cell transplantation.
- Severe underlying diseases;
- Hepatitis B virus surface antigen (HbsAg), Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive.
- Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
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 |
|---|---|---|
| LCAR-HL30 cellsPrior to infusion of the LCAR-HL30, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine | Biological | Chimeric antigen receptor T cells LCAR-HL30 cells |
Primary outcome
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Pharmacokinetics in peripheral blood
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
CAR positive T cells levels in peripheral blood after LCAR-HL30 infusion.
Pharmacokinetics in peripheral blood
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
CAR transgene levels in peripheral blood after LCAR-HL30 infusion.
Pharmacokinetics in bone marrow
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
CAR positive T cells levels in bone marrow after LCAR-HL30 infusion.
Pharmacokinetics in bone marrow
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
CAR transgene levels in bone marrow after LCAR-HL30 infusion.
Recommended Phase 2 Dose (RP2D) regimen finding
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
6 secondary outcomes
Objective Response Rate (ORR) after administration
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Time to Response (TTR) after administration
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Duration of Remission (DoR) after administration
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Progression-free Survival (PFS) after administration
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Overall Survival (OS) after administration
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
Incidence of anti-LCAR-HL30 antibody
Time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
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 10 Jul 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LCAR-HL30 cells in people with Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma, run by Ruijin Hospital 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 8 inclusion and 5 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 10 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jianqing Mi (13524488296, jianqingmi@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and type of treatment-emergent adverse events (TEAEs) (time frame: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)). The study lists 6 primary outcomes in all. 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 10 Jul 2024.