CARPhase 1NCT05691153
ThisCART19A for B-NHL Relapsed After Auto-CAR T
A Phase 1 study testing ThisCART19A with Dose Level 1 and ThisCART19A with Dose Level 2 in people with CAR and B Cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A (allogeneic CAR-T targeting CD19) in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CAR, B Cell Lymphoma, Relapsed Non-Hodgkin Lymphoma
- What is being tested?
- ThisCART19A with Dose Level 1 and ThisCART19A with Dose Level 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 30 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Voluntarily sign a documented IRB-approved ICF prior to any screening procedure;
- Gender not restricted, 18 years ≤ age ≤ 75 years;
- Subjects with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma;
- Life expectancy ≥ 12 weeks at the time of enrollment;
- Eastern Cooperative Oncology Group performance status score of 0 or 1;
- At least one measurable lesion to be assessed, with any nodal lesion > 15mm in LDi (longest diameter) and any extranodal lesion > 10mm in LDi;
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- Subject has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
- Adequate marrow function for lymphodepletion chemotherapy: 14 days before enrollment, absolute neutrophil count (ANC) ≥ 1×10^9/L, platelet count ≥ 30×10^9/L, hemoglobin ≥ 80 g/L without blood transfusion;
- Creatinine clearance ≥ 30 ml/min according to the Cockcroft-Gault formula, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × the upper limit of normal (ULN), total bilirubin ≤ 2×ULN (Subjects with Gilbert syndrome or liver involvement may be enrolled if their total bilirubin is ≤ 3×ULN);
- Pulmonary function: Baseline oxygen saturation (SaO2) ≥ 92% on room air;
- Cardiac function：left ventricular ejection fraction (LVEF) ≥ 40% assessed by echocardiography.
- CD19-positive lymphoma confirmed on a biopsy during screening.
Who cannot join
- Allergic to preconditioning measures in the trial.
- Other malignancies apart from B-cell malignancies within 5 years prior to screening. (Subjects with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.)
- Severe active infection (Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted).
- Pulmonary embolism (PE) within 3 months prior to enrollment.
- Intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases assessed by the investigator prior to enrollment.
- Gastrointestinal involvement at risk of active bleeding.
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- Massive pericardial effusion, symptomatic thoracic or abdominal effusion.
- Presence of CNS involvement (both primary and secondary) at screening confirmed by imaging or CSF testing.
- Active hepatitis B virus (serum HBV-DNA ≥ 2000 IU/mL), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or active syphilis infection prior to enrollment. (Patients with HBV-DNA < 2000 IU/mL can be enrolled, but should be administered antiviral drugs such as entecavir and tenofovir with relative clinical indicators monitored simultaneously during the treatment.)
- Less than 100 days after allogeneic hematopoietic stem cell transplantation.
- Vaccinated with influenza vaccine within 2 weeks prior to lymphodepletion chemotherapy. (Patients vaccinated with SARS-COV19 vaccine or inactivated; live/non-live adjuvant vaccines can be enrolled.)
- Under treatment for graft versus host disease (GvHD). (GvHD cured subjects who had stopped immunosuppressive drugs for at least 1 month can be enrolled.)
- Female subjects who are pregnant, breastfeeding or planning for pregnancy within 1 year after CAR-T cell infusion, or male subjects whose partners are planning for pregnancy within 1 year after CAR-T cell infusion;
- Any conditions that would, in the investigator's assessment, increase risks in patients or interfere with the outcomes of the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Depei Wu, +86 13951102021, drwudepei@163.com
About this study
Official title: A Single-center, Dose Selection Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Allogeneic CAR-T Targeting CD19 in Patients With Auto-CAR T Relapsed B-cell Non-Hodgkin's Lymphoma
This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A (allogeneic CAR-T targeting CD19) in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma.
Read the detailed description
This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma. The study will identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile. Before initiating ThisCART19A infusion, subjects will be administered lymphodepletion chemotherapy composed of fludarabine、cyclophosphamide and VP-16. At Day 0 of the Treatment Period, subjects will receive an intravenous (IV) infusion of ThisCART19A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of ThisCART19A will be followed up to 2 years.
- Conditions
- CAR, B Cell Lymphoma, Relapsed Non-Hodgkin Lymphoma
- Being tested
- ThisCART19A with Dose Level 1, ThisCART19A with Dose Level 2
- Keywords
- Universal CAR-T
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThisCART19A with Dose Level 1Drug
Also called ThisCART19A with 2×10^6 cells/kg
ThisCART19A，2×10^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）, after the lymphodepletion conditioning of fludarabine, CTX and VP-16
ThisCART19A with Dose Level 2Drug
Also called ThisCART19A with 3×10^6 cells/kg
ThisCART19A，3×10^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）, after the lymphodepletion conditioning of fludarabine, CTX and VP-16
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | ThisCART19A，2×10^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused） Receives: Drug: ThisCART19A with Dose Level 1 |
| Dose Level 2 | Experimental | ThisCART19A，3×10^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused） Receives: Drug: ThisCART19A with Dose Level 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOR
Best Overall Response Rate
Measured: 3 month
Secondary outcomes (7)
ORR
Objective response rate
Measured: 2 year
CR
Complete response rate
Measured: 2 year
TTR
Time to response
Measured: 3 month
DOR
Duration of response
Measured: 2 year
EFS
Event-free survival
Measured: 2 year
PFS
Progression-free survival
Measured: 2 year
OS
Overall survival
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Dec 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CARStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fundamenta Therapeutics, Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691153
- Sponsor's protocol ID
- SZ5602
- Status last verified
- Dec 2022
- First submitted
- 27 Dec 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Dose Selection Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Allogeneic CAR-T Targeting CD19 in Patients With Auto-CAR T Relapsed B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT05691153
- Acronym / sponsor ID
- SZ5602
- Conditions
- CAR, B Cell Lymphoma, Relapsed Non-Hodgkin Lymphoma
- Keywords
- Universal CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Fundamenta Therapeutics, Ltd.
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 19 Jan 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.
This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A (allogeneic CAR-T targeting CD19) in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma.
Detailed description
This is a phase 1, single-center, dose selection study to evaluate the efficacy, safety, and pharmacokinetics of ThisCART19A in patients with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma. The study will identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile. Before initiating ThisCART19A infusion, subjects will be administered lymphodepletion chemotherapy composed of fludarabine、cyclophosphamide and VP-16. At Day 0 of the Treatment Period, subjects will receive an intravenous (IV) infusion of ThisCART19A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of ThisCART19A will be followed up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: ThisCART19A with Dose Level 1ThisCART19A，2×10^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused） |
| Dose Level 2 | Experimental | Drug: ThisCART19A with Dose Level 2ThisCART19A，3×10^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused） |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily sign a documented IRB-approved ICF prior to any screening procedure;
- Gender not restricted, 18 years ≤ age ≤ 75 years;
- Subjects with Auto-CAR T relapsed B-cell non-Hodgkin's lymphoma;
- Life expectancy ≥ 12 weeks at the time of enrollment;
- Eastern Cooperative Oncology Group performance status score of 0 or 1;
Key exclusion criteria (14 listed)
- Allergic to preconditioning measures in the trial.
- Other malignancies apart from B-cell malignancies within 5 years prior to screening. (Subjects with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited.)
- Severe active infection (Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted).
- Pulmonary embolism (PE) within 3 months prior to enrollment.
- Intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases assessed by the investigator prior to enrollment.
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 |
|---|---|---|
| ThisCART19A with Dose Level 1Also: ThisCART19A with 2×10^6 cells/kgThisCART19A，2×10^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）, after the lymphodepletion conditioning of fludarabine, CTX and VP-16 | Drug | Dose Level 1 |
| ThisCART19A with Dose Level 2Also: ThisCART19A with 3×10^6 cells/kgThisCART19A，3×10^6 cells/kg（Single dose of Allogeneic Anti-CD19 CAR T cells will be infused）, after the lymphodepletion conditioning of fludarabine, CTX and VP-16 | Drug | Dose Level 2 |
Primary outcome
BOR
Time frame: 3 month
Best Overall Response Rate
7 secondary outcomes
ORR
Time frame: 2 year
CR
Time frame: 2 year
TTR
Time frame: 3 month
DOR
Time frame: 2 year
EFS
Time frame: 2 year
PFS
Time frame: 2 year
OS
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 ThisCART19A with Dose Level 1 and ThisCART19A with Dose Level 2 in people with CAR and B Cell Lymphoma, run by The First Affiliated Hospital of Soochow University 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 12 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Chen, M.D., Ph.D. (+86-512-67781856, drchenjia@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOR (time frame: 3 month). 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 19 Jan 2023.