Allogeneic, CAR-T, Protein Sequestration, Non-gene EditedPhase 1NCT05640713
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy
A Phase 1 study testing ThisCART19A, Fludarabine Pill and Cyclophosphamide in people with Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy in china. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited
- What is being tested?
- ThisCART19A, Fludarabine Pill and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Aug 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
- Patient with relapsed or refractory acute lymphocytic leukemia, or lymphoma；
- No gender limitation, Age 14 years to 75 years (both upper and lower limits included)；
- Failing to autologous CAR-T therapy；
- Should be confirmed Cluster of differentiation(CD)19 positive；
- The expected survival time is ≥12 weeks;
- ECOG score 0-1;
- Measurable or detectble disease at time of enrollment.
- Adequate bone marrow, renal, hepatic, pulmonary and cardiac function；
Who cannot join
- Allergic to preconditioning measures；
- Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients 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；
- Uncontrollable bacterial, fungal and viral infection during screening；
- Patients had pulmonary embolism (PE) and/or deep vein thrombosis (DVT) within 3 months prior to enrollment;
- Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment；
- The presence of central nervous system involvement；
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- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA < 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment；
- Had big lesion(single lesion diameter ≥10 cm)；
- Receive allogeneic hematopoietic stem cell transplantation less than 100 days；
- Vaccinated with influenza vaccine within 2 weeks prior to cleansing (SARS-COV19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included)；
- Patients who are receiving GvHD treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion；
- Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose-escalation Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Targeting CD19 (ThisCART19A) in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy
This is a a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy in china.
Read the detailed description
This is a phase 1, single-center, nonrandomized, open-label, dose-escalation and dose expansion study to evaluate the safety and efficacy of ThisCART19A in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile.
- Being tested
- ThisCART19A, Fludarabine Pill, Cyclophosphamide, VP-16 Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThisCART19ADrug
ThisCART19A is a new type CAR-T therapy for patients with r/r B Cell Malignancy .
Fludarabine PillDrug
Fludarabine is used for lymphodepletion.
CyclophosphamideDrug
Cyclophosphamide is used for lymphodepletion.
VP-16 ProtocolDrug
VP-16 is used for lymphodepletion.
| Study group | Role | What they receive |
|---|---|---|
| ThisCART19A cells infusion | Experimental | In this study, allogeneic anti-CD19 CAR T cell (ThisCART19A) infusion is used to treat patients with refractory or relapsed CD19 positive B cell acute lymphoblastic leukemia. Receives: Drug: ThisCART19A; Drug: Fludarabine Pill; Drug: Cyclophosphamide; Drug: VP-16 Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicity(DLT) observation in patient with B Cell Malignancy in each dose level during dose escalation stage
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Measured: 28 days
Objective Response Rate within 3 months during dose expansion stage
For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve Complete Response (CR) or Complete Response With Incomplete Hematologic Recovery (CRi); for lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR).
Measured: 3 months
Minimum Residual Disease (MRD) Negative Remission Rate within 3 months during dose expansion stage
MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. Percentage of participants with MRD negative remission was reported.
Measured: 3 months
Secondary outcomes (4)
Duration of response(DOR) during dose escalation stage and expansion stage
DOR was defined as the time from first CR/CRi or PR to relapse or any death in the absence of documented relapse.
Measured: 24 months
Relapse-free Survival (RFS)
RFS is defined as the time from the date of ThisCART19A infusion to the date of disease relapse or death from any cause.
Measured: 24 months
Event-free Survival (EFS)
EFS is defined as the time from the date of ThisCART19A infusion to the date of disease relapse, progression, genetic relapse or death from any cause.
Measured: 24 months
Overall Survival (OS)
OS is defined as the time from the date of ThisCART19A infusion to the date of death from any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic, CAR-T, Protein Sequestration, Non-gene EditedStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Fundamenta Therapeutics, Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640713
- Sponsor's protocol ID
- ThisCART19A （FT400-011）
- Status last verified
- Nov 2022
- First submitted
- 28 Nov 2022
- Last updated
- 7 Dec 2022
- 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 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose-escalation Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Targeting CD19 (ThisCART19A) in Adult Patients With B Cell Malignancies After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy
- ClinicalTrials.gov ID
- NCT05640713
- Acronym / sponsor ID
- ThisCART19A （FT400-011）
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Fundamenta Therapeutics, Ltd.
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 7 Dec 2022 (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 a phase 1, open label study to assess the safety and efficacy of ThisCART19 (Allogeneic CAR-T targeting CD19) in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy in china.
Detailed description
This is a phase 1, single-center, nonrandomized, open-label, dose-escalation and dose expansion study to evaluate the safety and efficacy of ThisCART19A in adult patients with B cell malignancies after failure of autologous chimeric antigen receptor T- cell(CAR-T) therapy and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ThisCART19A cells infusion | Experimental | Drug: ThisCART19A, Drug: Fludarabine Pill, Drug: Cyclophosphamide, Drug: VP-16 ProtocolIn this study, allogeneic anti-CD19 CAR T cell (ThisCART19A) infusion is used to treat patients with refractory or relapsed CD19 positive B cell acute lymphoblastic leukemia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with relapsed or refractory acute lymphocytic leukemia, or lymphoma；
- No gender limitation, Age 14 years to 75 years (both upper and lower limits included)；
- Failing to autologous CAR-T therapy；
- Should be confirmed Cluster of differentiation(CD)19 positive；
- The expected survival time is ≥12 weeks;
Key exclusion criteria (12 listed)
- Allergic to preconditioning measures；
- Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients 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；
- Uncontrollable bacterial, fungal and viral infection during screening；
- Patients had pulmonary embolism (PE) and/or deep vein thrombosis (DVT) within 3 months prior to enrollment;
- Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases 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 |
|---|---|---|
| ThisCART19AThisCART19A is a new type CAR-T therapy for patients with r/r B Cell Malignancy . | Drug | ThisCART19A cells infusion |
| Fludarabine PillFludarabine is used for lymphodepletion. | Drug | ThisCART19A cells infusion |
| CyclophosphamideCyclophosphamide is used for lymphodepletion. | Drug | ThisCART19A cells infusion |
| VP-16 ProtocolVP-16 is used for lymphodepletion. | Drug | ThisCART19A cells infusion |
Primary outcome
Dose limited toxicity(DLT) observation in patient with B Cell Malignancy in each dose level during dose escalation stage
Time frame: 28 days
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Objective Response Rate within 3 months during dose expansion stage
Time frame: 3 months
For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve Complete Response (CR) or Complete Response With Incomplete Hematologic Recovery (CRi); for lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR).
Minimum Residual Disease (MRD) Negative Remission Rate within 3 months during dose expansion stage
Time frame: 3 months
MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10^-4. MRD negative remission was defined as MRD < 10^-4 threshold. Percentage of participants with MRD negative remission was reported.
4 secondary outcomes
Duration of response(DOR) during dose escalation stage and expansion stage
Time frame: 24 months
Relapse-free Survival (RFS)
Time frame: 24 months
Event-free Survival (EFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
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, Fludarabine Pill and Cyclophosphamide in people with Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited, run by Henan Cancer 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 12 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 7 Dec 2022. 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 Keshu zhou, Dr. (+86-13674902391, drzhouks77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity(DLT) observation in patient with B Cell Malignancy in each dose level during dose escalation stage (time frame: 28 days). The study lists 3 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 7 Dec 2022.