Refractory or Relapsed B Cell LymphomaPhase 1/2NCT05776407
Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With Refractory or Relapsed B Cell Lymphoma
A Phase 1/2 study testing ThisCART19A, Fludarabine and Cyclophosphamide in people with Refractory or Relapsed B Cell Lymphoma, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
This is a phase 1/2, open-label study to assess the efficacy, safety and pharmacokinetics of ThisCART19A (Allogeneic Anti CD19 CAR-T) in patients with refractory or relapsed CD19 positive B cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Refractory or Relapsed B Cell Lymphoma
- What is being tested?
- ThisCART19A, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- May 2023to Nov 2024
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years ≤ age ≤ 65 years.
- Voluntarily sign a documented IRB-approved ICF prior to any screening procedure.
- Patients with histologically confirmed B-cell NHL defined by the World Health Organization (WHO) 2016, including but not limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma transferring to DLBCL, mantle cell lymphoma (MCL), follicular lymphoma 3B (FL-3B), original Mediastinal (thymus) large B-cell lymphoma, high-grade B-cell lymphoma and AIDS-associated B-cell lymphoma.
- Prior therapy must have included: Anti-CD20 monoclonal antibody and Anthracycline containing chemotherapy regimen.
- Had available evaluation lesion.
- ECOG(Eastern Cooperative Oncology Group) ≤ 2 or Karnofsky ≥ 60%.
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- Serum creatinine≤1.5×ULN or creatinine clearance>30 mL/min/1.73 m2.
- Alanine aminotransferase(ALT)≤5×ULN(Upper limit of normal) and total bilirubin(TBIL)<2.0 mg/dL(for patients with Gilbert heald diseases, live involvement and taking atazanavir or indinavir, TBIL<3.0 mg/dL can be enrolled.)
- Left ventricular ejection fraction(LVEF)≥40%
- Absolute neutrophile counts≥1000/mm3
- Thrombocyte≥30000/mm3
- Total bilirubin(TBIL) ≤ 2.0 mg/dL
- Confirmed Cluster of differentiation(CD)19 positive by biopsy for the patients who received CD19 target therapy before.
- Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.
- AIDS Related B Cell Lymphoma :HIV virus loading < 200 copy/ml and CD4+T cell counts >200 cells/mm3 within 4 weeks before screening.
- Patients with TBIL≤ 1.5 mg/dL, Aspartate aminotransferase(AST) and ALT ≤ 3×ULN, and hepatitis B virus(HBV) DNA <2000 IU/ml can be enrolled for HBV positive patients(defined as hepatitis B virus surface antigen(HBsAg) positive and hepatitis B core(HBc)-total positive ) and hepatitis C virus(HCV) positive patients(defined as HCV antibody positive) . Patients with cirrhosis are excluded.
- Hepatitis B core antibody(HBcAb) positive patients enrolled in this trial have to taking anti-HBV drugs during the whole research.
Who cannot join
- Known for allergic to the preconditioning measures.
- Uncontrollable bacterial, fungal, viral infection before enrollment.
- Patients with pulmonary embolism within 3 months prior enrollment.
- Intolerable serious cardiovascular and cerebrovascular diseases and hereditary diseases.
- Imaging confirmed the presence of central nervous system involvement(including primary and secondary) and rapid progressing diseases.
- Receive allogeneic hematopoietic stem cell transplantation less than 100 days.
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- Systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. iIntermittent use of topical, inhaled or intranasal steroids recently or currently. Or systemic disease requiring long-term use of immunosuppression drugs.
- Excluded the patients received Influenza vaccinations within 2 weeks prior to lymphodepletion (Received Severe Acute Respiratory Syndrome-Corona virus disease(SARS-COV)19 vaccines could be included. Received inactivated, live/non-live adjuvant vaccines could be enrolled).
- Excluded women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after infusion. Male subjects planning pregnancy within 1 year after infusion should be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
About this study
Official title: A Single Dose-escalation and Dose-expansion Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Allogeneic CAR-T Targeting CD19 in Patients With Refractory or Relapsed B Cell Lymphoma.
This is a phase 1/2, open-label study to assess the efficacy, safety and pharmacokinetics of ThisCART19A (Allogeneic Anti CD19 CAR-T) in patients with refractory or relapsed CD19 positive B cell Lymphoma.
Read the detailed description
This is a phase 1/2, single-center, nonrandomized, open-label, dose-escalation and dose-expansion study to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A in patients with r/r CD19 positive B cell Lymphoma and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile. AIDS-related B-cell lymphoma were not excluded from this clinical trial.
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 42. All subjects who receive a dose of ThisCART19A will be followed up to 2 years.
- Conditions
- Refractory or Relapsed B Cell Lymphoma
- Being tested
- ThisCART19A, Fludarabine, Cyclophosphamide, Etoposide
- Keywords
- Allogeneic CAR T，B cell Lymphoma
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThisCART19ADrug
Also called Allogeneic Anti-CD19 CAR T cells
Single dose of Allogeneic Anti-CD19 CAR T cells (ThisCART19A) will be infused after the lymphodepletion conditioning of Fludarabine, Cyclophosphamide and Etoposide.
FludarabineDrug
Fludarabine is used for lymphodepletion.
CyclophosphamideDrug
Cyclophosphamide is used for lymphodepletion.
EtoposideDrug
Also called VP-16
Etoposide is used for lymphodepletion.
| Study group | Role | What they receive |
|---|---|---|
| ThisCART19A cells infusion | Experimental | In this study, allogeneic anti-CD19 CAR T cells (ThisCART19A) infusion is used to treat patients with r/r B cell Lymphoma. Receives: Drug: ThisCART19A; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Etoposide |
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 r/r B cell Lymphoma
DLT was defined as CAR T cells-related events with onset within first 28 days following infusion.
Measured: 28 days
The incidence of all grade TEAEs and ≥3 grade TEAEs
Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs
Measured: Up to 2 years after ThisCART19A infusion
Objective Response Rate
the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment.
Measured: Up to 2 years after ThisCART19A infusion
Duration of response (DOR)
DOR is defined as the date of their first CR or PR (which is subsequently confirmed) to PD assessed by investigators and based on the Lugano 2014 assessment criterion for r/r B cell Lymphoma, or death regardless of cause.
Measured: Up to 2 years after ThisCART19A infusion
Progress-free survival (PFS)
PFS is defined as the time from the ThisCART19A infusion date to the date of disease progression assessed by investigators and based on the Lugano 2014 assessment criterion, or death any cause.
Measured: Up to 2 years after ThisCART19A infusion
Secondary outcomes (2)
TTR (Time to response)
TTR is defined as the time from ThisCART19A infusion to first assessed CR or PR based on the Lugano 2014 assessment criterion.
Measured: Up to 2 years after ThisCART19A infusion
OS (Overall survival)
Overall survival (OS) is defined as the time from the date of lymphodepletion until death from any cause.
Measured: Up to 2 years after lymphodepletion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory or Relapsed B Cell LymphomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundamenta Therapeutics, Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776407
- Sponsor's protocol ID
- FT400-006-2
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 20 Mar 2023
- Results posted
- 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 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose-escalation and Dose-expansion Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Allogeneic CAR-T Targeting CD19 in Patients With Refractory or Relapsed B Cell Lymphoma.
- ClinicalTrials.gov ID
- NCT05776407
- Acronym / sponsor ID
- FT400-006-2
- Conditions
- Refractory or Relapsed B Cell Lymphoma
- Keywords
- Allogeneic CAR T，B cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Collaborators
- Fundamenta Therapeutics, Ltd.
- Study start
- May 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 20 Mar 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 1/2, open-label study to assess the efficacy, safety and pharmacokinetics of ThisCART19A (Allogeneic Anti CD19 CAR-T) in patients with refractory or relapsed CD19 positive B cell Lymphoma.
Detailed description
This is a phase 1/2, single-center, nonrandomized, open-label, dose-escalation and dose-expansion study to evaluate the efficacy, safety and pharmacokinetics of ThisCART19A in patients with r/r CD19 positive B cell Lymphoma and identify a treatment regimen most likely to result in clinical efficacy while maintaining a favorable safety profile. AIDS-related B-cell lymphoma were not excluded from this clinical trial.
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 42. All subjects who receive a dose of ThisCART19A will be followed up to 2 years.
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, Drug: Cyclophosphamide, Drug: EtoposideIn this study, allogeneic anti-CD19 CAR T cells (ThisCART19A) infusion is used to treat patients with r/r B cell Lymphoma. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 18 years ≤ age ≤ 65 years.
- Voluntarily sign a documented IRB-approved ICF prior to any screening procedure.
- Patients with histologically confirmed B-cell NHL defined by the World Health Organization (WHO) 2016, including but not limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma transferring to DLBCL, mantle cell lymphoma (MCL), follicular lymphoma 3B (FL-3B), original Mediastinal (thymus) large B-cell lymphoma, high-grade B-cell lymphoma and AIDS-associated B-cell lymphoma.
- Prior therapy must have included: Anti-CD20 monoclonal antibody and Anthracycline containing chemotherapy regimen.
- Had available evaluation lesion.
Key exclusion criteria (9 listed)
- Known for allergic to the preconditioning measures.
- Uncontrollable bacterial, fungal, viral infection before enrollment.
- Patients with pulmonary embolism within 3 months prior enrollment.
- Intolerable serious cardiovascular and cerebrovascular diseases and hereditary diseases.
- Imaging confirmed the presence of central nervous system involvement(including primary and secondary) and rapid progressing diseases.
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 |
|---|---|---|
| ThisCART19AAlso: Allogeneic Anti-CD19 CAR T cellsSingle dose of Allogeneic Anti-CD19 CAR T cells (ThisCART19A) will be infused after the lymphodepletion conditioning of Fludarabine, Cyclophosphamide and Etoposide. | Drug | ThisCART19A cells infusion |
| FludarabineFludarabine is used for lymphodepletion. | Drug | ThisCART19A cells infusion |
| CyclophosphamideCyclophosphamide is used for lymphodepletion. | Drug | ThisCART19A cells infusion |
| EtoposideAlso: VP-16Etoposide is used for lymphodepletion. | Drug | ThisCART19A cells infusion |
Primary outcome
Dose limited toxicity(DLT) observation in patient with r/r B cell Lymphoma
Time frame: 28 days
DLT was defined as CAR T cells-related events with onset within first 28 days following infusion.
The incidence of all grade TEAEs and ≥3 grade TEAEs
Time frame: Up to 2 years after ThisCART19A infusion
Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs
Objective Response Rate
Time frame: Up to 2 years after ThisCART19A infusion
the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment.
Duration of response (DOR)
Time frame: Up to 2 years after ThisCART19A infusion
DOR is defined as the date of their first CR or PR (which is subsequently confirmed) to PD assessed by investigators and based on the Lugano 2014 assessment criterion for r/r B cell Lymphoma, or death regardless of cause.
Progress-free survival (PFS)
Time frame: Up to 2 years after ThisCART19A infusion
PFS is defined as the time from the ThisCART19A infusion date to the date of disease progression assessed by investigators and based on the Lugano 2014 assessment criterion, or death any cause.
2 secondary outcomes
TTR (Time to response)
Time frame: Up to 2 years after ThisCART19A infusion
OS (Overall survival)
Time frame: Up to 2 years after lymphodepletion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- 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. 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 1/2 study testing ThisCART19A, Fludarabine and Cyclophosphamide in people with Refractory or Relapsed B Cell Lymphoma, run by Chongqing University 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 17 inclusion and 9 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 20 Mar 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao Liu, MD (13228684685, liuyao77@cqu.edu.cn), 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 r/r B cell Lymphoma (time frame: 28 days). The study lists 5 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 20 Mar 2023.