Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited, r/r B-NHLPhase 1NCT05535673
Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With Refractory or Relapsed B Cell Lymphoma
A Phase 1 study testing ThisCART19A in people with Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited, r/r B-NHL, run by Zhengzhou University.
Trial summary
This is a single dose escalation study to evaluate the safety, efficacy and pharmacokinetics of ThisCART19A (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited, r/r B-NHL
- What is being tested?
- ThisCART19A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2022to 1 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 years old;
- Histologically confirmed diagnosis per WHO Classification Criteria for Lymphocytic Tumors 2017, including follicular lymphoma (FL), marginal zone lymphoma (MZL, including SMZL, NMZL and extranodal MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), etc;
- Relapsed or refractory B-cell NHL.
- Adequate treatment :
- Follicular lymphoma should be treated with at least two prior treatment including alkylating agents and anti-CD20 mAbs;
- Marginal zone lymphoma should be treated with at least two prior treatment including anti-CD20 mAbs;
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- mantle cell lymphoma should be treated with a first-line therapy including anthracyclines/bendamoxetine+anti-CD20 mAbs;
- Diffuse large B lymphoma, not otherwise specified (DLBCL, NOS), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double/triple hit lymphoma, DHL/THL), diffuse large B-cell lymphoma (DLBCL) transformed from follicular lymphoma (FL), histological grade 3b follicular lymphoma. relapsed or primary refractory lymphoma within 12 months after first-line treatment, first-line therapy including anthracycline and anti-CD20 mAbs.
- Failing to autologous CAR-T therapy.
- Estimated life expectancy > 12 weeks deemed by investigator；
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- At least one measurable lesion, with any nodal lesion > 15mm in the longest diameter and any extranodal lesion > 10mm in the longest diameter.
- Adequate bone marrow, renal, hepatic, pulmonary and cardiac function;
- Should be confirmed Cluster of differentiation(CD)19 positive by biopsy for the patient who received target CD19 therapy before.
Who cannot join
- Allergic to preconditioning measures.
- HP-positive MALT;
- Patients with risks of deep gastrointestinal ulcers, perforation or gastrointestinal bleeding
- 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.
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- Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment.
- Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening.
- 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 ≥7.5 cm).
- Receive allogeneic hematopoietic stem cell transplantation less than 100 days.
- Vaccinated with influenza vaccine within 2 weeks prior to lymphodepleting chemotherapy (Severe Acute Respiratory Syndrome-Corona virus disease 19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) .
- Patients who are receiving Graft versus host disease Hepatitis(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
No sites are listed yet.
About this study
Official title: A Single Dose-escalation 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 single dose escalation study to evaluate the safety, efficacy and pharmacokinetics of ThisCART19A (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell Lymphoma.
Read the detailed description
This is a single-center, nonrandomized, open-label, dose-escalation study to evaluate the safety, efficacy and pharmacokinetics of ThisCART19A in patients with refractory or relapsed CD19 positive B cell Lymphoma, such as Diffuse large B-cell lymphoma (DLBCL) , follicular lymphoma and etc.
- Being tested
- ThisCART19A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThisCART19ADrug
In this study, allogeneic anti-CD19 CAR-T cell (ThisCART19A) injection is used to treat patients with refractory or relapsed CD19 positive B cell Lymphoma.
| Study group | Role | What they receive |
|---|---|---|
| ThisCART19A cell injection | Experimental | In this study, allogeneic anti-CD19 CART cell (This CART19A) injection is used to treat patients with refractory or relapsed CD19 positive B cell Lymphoma. Receives: Drug: ThisCART19A |
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 NHL 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
The incidence of all grade TEAEs and ≥3 grade TEAEs during dose escalation stage
Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs
Measured: Up to 2 years after ThisCART19A infusion
Objective Response Rate in patient with NHL during dose expansion stage
the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment
Measured: 12 months
Secondary outcomes (7)
Analysis the severity and Incidence of Adverse Events in each dose level during dose escalation and dose expansion stage
Including more than or equal to grade 3 adverse events graded according to the NCI CTCAE v5.0, or the adverse events with special attention
Measured: 3 months
Analysis the change characteristics of CART cell number and copy number during dose escalation and expansion stages
Track CAR T cells expansion in patients after infusion
Measured: 6 months
the change characteristics of immune effect cells number during dose escalation and expansion stages
Analysis the effect cells (such as CD19+ B cells、T cells、NK cells)
Measured: 3 months
Analysis the change characteristics of cytokines during dose escalation and expansion stages (IL-1β/IL-2/IL-4/IL-5/IL-6/IL-8/IL-10/IL-12p70/IL-17A/IL-17F/IL-22/TNF-α/TNF-β)
cytokines including IL-1β/IL-2/IL-4/IL-5/IL-6/IL-8/IL-10/IL-12p70/IL-17A/IL-17F/IL-22/TNF-α/TNF-β
Measured: 3 months
Duration of response (DOR) during dose escalation stage and expansion stage
The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR)
Measured: 12 months
Progress-free survival (PFS) during dose escalation stage and expansion stage
Progress-free survival (PFS) is defined as time from the first CAR-T cell infusion date to first documentation of PD, or death from any cause.
Measured: 12 months
OS(overall survival) during dose escalation stage and expansion stage
Overall survival (OS) is defined as the time from the date of lymphodepletion until death from any cause.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start2 Sep 2022 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 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 Edited, r/r B-NHLStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Collaborators
- Fundamenta Therapeutics, Ltd.
- Responsible party
- Principal investigator, Mingzhi Zhang, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535673
- Sponsor's protocol ID
- FT400-010
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2022
- Last updated
- 10 Sep 2022
- 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 Sep 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, Efficacy and Pharmacokinetics of Allogeneic CAR-T Targeting CD19 in Patients With Refractory or Relapsed B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05535673
- Acronym / sponsor ID
- FT400-010
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Fundamenta Therapeutics, Ltd.
- Study start
- 2 Sep 2022 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 10 Sep 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 single dose escalation study to evaluate the safety, efficacy and pharmacokinetics of ThisCART19A (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell Lymphoma.
Detailed description
This is a single-center, nonrandomized, open-label, dose-escalation study to evaluate the safety, efficacy and pharmacokinetics of ThisCART19A in patients with refractory or relapsed CD19 positive B cell Lymphoma, such as Diffuse large B-cell lymphoma (DLBCL) , follicular lymphoma and etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ThisCART19A cell injection | Experimental | Drug: ThisCART19AIn this study, allogeneic anti-CD19 CART cell (This CART19A) injection is used to treat patients with refractory or relapsed CD19 positive B cell Lymphoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female aged ≥ 18 years old;
- Histologically confirmed diagnosis per WHO Classification Criteria for Lymphocytic Tumors 2017, including follicular lymphoma (FL), marginal zone lymphoma (MZL, including SMZL, NMZL and extranodal MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), etc;
- Relapsed or refractory B-cell NHL.
- Adequate treatment :
- Failing to autologous CAR-T therapy.
Key exclusion criteria (14 listed)
- Allergic to preconditioning measures.
- HP-positive MALT;
- Patients with risks of deep gastrointestinal ulcers, perforation or gastrointestinal bleeding
- 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.
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 |
|---|---|---|
| ThisCART19AIn this study, allogeneic anti-CD19 CAR-T cell (ThisCART19A) injection is used to treat patients with refractory or relapsed CD19 positive B cell Lymphoma. | Drug | ThisCART19A cell injection |
Primary outcome
Dose limited toxicity(DLT) observation in patient with NHL 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.
The incidence of all grade TEAEs and ≥3 grade TEAEs during dose escalation stage
Time frame: Up to 2 years after ThisCART19A infusion
Incidence of treatment-emergent adverse events (TEAEs) and ≥3 grade TEAEs
Objective Response Rate in patient with NHL during dose expansion stage
Time frame: 12 months
the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as best response to treatment
7 secondary outcomes
Analysis the severity and Incidence of Adverse Events in each dose level during dose escalation and dose expansion stage
Time frame: 3 months
Analysis the change characteristics of CART cell number and copy number during dose escalation and expansion stages
Time frame: 6 months
the change characteristics of immune effect cells number during dose escalation and expansion stages
Time frame: 3 months
Analysis the change characteristics of cytokines during dose escalation and expansion stages (IL-1β/IL-2/IL-4/IL-5/IL-6/IL-8/IL-10/IL-12p70/IL-17A/IL-17F/IL-22/TNF-α/TNF-β)
Time frame: 3 months
Duration of response (DOR) during dose escalation stage and expansion stage
Time frame: 12 months
Progress-free survival (PFS) during dose escalation stage and expansion stage
Time frame: 12 months
OS(overall survival) during dose escalation stage and expansion stage
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ThisCART19A in people with Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited, r/r B-NHL, run by Zhengzhou University.
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 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 10 Sep 2022. 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 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 Jun Li, Ph.D. (18662604088 ext. +86, jli@ctigen.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 NHL 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 10 Sep 2022.