B Cell MalignancyPhase 1NCT04601181
Safety and Efficacy of ThisCART22 in Patients With Refractory or Relapsed B Cell Malignancies
A Phase 1 study testing ThisCART22 cells injection in people with B Cell Malignancy, run by Fundamenta Therapeutics, Ltd. at 1 site in China.
Trial summary
This is a single-center, nonrandomized, open-label, study to evaluate the safety and clinical activity of allogeneic CAR-T targeting CD22 in patients with refractory or relapsed CD22-positive B cell malignancies Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- B Cell Malignancy
- What is being tested?
- ThisCART22 cells injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2020to 15 Oct 2023
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who volunteered to participate in the research and signed a written informed consent;
- The informed consent was signed between the ages of 3-70, regardless of gender or race;
- CD22 positive hematologic malignancies with no alternative treatment options deemed by investigator. including those who are not eligible for allogeneic stem cell transplantation (SCT) due to the following reasons： 3.1 age； 3.2 Concurrent disease； 3.3 Other contraindications, such as contraindications to total body irradiation (TBI) (TBI is one of the important treatment measures before allogeneic stem cell transplantation of ALL)； 3.4 Lack of suitable donors； 3.5 Patients with relapse after CD19-CAR T treatment；
- Estimated life expectancy > 12 weeks deemed by investigator
- Recurrence after any stem cell transplantation (regardless of previous treatment regimen);
- Patients who relapse after previous allogeneic SCT (myeloablative or non-myeloablative) and meet all the following entry criteria:
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- 6.1 No active GVHD and no immunosuppression is required； 6.2 Transplant for more than 4 months；
- Serum creatinine ≤1.6 mg/dl and/or BUN ≤ 1.5 mg/dl；
- Serum ALT/ AST < 5 upper limit of normal (ULN)；
- Measurable or detectable disease at time of enrollment，include minimal residual disease (MRD) detected by immunotyping, cytogenetics or PCR.
- Cardiac ejection fraction ≥ 40%.
- Eastern cooperative oncology group (ECOG) performance status of ≤ 2.
- Female subjects with fertility have a negative pregnancy test result within 48 hours before the infusion and are not breast-feeding; all subjects with fertility potential before being enrolled in the study and throughout the study period until the last infusion Within 3 months, take adequate contraceptive measures.
Who cannot join
- Pregnant or lactating women;
- Participated in another clinical trial during the first 4 weeks of the enrolled study or intended to participate in another clinical trial throughout the study period;
- Have been treated with any gene product;
- Uncontrolled infection;
- History of HIV infection;
- Active hepatitis B virus or hepatitis C virus infection;
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- Systemic steroid therapy may be required for cell infusion or collection, or there may be conditions that the investigator considers may require steroid therapy during blood collection or infusion.Corticosteroids for disease treatment are permitted, and inhaled steroids or hydrocortisone physiologic replacement therapy for patients with adrenocortical dysfunction is permitted beyond the time of cell collection or infusion;
- Patients with grade 2-4 GVHD, or deemed need to manage by investigator;
- The presence of GVHD under treatment;.
- Patients with active CNS involvement by malignancy;
- Patients combine with other disease cause neutrophil count (ANC) <750/uL or PLT< 50,000/uL
- The researchers considered the subjects unsuitable for this clinical trial for various reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, 230001
Xingbing Wang, M.D., +8613856007984, wangxingbing@ustc.edu.cn
Jun Li, Ph.D., +8618662604088, jli@ctigen.com
About this study
Official title: A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD22 in Patients With Refractory or Relapsed B Cell Malignancies
This is a single-center, nonrandomized, open-label, study to evaluate the safety and clinical activity of allogeneic CAR-T targeting CD22 in patients with refractory or relapsed CD22-positive B cell malignancies
Read the detailed description
The patients will receive infusion of ThisCART22 cells from health donor ,to evaluate the safety and efficacy of ThisCART22 Cells in patients with refractory or relapsed CD22-positive B cell malignancies.
In this study, the dose range is 0.2-60 x10^6 cells per kg body weight (no more than 3.0 x 10^9 in total).
- Conditions
- B Cell Malignancy
- Being tested
- ThisCART22 cells injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThisCART22 cells injectionBiological
Assigned Interventions Biological/Vaccine: ThisCART22 cells 0.2-60 x 10^6 CAR-T cells per kg body weight.
Intervention study
| Study group | Role | What they receive |
|---|---|---|
| ThisCART22 cells injection | Experimental | In this arm，allogeneic anti-CD22 CAR T Cells(ThisCART22 cells) is used to treat patients with refractory or relapsed CD22 positive B cell malignancies. Receives: Biological: ThisCART22 cells injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of AE or SAE of CART cell infusion in relation to the study drug at grade ≥3 (refer to CTCAE version 4.03);
Measured: From infusion to week 12
ORR (sum of CR and CRi) after infusion.
Measured: From infusion to week 12
Secondary outcomes (2)
The survival time of CAR-T-22 cells in vivo;
Measured: From infusion to month 12
ORR at week 4, 8, and 24 after infusion (ORR4, ORR8, ORR24).
Measured: At week 4, 8, and 24 after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start23 Oct 2020
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell MalignancyStudies 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
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundamenta Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
- Responsible party
- Sponsor
- Investigators
- Xingbing Wang, M.D., Principal investigator, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601181
- Sponsor's protocol ID
- ThisCART22
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2020
- Last updated
- 1 Dec 2020
- 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 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD22 in Patients With Refractory or Relapsed B Cell Malignancies
- ClinicalTrials.gov ID
- NCT04601181
- Acronym / sponsor ID
- ThisCART22
- Conditions
- B Cell Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundamenta Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 23 Oct 2020 (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-center, nonrandomized, open-label, study to evaluate the safety and clinical activity of allogeneic CAR-T targeting CD22 in patients with refractory or relapsed CD22-positive B cell malignancies
Detailed description
The patients will receive infusion of ThisCART22 cells from health donor ,to evaluate the safety and efficacy of ThisCART22 Cells in patients with refractory or relapsed CD22-positive B cell malignancies.
In this study, the dose range is 0.2-60 x10^6 cells per kg body weight (no more than 3.0 x 10^9 in total).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| ThisCART22 cells injection | Experimental | Biological: ThisCART22 cells injectionIn this arm，allogeneic anti-CD22 CAR T Cells(ThisCART22 cells) is used to treat patients with refractory or relapsed CD22 positive B cell malignancies. |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects who volunteered to participate in the research and signed a written informed consent;
- The informed consent was signed between the ages of 3-70, regardless of gender or race;
- CD22 positive hematologic malignancies with no alternative treatment options deemed by investigator. including those who are not eligible for allogeneic stem cell transplantation (SCT) due to the following reasons： 3.1 age； 3.2 Concurrent disease； 3.3 Other contraindications, such as contraindications to total body irradiation (TBI) (TBI is one of the important treatment measures before allogeneic stem cell transplantation of ALL)； 3.4 Lack of suitable donors； 3.5 Patients with relapse after CD19-CAR T treatment；
- Estimated life expectancy > 12 weeks deemed by investigator
- Recurrence after any stem cell transplantation (regardless of previous treatment regimen);
Key exclusion criteria (12 listed)
- Pregnant or lactating women;
- Participated in another clinical trial during the first 4 weeks of the enrolled study or intended to participate in another clinical trial throughout the study period;
- Have been treated with any gene product;
- Uncontrolled infection;
- History of HIV infection;
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 |
|---|---|---|
| ThisCART22 cells injectionAssigned Interventions Biological/Vaccine: ThisCART22 cells 0.2-60 x 10^6 CAR-T cells per kg body weight. Intervention study | Biological | ThisCART22 cells injection |
Primary outcome
The incidence of AE or SAE of CART cell infusion in relation to the study drug at grade ≥3 (refer to CTCAE version 4.03);
Time frame: From infusion to week 12
ORR (sum of CR and CRi) after infusion.
Time frame: From infusion to week 12
2 secondary outcomes
The survival time of CAR-T-22 cells in vivo;
Time frame: From infusion to month 12
ORR at week 4, 8, and 24 after infusion (ORR4, ORR8, ORR24).
Time frame: At week 4, 8, and 24 after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- 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.
Xingbing Wang, M.D. principal investigator
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
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 ThisCART22 cells injection in people with B Cell Malignancy, run by Fundamenta Therapeutics, Ltd. 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 13 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 1 Dec 2020. 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 Xingbing Wang, M.D. (+8613856007984, wangxingbing@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of AE or SAE of CART cell infusion in relation to the study drug at grade ≥3 (refer to CTCAE version 4.03); (time frame: From infusion to week 12). The study lists 2 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 1 Dec 2020.