AIDS Related Lymphoma and LympholeukemiaPhase 1NCT05340829
Evaluate the Safety and Effect of ThisCART19A in Patients With AIDS Related B Cell Lymphoma/Lympholeukemia
A Phase 1 study testing ThisCART19A in people with AIDS Related Lymphoma and Lympholeukemia, run by He Huang at 1 site in China.
Trial summary
This is an open label, phase I study to assess the safety and efficacy of ThisCART19A in patients with AIDS related B cell lymphoma/lympholeukemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AIDS Related Lymphoma and Lympholeukemia
- What is being tested?
- ThisCART19A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2022to 30 Apr 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65.
- Patients with AIDS-associated B-cell lymphoma/leukemia, including but not limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma tranferring to DLBCL, mantle cell lymphoma (MCL), follicular lymphoma 3B (FL-3B), original Mediastinal (thymus) large B-cell lymphoma, high-grade B-cell lymphoma and leukemia.
- At least received first line treatment.
- Had available evaluation lesion.
- ECOG(Eastern Cooperative Oncology Group) ≤ 1 or Karnofsky ≥ 60%.
- Had good organic function within 4 weeks before enrollment: 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; Serum creatinine≤1.5×ULN or creatinine clearance>30 mL/min/1.73 m2.
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- Confirmed Cluster of differentiation(CD)19 positive by biopsy for the patients who received CD19 target therapy before.
- Confirmed Human immunodeficiency virus(HIV)-1 infection.
- HIV virus loading < 200 copy/ml within 4 weeks before screening.
- CD4+T cell counts >50 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.
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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, 1 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310003
He Huang, Doctor, 86-13605714822, hehuangyu@126.com
About this study
Official title: To Evaluate the Safety, Efficacy, Pharmacokinetics of ThisCART19A in Patients With AIDS Related B Cell Lymphoma/Lympholeukemia
This is an open label, phase I study to assess the safety and efficacy of ThisCART19A in patients with AIDS related B cell lymphoma/lympholeukemia.
- Conditions
- AIDS Related Lymphoma and Lympholeukemia
- Being tested
- ThisCART19A
- Medical subject headings
- Lymphoma, AIDS-Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThisCART19ABiological
ThisCART19A is a new type CAR-T cells therapy for patients with lymphoma and lympholeukemia
| Study group | Role | What they receive |
|---|---|---|
| ThisCART19A 2×10^6 cells/kg for dose level 1 | Experimental | Patients will receive 2×10^6 cells/kg of ThisCART19A Receives: Biological: ThisCART19A |
| ThisCART19A 3×10^6 cells/kg as dose level 2 | Experimental | Patients will receive 3×10^6 cells/kg of ThisCART19A Receives: Biological: ThisCART19A |
| Patients will receive 4×10^6 cells/kg as dose level 3 | Experimental | Patients will receive 4×10^6 cells/kg of ThisCART19A Receives: Biological: ThisCART19A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
Measured: 28 days
Secondary outcomes (5)
Objective Response rate in patients with AIDS related lymphoma
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
The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion
Track CAR-T cells expansion in patients after infusion
Measured: 6 months
Analysis the change characteristics of cytokines and immune effect cells number in patients after infusion
Analysis the effect cells and cytokines in patients after infusion
Measured: 3 months
Analysis the severity and Incidence of Adverse Events in each dose level
Including more than or equal to grade 3 adverse events graded according to the NCI CTCAE v5.0, the adverse events with special consideration
Measured: 12 months
Analysis the immunogenicity(Anti-therapeutic antibody and neutralizing antibody) of CAR-T cells in patients after infusion
Analysis the Anti-therapeutic antibody and neutralizing antibody level after infusion
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 posted22 Apr 2022
- Study start18 Mar 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS Related Lymphoma and LympholeukemiaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, He Huang, Zhejiang University
- Investigators
- He Huang, Doctor, Principal investigator, First hospital affiliated Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340829
- Sponsor's protocol ID
- FT400-006
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety, Efficacy, Pharmacokinetics of ThisCART19A in Patients With AIDS Related B Cell Lymphoma/Lympholeukemia
- ClinicalTrials.gov ID
- NCT05340829
- Acronym / sponsor ID
- FT400-006
- Conditions
- AIDS Related Lymphoma and Lympholeukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- He HuangUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 22 Apr 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 an open label, phase I study to assess the safety and efficacy of ThisCART19A in patients with AIDS related B cell lymphoma/lympholeukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ThisCART19A 2×10^6 cells/kg for dose level 1 | Experimental | Biological: ThisCART19APatients will receive 2×10^6 cells/kg of ThisCART19A |
| ThisCART19A 3×10^6 cells/kg as dose level 2 | Experimental | Biological: ThisCART19APatients will receive 3×10^6 cells/kg of ThisCART19A |
| Patients will receive 4×10^6 cells/kg as dose level 3 | Experimental | Biological: ThisCART19APatients will receive 4×10^6 cells/kg of ThisCART19A |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-65.
- Patients with AIDS-associated B-cell lymphoma/leukemia, including but not limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma tranferring to DLBCL, mantle cell lymphoma (MCL), follicular lymphoma 3B (FL-3B), original Mediastinal (thymus) large B-cell lymphoma, high-grade B-cell lymphoma and leukemia.
- At least received first line treatment.
- Had available evaluation lesion.
- ECOG(Eastern Cooperative Oncology Group) ≤ 1 or Karnofsky ≥ 60%.
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 |
|---|---|---|
| ThisCART19AThisCART19A is a new type CAR-T cells therapy for patients with lymphoma and lympholeukemia | Biological | Patients will receive 4×10^6 cells/kg as dose level 3, ThisCART19A 2×10^6 cells/kg for dose level 1, ThisCART19A 3×10^6 cells/kg as dose level 2 |
Primary outcome
Dose limited toxicity(DLT) observation and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level
Time frame: 28 days
DLT is defined as the incidence of severe adverse events related to ThisCART19A more than 33% in each dose level.
5 secondary outcomes
Objective Response rate in patients with AIDS related lymphoma
Time frame: 12 months
The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion
Time frame: 6 months
Analysis the change characteristics of cytokines and immune effect cells number in patients after infusion
Time frame: 3 months
Analysis the severity and Incidence of Adverse Events in each dose level
Time frame: 12 months
Analysis the immunogenicity(Anti-therapeutic antibody and neutralizing antibody) of CAR-T cells in patients after infusion
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 22 Apr 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.
He Huang, Doctor principal investigator
First hospital affiliated Zhejiang University
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 in people with AIDS Related Lymphoma and Lympholeukemia, run by He Huang 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 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 22 Apr 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 Ming Ming Zhang, Doctor (13656674208, mingmingzhang@zju.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 and the incidence of treatment-emergent adverse events(TEAE) which more than or equal to grade 3 in each dose level (time frame: 28 days). 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 22 Apr 2022.