Acute Lymphoblastic Leukemia, in RelapsePhase 1NCT06445803
CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
A Phase 1 study testing KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells） in people with Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia With Failed Remission, run by Rong Tao at 2 sites in China.
Trial summary
This study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia With Failed Remission, B-cell Lymphoma Refractory
- What is being tested?
- KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesChina
- Study dates
- 31 May 2024to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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,≥18 years old;
- Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions):
- (B-NHL)
- Second or greater relapse (CD20 regimens must be included) OR
- Refractory to first-line chemotherapy or relapse within 1 year OR
- Relapse within 1 year of auto-HSCT.
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- With measurable or evaluable lesions（Dose expansion cohort） (B-ALL)
- Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR/CRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs.
- ECOG 0~2
- Estimated survival time ≥ 12 weeks;
- Main tissues and organs function well.
Who cannot join
- Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg/d or equivalent) within 72 h
- Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
- Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy；
- active bleeding, or venous thromboembolic event
- Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that result in end-organ damage or require systemic application of immunosuppressive drugs
- Central nervous system (CNS) disease or symptoms of CNS involvement
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- Pregnant or nursing (lactating) women
- Presence of Grade 2 or above non-hematologic toxicity , alopecia and grade 2 neuropathy excluded
- Any Iinappropriate conditions in the opinion of the PI .
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Nanchang University;
Nanchang, Jiangxi, 360000
Fei Li, MD, 13970038386, lifeigcp@2022@163.com
Fei Li, MD
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Rong Tao, MD, 8621-64175590, rtao@shca.org.cn
Wenhao Zhang, MD, 8621-64175590, zwhl98@foxmail.com
About this study
Official title: A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19/CD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
This study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
Read the detailed description
Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 KQ-2002 CAR T cell infusion. The lymphodepleting chemotherapy is administered over 3 days IV to prepare the body for the CAR T cells. The CAR-T cells are infused between 2-7 days after the last dose of chemotherapy. Patients will be followed for two years after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.
- Conditions
- Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia With Failed Remission, B-cell Lymphoma Refractory, B-cell Lymphoma Recurrent
- Being tested
- KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）
- Keywords
- CAR-T therapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）Biological
CD19/CD22 cells will be infused on Day1 after induction chemotherapy regimen.
Lymphodepleting chemotherapy:3 days of IV chemotherapy with fludarabine and cyclophosphamide.
Fludarabine 30 mg/m2/day IV x 4 days (days -5 through -3) Cyclophosphamide 500 mg/m2/day IV x 2 days (days -5 and-3)
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | CD19/CD22-CAR-transduced T cells at escalating doses (0.5~5.0 ×10^6 cells/kg) Receives: Biological: KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells） |
| Dose expansion | Experimental | CD19/CD22-CAR-transduced T cells at MTD or highest dose administered Receives: Biological: KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-limiting toxicity
Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to 28 days
Incidence and severity of adverse events
Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to 15 years
Secondary outcomes (5)
Overall response rate
Proportion of patients achieving a response
Measured: up to 15 years
Progression free survival
Preparative regimen until the documentation of disease progression or death due to any cause, whichever occurs first.
Measured: up to 15 years
Overall survival
Overall survival (OS) will be determined as the time from the start of the preparative regimen until death
Measured: up to 15 years
MRD negative response rates（ Acute Lymphoblastic Leukemia ）
MRD status post infusion，MRD will be performed utilizing flow cytometry or PCR.
Measured: up to 15 years
Persistence of CD19/CD22 CAR-T cells blood, bone marrow
pk properties of CD19/CD22 CAR-T
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start31 May 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, in RelapseStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rong Tao
- Sponsor type
- University, hospital or other
- Collaborators
- Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
- Responsible party
- Sponsor-investigator, Rong Tao, Fudan University
- Investigators
- Rong Tao, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445803
- Sponsor's protocol ID
- KQ-2002-XC001
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19/CD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT06445803
- Acronym / sponsor ID
- KQ-2002-XC001
- Conditions
- Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia With Failed Remission, B-cell Lymphoma Refractory, B-cell Lymphoma Recurrent
- Keywords
- CAR-T therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Rong TaoUniversity, hospital or other
- Collaborators
- Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
- Study start
- 31 May 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jun 2024 (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 study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
Detailed description
Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 KQ-2002 CAR T cell infusion. The lymphodepleting chemotherapy is administered over 3 days IV to prepare the body for the CAR T cells. The CAR-T cells are infused between 2-7 days after the last dose of chemotherapy. Patients will be followed for two years after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Biological: KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）CD19/CD22-CAR-transduced T cells at escalating doses (0.5~5.0 ×10^6 cells/kg) |
| Dose expansion | Experimental | Biological: KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）CD19/CD22-CAR-transduced T cells at MTD or highest dose administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female,≥18 years old;
- Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions):
- (B-NHL)
- Second or greater relapse (CD20 regimens must be included) OR
- Refractory to first-line chemotherapy or relapse within 1 year OR
Key exclusion criteria (9 listed)
- Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg/d or equivalent) within 72 h
- Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
- Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy；
- active bleeding, or venous thromboembolic event
- Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that result in end-organ damage or require systemic application of immunosuppressive drugs
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 |
|---|---|---|
| KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）CD19/CD22 cells will be infused on Day1 after induction chemotherapy regimen. Lymphodepleting chemotherapy:3 days of IV chemotherapy with fludarabine and cyclophosphamide. Fludarabine 30 mg/m2/day IV x 4 days (days -5 through -3) Cyclophosphamide 500 mg/m2/day IV x 2 days (days -5 and-3) | Biological | Dose escalation, Dose expansion |
Primary outcome
Incidence of Dose-limiting toxicity
Time frame: Up to 28 days
Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Incidence and severity of adverse events
Time frame: Up to 15 years
Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
5 secondary outcomes
Overall response rate
Time frame: up to 15 years
Progression free survival
Time frame: up to 15 years
Overall survival
Time frame: up to 15 years
MRD negative response rates（ Acute Lymphoblastic Leukemia ）
Time frame: up to 15 years
Persistence of CD19/CD22 CAR-T cells blood, bone marrow
Time frame: up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- 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.
Rong Tao, MD principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells） in people with Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia With Failed Remission, run by Rong Tao at 2 sites 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 11 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: looking for participants now, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weijing Zhang (021-64175590 ext. 88503, JJYIN555@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-limiting toxicity (time frame: Up to 28 days). 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 6 Jun 2024.