Acute Lymphoblastic LeukemiaPhase 1NCT02443831
CARPALL: Immunotherapy With CD19+CD22 CAR T-cells for CD19+ and CD22+ Acute Lymphoblastic Leukaemia
A Phase 1 study testing Leukapheresis, Total Body Irradiation (TBI) and Lymphodepletion with Fludarabine in people with Acute Lymphoblastic Leukemia, run by University College, London at 3 sites in United Kingdom.
Trial summary
This study aims to evaluate the safety, efficacy and duration of response of CD19+CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia Read more about this study
- Who is it for?
- Ages Up to 24 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Leukapheresis, Total Body Irradiation (TBI) and Lymphodepletion with Fludarabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Apr 2016to 31 Dec 2041
- 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 Up to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and young adults (age 24 years or younger) with high risk/relapsed CD19+ and CD22+ acute lymphoblastic leukaemia with:
- Resistant disease (>5% blasts) at end of ALLTogether-1 protocol or equivalent induction
- ALL with persisting high level MRD at 2nd time point of frontline national protocol (currently MRD >10-4 at week 9 ALLTogether-1 Protocol or equivalent).
- High risk infant ALL (age < 6 months at diagnosis with MLL gene rearrangement and either presenting white cell count > 300 x 10^9/L or poor steroid early response (i.e. circulating blast count >1x10^9/L following 7 day steroid pre-phase of induction as per national guidelines or equivalent)
- Any patient with t(17,19) TCF3-HLF rearrangement
- High risk 1st relapse (defined as very early (relapse within 18 months of diagnosis) and early relapses (any patient relapsing on therapy or within 6 months of completing treatment) and any relapse with high risk genetics, namely (KMT2A (MLL) rearrangements, low hypodiploidy/near haploidy, t(17;19)(q22;p13)/TCF3-HLF, iAMP21 and t(1;19)(q21;p13)/TCF3- PBX1, t(9;22)(34.1 q11.2)/BCR-ABL1
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- Any on therapy relapse in patients age 16-24
- Any relapse of infant ALL
- ALL post ≥ 2nd relapse
- Any refractory relapse of ALL (defined as > 1% blasts by flow cytometry after a at least 1 cycle of standard chemotherapy)
- ALL with MRD >10-4 prior to planned stem cell transplant
- Any relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant
- Any relapse of ALL after stem cell transplant as long as planned time of CD19+CD22CAR T cell infusion is > 4 months post-transplant
- Early (defined as < 6 months post-infusion) loss of B cell aplasia or any CD19+CD22+ relapse following CD19CAR T cell therapy with Tisagenlecleucel
- Note patients with isolated CNS relapse meeting one or more of the criteria above are eligible for the study
- Agreement to have a pregnancy test, use adequate contraception (if applicable)
- Written informed consent
Who cannot join
- Active Hepatitis B, C or HIV infection
- Oxygen saturation ≤ 90% on air
- Bilirubin > 3 x upper limit of normal
- Creatinine > 3 x upper limit of normal
- Women who are pregnant or breastfeeding
- Stem Cell Transplant patients only: active significant (overall Grade ≥ II, Seattle criteria) acute GVHD or moderate/ severe chronic GVHD (NIH consensus criteria) requiring systemic steroids.
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- Inability to tolerate leucapheresis
- Karnofsky (age ≥ 10 years) or Lansky (age < 10) score ≤ 50%
- Pre-existing significant neurological disorder (other than CNS involvement of underlying haematological malignancy)
- CD19 negative or CD22 negative disease
- Severe intercurrent infection at the time of scheduled CD19+CD22 CAR T-cell infusion
- Requirement for supplementary oxygen or active pulmonary infiltrates at the time of scheduled CD19+CD22 CAR T-cell infusion
- Allogeneic transplant recipients with active significant acute GVHD overall grade ≥II or moderate/severe chronic GVHD requiring systemic steroids at the time of scheduled CD19+CD22 CAR T-cell infusion. Note: Such patients will be excluded until the patient is GVHD free and off steroids
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Recruiting
Great Ormond Street Hospital
London
Prof. Persis Amrolia
- Recruiting
University College Hospital
London
Dr Rachael Hough
- Recruiting
Manchester Royal Children's Hospital
Manchester
Dr Denise Bonney
About this study
Official title: Immunotherapy With CD19+CD22 CAR Redirected T-cells for High Risk/Relapsed Paediatric CD19+ and CD22+ Acute Lymphoblastic Leukaemia
This study aims to evaluate the safety, efficacy and duration of response of CD19+CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia
Read the detailed description
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19+CD22 Chimeric Antigen Receptor (CAR) T-cells (CD19+CD22 CAR T-cells) in children and young adults (age <24 years) with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19+CD22 CAR T-cells. Patients will receive the CD19+CD22CAR T-cells following lymphodepleting chemotherapy and total body irradiation. The study will evaluate the safety, efficacy and duration of response of the CD19+CD22 CAR T-cells in children with high risk relapsed CD19+ and CD22+ acute lymphoblastic leukaemia.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Leukapheresis, Total Body Irradiation (TBI), Lymphodepletion with Fludarabine, Lymphodepletion with Cyclophosphamide, CD19+CD22 CAR T-cells
- Keywords
- high risk relapsed CD19+ and CD22+ acute lymphoblastic leukaemia
- 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.
LeukapheresisProcedure or surgery
Patients will undergo an unstimulated leukapheresis to isolate the required immune cells to produce the CD19+CD22 CAR T-cells
Total Body Irradiation (TBI)Radiation
Participants will receive low-dose total body irradiation delivered as a single fraction on day -7 prior to CD19+CD22CAR T-cell infusion.
Lymphodepletion with FludarabineDrug
Patients will receive lymphodepleting chemotherapy with iv fludarabine on days -6 to -3 prior to CD19+CD22CAR T-cell infusion.
Lymphodepletion with CyclophosphamideDrug
Patients will receive lymphodepleting chemotherapy with iv cyclophosphamide on days -6 to -5 prior to CD19+CD22CAR T-cell infusion.
CD19+CD22 CAR T-cellsBiological
1 dose of CD19+CD22 CAR T-cells given as an intravenous injection through a Hickman line or PICC line (peripherally inserted central catheter) on day 0.
| Study group | Role | What they receive |
|---|---|---|
| CD19+CD22 CAR T-cells | Experimental | Patients meeting the eligibility criteria will have leukapheresis to isolate the blood immune cells used to manufacture the CD19+CD22CAR T-cells. Patients will receive lymphodepletion with low dose total body irradiation, fludarabine and cyclophosphamide prior to infusion of the CD19+CD22CAR T-cells. Receives: Procedure: Leukapheresis; Radiation: Total Body Irradiation (TBI); Drug: Lymphodepletion with Fludarabine; Drug: Lymphodepletion with Cyclophosphamide; Biological: CD19+CD22 CAR T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of unacceptable toxicity following CD19+CD22 CAR T-cell infusion
The incidence of unacceptable toxicity occurring within 28 days of CD19+CD22CAR T-cell infusion.
Measured: 28 days
Molecular remission
Efficacy will be assessed by determining Minimal Residual Disease in the bone marrow aspirate using immunoglobulin heavy chain (IgH) quantitative polymerase chain reaction (qPCR) and/or Next Generation Sequencing in all patients. The proportion of patients achieving molecular remission at 28 days post CD19+CD22CAR T-cell infusion will be determined.
Measured: 28 days
Secondary outcomes (10)
Feasibility of Generation of CD19+CD22 CAR T-cells
Evaluated by the number of therapeutic products generated.
Measured: Day 28
Molecular Remission
Efficacy will be assessed by determining Minimal Residual Disease in the bone marrow aspirate using immunoglobulin heavy chain (IgH) quantitative polymerase chain reaction (qPCR) and/or Next Generation Sequencing in all patients. The proportion of patients achieving molecular remission at 3 months post CD19+CD22CAR T-cell infusion will be determined.
Measured: 3 months
Long-Term Molecular Remission
Number of patients in molecular remission without further therapy at 1 and 2 years
Measured: 2 years
Duration of Response
Duration of response is measured from the time of achieving molecular remission or flow MRD negativity until the disease relapse or death, whichever occurs first.
Measured: 15 years
Safety and Tolerability of the CAR T-cells
Incidence of adverse events and reactions (toxicity) to the CAR T-cells.
Measured: 15 years
Incidence of B Aplasia
Incidence of B aplasia
Measured: 2 years
Incidence of Hypogammaglobulinaemia
Incidence of hypogammaglobulinaemia
Measured: 2 years
Frequency of Circulating CD19+CD22 CAR T-cells
Persistence and frequency of circulating CD19+CD22CAR T-cells in the peripheral blood by flow cytometry and qPCR analyses.
Measured: 2 years
Relapse rate
Relapse rate
Measured: 2 years
Overall Survival (OS)
Overall Survival (OS) at 1 and 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Persis Amrolia, Study chair, UCL Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443831
- Sponsor's protocol ID
- UCL 14/0529
- Status last verified
- Feb 2026
- First submitted
- 29 Apr 2015
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ghorashian S, Lucchini G, Richardson R, Nguyen K, Terris C, Guvenel A, Oporto-Espuelas M, Yeung J, Pinner D, Chu J, Williams L, Ko KY, Walding C, Watts K, Inglott S, Thomas R, Connor C, Adams S, Gravett E, Gilmour K, Lal A, Kunaseelan S, Popova B, Lopes A, Ngai Y, Hackshaw A, Kokalaki E, Carulla MB, Mullanfiroze K, Lazareva A, Pavasovic V, Rao A, Bartram J, Vora A, Chiesa R, Silva J, Rao K, Bonney D, Wynn R, Pule M, Hough R, Amrolia PJ. CD19/CD22 targeting with cotransduced CAR T cells to prevent antigen-negative relapse after CAR T-cell therapy for B-cell ALL. Blood. 2024 Jan 11;143(2):118-123. doi: 10.1182/blood.2023020621.
PubMed 37647647Kokalaki E, Ma B, Ferrari M, Grothier T, Hazelton W, Manzoor S, Costu E, Taylor J, Bulek A, Srivastava S, Gannon I, Jha R, Gealy R, Stanczuk L, Rizou T, Robson M, El-Kholy M, Baldan V, Righi M, Sillibourne J, Thomas S, Onuoha S, Cordoba S, Pule M. Dual targeting of CD19 and CD22 against B-ALL using a novel high-sensitivity aCD22 CAR. Mol Ther. 2023 Jul 5;31(7):2089-2104. doi: 10.1016/j.ymthe.2023.03.020. Epub 2023 Mar 21.
PubMed 36945773Ghorashian S, Kramer AM, Onuoha S, Wright G, Bartram J, Richardson R, Albon SJ, Casanovas-Company J, Castro F, Popova B, Villanueva K, Yeung J, Vetharoy W, Guvenel A, Wawrzyniecka PA, Mekkaoui L, Cheung GW, Pinner D, Chu J, Lucchini G, Silva J, Ciocarlie O, Lazareva A, Inglott S, Gilmour KC, Ahsan G, Ferrari M, Manzoor S, Champion K, Brooks T, Lopes A, Hackshaw A, Farzaneh F, Chiesa R, Rao K, Bonney D, Samarasinghe S, Goulden N, Vora A, Veys P, Hough R, Wynn R, Pule MA, Amrolia PJ. Enhanced CAR T cell expansion and prolonged persistence in pediatric patients with ALL treated with a low-affinity CD19 CAR. Nat Med. 2019 Sep;25(9):1408-1414. doi: 10.1038/s41591-019-0549-5. Epub 2019 Sep 2.
PubMed 31477906
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy With CD19+CD22 CAR Redirected T-cells for High Risk/Relapsed Paediatric CD19+ and CD22+ Acute Lymphoblastic Leukaemia
- ClinicalTrials.gov ID
- NCT02443831
- Acronym / sponsor ID
- UCL 14/0529
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- high risk relapsed CD19+ and CD22+ acute lymphoblastic leukaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2041 (estimated)
- First posted
- 14 May 2015 (estimated)
- 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 aims to evaluate the safety, efficacy and duration of response of CD19+CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia
Detailed description
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19+CD22 Chimeric Antigen Receptor (CAR) T-cells (CD19+CD22 CAR T-cells) in children and young adults (age <24 years) with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19+CD22 CAR T-cells. Patients will receive the CD19+CD22CAR T-cells following lymphodepleting chemotherapy and total body irradiation. The study will evaluate the safety, efficacy and duration of response of the CD19+CD22 CAR T-cells in children with high risk relapsed CD19+ and CD22+ acute lymphoblastic leukaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19+CD22 CAR T-cells | Experimental | Procedure: Leukapheresis, Radiation: Total Body Irradiation (TBI), Drug: Lymphodepletion with Fludarabine, Drug: Lymphodepletion with Cyclophosphamide, Biological: CD19+CD22 CAR T-cellsPatients meeting the eligibility criteria will have leukapheresis to isolate the blood immune cells used to manufacture the CD19+CD22CAR T-cells. Patients will receive lymphodepletion with low dose total body irradiation, fludarabine and cyclophosphamide prior to infusion of the CD19+CD22CAR T-cells. |
Who may qualify
- Ages
- Up to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Children and young adults (age 24 years or younger) with high risk/relapsed CD19+ and CD22+ acute lymphoblastic leukaemia with:
- Note patients with isolated CNS relapse meeting one or more of the criteria above are eligible for the study
- Agreement to have a pregnancy test, use adequate contraception (if applicable)
- Written informed consent
Key exclusion criteria (13 listed)
- Active Hepatitis B, C or HIV infection
- Oxygen saturation ≤ 90% on air
- Bilirubin > 3 x upper limit of normal
- Creatinine > 3 x upper limit of normal
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| LeukapheresisPatients will undergo an unstimulated leukapheresis to isolate the required immune cells to produce the CD19+CD22 CAR T-cells | Procedure or surgery | CD19+CD22 CAR T-cells |
| Total Body Irradiation (TBI)Participants will receive low-dose total body irradiation delivered as a single fraction on day -7 prior to CD19+CD22CAR T-cell infusion. | Radiation | CD19+CD22 CAR T-cells |
| Lymphodepletion with FludarabinePatients will receive lymphodepleting chemotherapy with iv fludarabine on days -6 to -3 prior to CD19+CD22CAR T-cell infusion. | Drug | CD19+CD22 CAR T-cells |
| Lymphodepletion with CyclophosphamidePatients will receive lymphodepleting chemotherapy with iv cyclophosphamide on days -6 to -5 prior to CD19+CD22CAR T-cell infusion. | Drug | CD19+CD22 CAR T-cells |
| CD19+CD22 CAR T-cells1 dose of CD19+CD22 CAR T-cells given as an intravenous injection through a Hickman line or PICC line (peripherally inserted central catheter) on day 0. | Biological | CD19+CD22 CAR T-cells |
Primary outcome
Incidence of unacceptable toxicity following CD19+CD22 CAR T-cell infusion
Time frame: 28 days
The incidence of unacceptable toxicity occurring within 28 days of CD19+CD22CAR T-cell infusion.
Molecular remission
Time frame: 28 days
Efficacy will be assessed by determining Minimal Residual Disease in the bone marrow aspirate using immunoglobulin heavy chain (IgH) quantitative polymerase chain reaction (qPCR) and/or Next Generation Sequencing in all patients. The proportion of patients achieving molecular remission at 28 days post CD19+CD22CAR T-cell infusion will be determined.
10 secondary outcomes
Feasibility of Generation of CD19+CD22 CAR T-cells
Time frame: Day 28
Molecular Remission
Time frame: 3 months
Long-Term Molecular Remission
Time frame: 2 years
Duration of Response
Time frame: 15 years
Safety and Tolerability of the CAR T-cells
Time frame: 15 years
Incidence of B Aplasia
Time frame: 2 years
Incidence of Hypogammaglobulinaemia
Time frame: 2 years
Frequency of Circulating CD19+CD22 CAR T-cells
Time frame: 2 years
Relapse rate
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 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 22 May 2026.
- Derived from this study: PubMed 37647647Ghorashian S, Lucchini G, Richardson R, Nguyen K, Terris C, Guvenel A, Oporto-Espuelas M, Yeung J, Pinner D, Chu J, Williams L, Ko KY, Walding C, Watts K, Inglott S, Thomas R, Connor C, Adams S, Gravett E, Gilmour K, Lal A, Kunaseelan S, Popova B, Lopes A, Ngai Y, Hackshaw A, Kokalaki E, Carulla MB, Mullanfiroze K, Lazareva A, Pavasovic V, Rao A, Bartram J, Vora A, Chiesa R, Silva J, Rao K, Bonney D, Wynn R, Pule M, Hough R, Amrolia PJ. CD19/CD22 targeting with cotransduced CAR T cells to prevent antigen-negative relapse after CAR T-cell therapy for B-cell ALL. Blood. 2024 Jan 11;143(2):118-123. doi: 10.1182/blood.2023020621.
- Derived from this study: PubMed 36945773Kokalaki E, Ma B, Ferrari M, Grothier T, Hazelton W, Manzoor S, Costu E, Taylor J, Bulek A, Srivastava S, Gannon I, Jha R, Gealy R, Stanczuk L, Rizou T, Robson M, El-Kholy M, Baldan V, Righi M, Sillibourne J, Thomas S, Onuoha S, Cordoba S, Pule M. Dual targeting of CD19 and CD22 against B-ALL using a novel high-sensitivity aCD22 CAR. Mol Ther. 2023 Jul 5;31(7):2089-2104. doi: 10.1016/j.ymthe.2023.03.020. Epub 2023 Mar 21.
- Derived from this study: PubMed 31477906Ghorashian S, Kramer AM, Onuoha S, Wright G, Bartram J, Richardson R, Albon SJ, Casanovas-Company J, Castro F, Popova B, Villanueva K, Yeung J, Vetharoy W, Guvenel A, Wawrzyniecka PA, Mekkaoui L, Cheung GW, Pinner D, Chu J, Lucchini G, Silva J, Ciocarlie O, Lazareva A, Inglott S, Gilmour KC, Ahsan G, Ferrari M, Manzoor S, Champion K, Brooks T, Lopes A, Hackshaw A, Farzaneh F, Chiesa R, Rao K, Bonney D, Samarasinghe S, Goulden N, Vora A, Veys P, Hough R, Wynn R, Pule MA, Amrolia PJ. Enhanced CAR T cell expansion and prolonged persistence in pediatric patients with ALL treated with a low-affinity CD19 CAR. Nat Med. 2019 Sep;25(9):1408-1414. doi: 10.1038/s41591-019-0549-5. Epub 2019 Sep 2.
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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.
Persis Amrolia study chair
UCL Institute of Child Health
3 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 Leukapheresis, Total Body Irradiation (TBI) and Lymphodepletion with Fludarabine in people with Acute Lymphoblastic Leukemia, run by University College, London at 3 sites in United Kingdom.
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 13 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 Aniqa Tasnim (0203 108 4753, ctc.carpall@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of unacceptable toxicity following CD19+CD22 CAR T-cell infusion (time frame: 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?
On the ClinicalTrials.gov record for NCT02443831, which also lists 3 linked publications.
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 May 2026.