Non-Hodgkin's LymphomaPhase 1CARPASCIONCT02050347
Activated T Lymphocytes Expressing CARs, Relapsed CD19+ Malignancies Post-Allo HSCT(CARPASCIO)
A Phase 1 study testing CD19.CAR-CD28Z T Cells - dose escalation 2 and CD19.CAR-CD28Z T Cells - dose escalation 1 in people with Non-Hodgkin's Lymphoma and B-Cell ALL, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Patients have a type of lymph gland cancer called Non-Hodgkin Lymphoma (NHL), acute lymphocytic leukemia (ALL) or chronic lymphocytic leukemia (CLL) (these diseases will be referred to as "lymphoma" or "leukemia"). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Hodgkin's Lymphoma, B-Cell ALL, B-Cell CLL
- What is being tested?
- CD19.CAR-CD28Z T Cells - dose escalation 2 and CD19.CAR-CD28Z T Cells - dose escalation 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to Dec 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PROCUREMENT
- Group A: CD19+ B-ALL undergoing allogeneic HSCT or Group B: CD19+ B cell CLL or NHL undergoing allogeneic HSCT
- Life expectancy of ≥12 weeks.
- Patient has an appropriate donor identified for hematopoietic stem cell transplantation
- TREATMENT
- Any patient regardless of sex or age with CD19+ B-ALL undergoing allogeneic HSCT (Group A) OR any patient regardless of sex or age with CD19+ B-CLL or NHL undergoing allogeneic HSCT (Group B)
Show all 22Show fewer
- Residual disease at the time of transplant (bulky or minimal) or post transplant relapse as evidenced by PCR positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry or increased blasts on bone marrow biopsy or in the peripheral blood. MRD will be defined as detection in blood or marrow of any of the following:
- Any leukemia specific marker (such as t(9:22) or t(4:11)) documented in the patient's leukemia cells pre transplant on a post transplant evaluation.
- An immune globulin rearrangement known to be a disease marker for this patient post transplant.
- A leukemia specific phenotype post transplant at a level of ≥ 0.01%
- Mixed donor chimerism (any level)
- Life expectancy ≥ 6 weeks
- Karnofsky/Lansky score ≥ 50%.
- Bilirubin ≤ 2 times the upper limit of normal.
- AST ≤ 3 times the upper limit of normal.
- Estimated GFR > 50 mL/min
- Hgb ≥ 7.0 (can be a transfused value)
- Pulse oximetry of > 90% on room air
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after ATL infusion. The male partner should use a condom.
- Available allogeneic activated peripheral blood T cell products with >=15% expression of CD19.CAR-CD28ζ determined by flow cytometry (cell dose is based on total cell numbers and not individual antileukemic cell numbers).
- No other investigational antitumor therapy for one month prior to entry in this study.
- Patients or legal guardians must sign an informed consent.
Who cannot join
- Severe intercurrent infection.
- Evidence of GVHD > grade II.
- Pregnant or lactating.
- History of hypersensitivity reactions to murine protein-containing products.
- Currently taking corticosteroids (>0.5 mg/kg/day prednisone or equivalent) for therapy of GVHD.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Methodist Hospital
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Phase I Study of Activated T Lymphocytes Expressing Chimeric Antigen Receptors for Therapy of Relapsed CD19-Positive Malignancies Post-Allogeneic Hematopoietic Stem Cell Transplantation Infused Only After Engraftment (CARPASCIO)
Patients have a type of lymph gland cancer called Non-Hodgkin Lymphoma (NHL), acute lymphocytic leukemia (ALL) or chronic lymphocytic leukemia (CLL) (these diseases will be referred to as "lymphoma" or "leukemia"). The lymphoma or leukemia has come back or has not gone away after treatment (including the best treatment known for these cancers). Because there is no standard treatment for this cancer at this time, subjects are asked to volunteer to be in a gene transfer research study using special immune cells.
The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, hoping that they will work together. Both antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients.
Read more
T cells can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person.
The antibody used in this study is called anti-CD19. This antibody sticks to cancer cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and leukemia. For this study, the CD19 antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. The T lymphocytes will also contain CD28, which stimulates T cells and makes them last longer.
Treatment with CD19/CD28 chimeric receptor-T cells has had activity against lymphoma and leukemia when the cells are made from the patients affected by these diseases. In this study, investigators are going to see if this treatment works even better when they make these cells from a healthy stem cell donor. If investigators are not able to collect blood from the stem cell donor, they will collect blood from the subject to make the CD19/CD28 chimeric receptor-T cells.
These CD19/CD28 chimeric receptor T cells are investigational products not approved by the FDA.
The purpose of this study is to find the biggest dose of chimeric T Cells that is safe, to see how long T cells with this chimeric receptor last, to learn what the side effects are, and to see whether this therapy might help people with lymphoma or leukemia after a stem cell transplantation from a donor.
Read the detailed description
The subject or his/her donor will give blood to make CD19/CD28 chimeric receptor-T cells in the laboratory. These cells will be grown and frozen. To make the T cells, the donor/subject's blood will be stimulated with growth factors to make the T cells grow. To get the CD19 antibody with CD28 to attach to the surface of the T cell, an antibody gene will be inserted into the T cell. This is done with a virus called a retrovirus that has been made for this study and will carry the antibody gene into the T cell. This virus also helps investigators find the T cells in the blood using a special laboratory test. Subjects will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
When a subject enrolls on this study, s/he will be assigned a dose of CD19/CD28 chimeric receptor-T cells and should not receive other cancer treatment until 6 weeks after cell infusion.
Several studies suggest that the infused T cells need room to be able to proliferate and accomplish their functions and that this may not happen if there are too many other T cells in circulation. Because of that, if the subject's level of circulating T cells is relatively high, s/hemay receive treatment with cyclophosphamide (Cytoxan) and fludarabine (chemotherapy drugs) before the T cells. If the subject is already receiving chemotherapy, this may not be needed.
The subject will be given an injection of cells into the vein through an IV at the assigned dose. The injection will take up to 10 minutes. The research staff will follow the subject in the clinic after the injection for up to 4 hours. If after a 4-6 week evaluation period after the infusion, the subject seems to be experiencing a benefit (confirmed by radiological studies, physical exam and/or symptoms), s/he may be able to receive up to 5 additional doses of the T cells. These additional infusions would be at least 4-6 weeks apart and at the same dose level received the first time or a lower dose.
There will be medical tests during and after treatment. To learn more about the way the CD19 chimeric receptor-T cells are working and how long they last in the body, extra blood will be drawn.
- Conditions
- Non-Hodgkin's Lymphoma, B-Cell ALL, B-Cell CLL
- Being tested
- CD19.CAR-CD28Z T Cells - dose escalation 2, CD19.CAR-CD28Z T Cells - dose escalation 1
- Keywords
- CD19.CAR-CD28zeta, chimeric antigen receptor, hematopoietic stem cell transplant
- Medical subject headings
- Lymphoma, Non-Hodgkin, Burkitt Lymphoma, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19.CAR-CD28Z T Cells - dose escalation 2Genetic
Patients will receive one of the following dose levels:
Dose Level 1: 5 ×10^5 cells/kg
Dose Level 2: 1×10^6 cells/kg
Dose Level 3: 5×10^6 cells/kg
CD19.CAR-CD28Z T Cells - dose escalation 1Genetic
Patients will receive one of the following doses:
Dose Level one: 1x10^5 cells/kg
Dose Level 2: 5x10^5 cells/kg
Dose Level 3: 1x10^6 cells/kg
| Study group | Role | What they receive |
|---|---|---|
| Subgroup A1 | Experimental | Patients with residual or relapsed B-cell ALL and with an HLA-matched related donor will receive CD19.CAR-CD28Z T Cells - dose escalation 1 Receives: Genetic: CD19.CAR-CD28Z T Cells - dose escalation 2 |
| Subgroup B1 | Experimental | Patients with other B-cell malignancies and with an HLA-matched related donor will receive CD19.CAR-CD28Z T Cells - dose escalation 1 Receives: Genetic: CD19.CAR-CD28Z T Cells - dose escalation 2 |
| Subgroup A2 | Experimental | Patients with residual or relapsed B-cell ALL and with an unrelated or HLA-mismatched donor will receive CD19.CAR-CD28Z T Cells - dose escalation 2 Receives: Genetic: CD19.CAR-CD28Z T Cells - dose escalation 1 |
| Subgroup B2 | Experimental | Patients with other B cell malignancies and with an unrelated or HLA-mismatched donor will receive CD19.CAR-CD28Z T Cells - dose escalation 2 Receives: Genetic: CD19.CAR-CD28Z T Cells - dose escalation 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicity
Toxicity is evaluated using CTCAE, version 4.0. Dose limiting toxicity (DLT) will be defined as any of the following that is NOT (1) pre-existing, or (2) due to infection (to which patients with CLL and NHL are predisposed), or (3) due to underlying malignancy, and that may, after consultation with the FDA when indicated, be considered possibly, probably, or definitely related to the study cellular products:
- Development of Grade III-IV GVHD or Grade II GVHD unresponsive to front line treatment;
- Non-hematologic DLT is any grade 3 or grade 4 non-hematologic toxicity, including allergic reactions to T cell infusions.
- Hematologic DLT is defined as any grade 4 hematologic toxicity, including secondary graft failure (as defined per protocol).
- Patients with evidence of bone marrow disease (metastases or diffuse infiltration) are not evaluable for hematologic dose limiting toxicity.
Measured: 6 weeks
Secondary outcomes (2)
Number of patients with tumor response
We will summarize tumor response by overall response rates. Tumor burden will be measured before and after T cell therapy.
Measured: 8 weeks
Frequency of T cell products
The frequency of T cells transduced with the vector (T cells expressing CD19.CAR-CD28z) will be summarized at pre and post-infusion time points. Plots of growth curves will be generated to graphically illustrate patterns of T-cell expansion.
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 posted30 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2019
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Helen Heslop, Baylor College of Medicine
- Investigators
- Helen E Heslop, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050347
- Sponsor's protocol ID
- H-33133 CARPASCIO
- Other IDs
- CARPASCIO
- Acronym
- CARPASCIO
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2014
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Activated T Lymphocytes Expressing Chimeric Antigen Receptors for Therapy of Relapsed CD19-Positive Malignancies Post-Allogeneic Hematopoietic Stem Cell Transplantation Infused Only After Engraftment (CARPASCIO)
- ClinicalTrials.gov ID
- NCT02050347
- Acronym / sponsor ID
- CARPASCIO / H-33133 CARPASCIO
- Conditions
- Non-Hodgkin's Lymphoma, B-Cell ALL, B-Cell CLL
- Keywords
- CD19.CAR-CD28zeta, chimeric antigen receptor, hematopoietic stem cell transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Study start
- Apr 2014
- Primary completion
- Oct 2019 (actual)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Jan 2014 (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.
Patients have a type of lymph gland cancer called Non-Hodgkin Lymphoma (NHL), acute lymphocytic leukemia (ALL) or chronic lymphocytic leukemia (CLL) (these diseases will be referred to as "lymphoma" or "leukemia"). The lymphoma or leukemia has come back or has not gone away after treatment (including the best treatment known for these cancers). Because there is no standard treatment for this cancer at this time, subjects are asked to volunteer to be in a gene transfer research study using special immune cells.
The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, hoping that they will work together. Both antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients.
T cells can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person.
The antibody used in this study is called anti-CD19. This antibody sticks to cancer cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and leukemia. For this study, the CD19 antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. The T lymphocytes will also contain CD28, which stimulates T cells and makes them last longer.
Treatment with CD19/CD28 chimeric receptor-T cells has had activity against lymphoma and leukemia when the cells are made from the patients affected by these diseases. In this study, investigators are going to see if this treatment works even better when they make these cells from a healthy stem cell donor. If investigators are not able to collect blood from the stem cell donor, they will collect blood from the subject to make the CD19/CD28 chimeric receptor-T cells.
These CD19/CD28 chimeric receptor T cells are investigational products not approved by the FDA.
The purpose of this study is to find the biggest dose of chimeric T Cells that is safe, to see how long T cells with this chimeric receptor last, to learn what the side effects are, and to see whether this therapy might help people with lymphoma or leukemia after a stem cell transplantation from a donor.
Detailed description
The subject or his/her donor will give blood to make CD19/CD28 chimeric receptor-T cells in the laboratory. These cells will be grown and frozen. To make the T cells, the donor/subject's blood will be stimulated with growth factors to make the T cells grow. To get the CD19 antibody with CD28 to attach to the surface of the T cell, an antibody gene will be inserted into the T cell. This is done with a virus called a retrovirus that has been made for this study and will carry the antibody gene into the T cell. This virus also helps investigators find the T cells in the blood using a special laboratory test. Subjects will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
When a subject enrolls on this study, s/he will be assigned a dose of CD19/CD28 chimeric receptor-T cells and should not receive other cancer treatment until 6 weeks after cell infusion.
Several studies suggest that the infused T cells need room to be able to proliferate and accomplish their functions and that this may not happen if there are too many other T cells in circulation. Because of that, if the subject's level of circulating T cells is relatively high, s/hemay receive treatment with cyclophosphamide (Cytoxan) and fludarabine (chemotherapy drugs) before the T cells. If the subject is already receiving chemotherapy, this may not be needed.
The subject will be given an injection of cells into the vein through an IV at the assigned dose. The injection will take up to 10 minutes. The research staff will follow the subject in the clinic after the injection for up to 4 hours. If after a 4-6 week evaluation period after the infusion, the subject seems to be experiencing a benefit (confirmed by radiological studies, physical exam and/or symptoms), s/he may be able to receive up to 5 additional doses of the T cells. These additional infusions would be at least 4-6 weeks apart and at the same dose level received the first time or a lower dose.
There will be medical tests during and after treatment. To learn more about the way the CD19 chimeric receptor-T cells are working and how long they last in the body, extra blood will be drawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subgroup A1 | Experimental | Genetic: CD19.CAR-CD28Z T Cells - dose escalation 2Patients with residual or relapsed B-cell ALL and with an HLA-matched related donor will receive CD19.CAR-CD28Z T Cells - dose escalation 1 |
| Subgroup B1 | Experimental | Genetic: CD19.CAR-CD28Z T Cells - dose escalation 2Patients with other B-cell malignancies and with an HLA-matched related donor will receive CD19.CAR-CD28Z T Cells - dose escalation 1 |
| Subgroup A2 | Experimental | Genetic: CD19.CAR-CD28Z T Cells - dose escalation 1Patients with residual or relapsed B-cell ALL and with an unrelated or HLA-mismatched donor will receive CD19.CAR-CD28Z T Cells - dose escalation 2 |
| Subgroup B2 | Experimental | Genetic: CD19.CAR-CD28Z T Cells - dose escalation 1Patients with other B cell malignancies and with an unrelated or HLA-mismatched donor will receive CD19.CAR-CD28Z T Cells - dose escalation 2 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- PROCUREMENT
- Group A: CD19+ B-ALL undergoing allogeneic HSCT or Group B: CD19+ B cell CLL or NHL undergoing allogeneic HSCT
- Life expectancy of ≥12 weeks.
- Patient has an appropriate donor identified for hematopoietic stem cell transplantation
- TREATMENT
Key exclusion criteria (5 listed)
- Severe intercurrent infection.
- Evidence of GVHD > grade II.
- Pregnant or lactating.
- History of hypersensitivity reactions to murine protein-containing products.
- Currently taking corticosteroids (>0.5 mg/kg/day prednisone or equivalent) for therapy of GVHD.
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 |
|---|---|---|
| CD19.CAR-CD28Z T Cells - dose escalation 2Patients will receive one of the following dose levels: Dose Level 1: 5 ×10^5 cells/kg Dose Level 2: 1×10^6 cells/kg Dose Level 3: 5×10^6 cells/kg | Genetic | Subgroup A1, Subgroup B1 |
| CD19.CAR-CD28Z T Cells - dose escalation 1Patients will receive one of the following doses: Dose Level one: 1x10^5 cells/kg Dose Level 2: 5x10^5 cells/kg Dose Level 3: 1x10^6 cells/kg | Genetic | Subgroup A2, Subgroup B2 |
Primary outcome
Number of patients with dose limiting toxicity
Time frame: 6 weeks
Toxicity is evaluated using CTCAE, version 4.0. Dose limiting toxicity (DLT) will be defined as any of the following that is NOT (1) pre-existing, or (2) due to infection (to which patients with CLL and NHL are predisposed), or (3) due to underlying malignancy, and that may, after consultation with the FDA when indicated, be considered possibly, probably, or definitely related to the study cellular products: * Development of Grade III-IV GVHD or Grade II GVHD unresponsive to front line treatment; * Non-hematologic DLT is any grade 3 or grade 4 non-hematologic toxicity, including allergic reactions to T cell infusions. * Hematologic DLT is defined as any grade 4 hematologic toxicity, including secondary graft failure (as defined per protocol). * Patients with evidence of bone marrow disease (metastases or diffuse infiltration) are not evaluable for hematologic dose limiting toxicity.
2 secondary outcomes
Number of patients with tumor response
Time frame: 8 weeks
Frequency of T cell products
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 2 Oct 2026.
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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.
Helen E Heslop, MD principal investigator
Baylor College of Medicine
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 CD19.CAR-CD28Z T Cells - dose escalation 2 and CD19.CAR-CD28Z T Cells - dose escalation 1 in people with Non-Hodgkin's Lymphoma and B-Cell ALL, run by Baylor College of Medicine at 2 sites in United States.
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 22 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with dose limiting toxicity (time frame: 6 weeks). 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 2 Oct 2026.