LymphomaPhase 1CHARKALLNCT00881920
Kappa-CD28 T Lymphocytes, Chronic Lymphocytic Leukemia, B-cell Lymphoma or Multiple Myeloma, CHARKALL
A Phase 1 study testing Kappa CD28 T cells in people with Lymphoma and Myeloma, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Patients have a type of cancer called NHL, Multiple Myeloma (MM) or CLL that has come back or has not gone away after treatment. There is no standard treatment for the cancer at this time or the currently used treatments do not work completely in all cases like these. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Kappa CD28 T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to Jul 2035
- 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
- BLOOD PROCUREMENT:
- B-CLL or recurrent or refractory B-cell lymphoma (or other B-cell neoplasm) or multiple myeloma monoclonal for Kappa-light chain
- Life expectancy of at least 12 weeks or greater.
- No history of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry
- If requires pheresis to collect blood, Cre and AST less than 1.5 upper limit of normal
- If requires pheresis to collect blood, PT and PTTK less than 1.5 upper limit normal
Show all 37Show fewer
- T CELL TREATMENT:
- Diagnosis of:
- B-CLL monoclonal for Kappa light chain with one of the following criteria:
- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
- Massive (ie, at least 6 cm below the left costal margin) or progressive or symptomatic splenomegaly
- Massive nodes (ie, at least 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
- Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months.
- Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs:
- Unintentional weight loss of 10% or more within the previous 6 months;
- Significant fatigue (ie, ECOG PS 2 or worse; inability to work or perform usual activities);
- Fevers higher than 100.5°F or 38.0°C for 2 or more weeks without other evidence of infection; or
- Night sweats for more than 1 month without evidence of infection.
- Patients who have resistant disease after primary treatment
- Patients who have a short time to progression after the first treatment (less than 2 years)
- OR
- Indolent or aggressive B-cell lymphoma (or other B-cell neoplasm) monoclonal for Kappa-light chain with measurable disease after receiving at least one chemotherapy regimen that includes Rituximab or an equivalent monoclonal antibody
- OR
- Multiple myeloma monoclonal for Kappa-light chain with measurable disease after receiving at least one chemotherapy regimen
- Life expectancy of at least 12 weeks or greater.
- Recovered from the toxic effects of all prior chemotherapy before entering this study. PD1/PDL1 inhibitors will be allowed if medically indicated
- ANC > 500, Hgb greater than or equal to 7.0.
- Bilirubin less than 3 times the upper limit of normal.
- AST less than 5 times the upper limit of normal.
- Estimated GFR > 50mL/min
- Pulse oximetry of > 90% on room air
- Karnofsky score of > 60%.
- Negative serology for HIV.
- Available autologous transduced peripheral blood T-cells with 15% or more expression of CAR-Kappa determined by flow-cytometry.
- Patients must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients will be given a copy of the consent form.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.
- If patient has CLL, must have negative Coombs test.
Who cannot join
- BLOOD PROCUREMENT:
- Active infection requiring antibiotics
- Active autoimmune disease
- T CELL TREATMENT:
- Symptomatic cardiac disease.
- History of hypersensitivity reactions to murine protein-containing products. Currently receiving any investigational agents within the previous six weeks or received any tumor vaccines within the previous 6 weeks.
- Tumor in a location where enlargement could cause airway obstruction.
- Pregnant or lactating.
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 Adoptive Transfer of Autologous T Lymphocytes Engrafted With a Chimeric Antigen Receptor Targeting the Kappa Light Chain of Immunoglobulin Expressed in Patients With CLL, B-Cell Lymphoma or Multiple Myeloma
Patients have a type of cancer called NHL, Multiple Myeloma (MM) or CLL that has come back or has not gone away after treatment. There is no standard treatment for the cancer at this time or the currently used treatments do not work completely in all cases like these. This is a gene transfer research study using special immune cells.
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, that investigators hope will work together. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells. 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
The antibody used in this study recognizes a protein on the lymphoma, MM or CLL cells called kappa immunoglobulin. Antibodies can stick to lymphoma, MM or CLL cells when it recognizes the kappa molecules present on the tumor cells. For this study, the kappa 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. These chimeric receptor-T cells seem to kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are limited.
In the laboratory, investigators found that T cells work better if they also add a protein that stimulates T cells to grow called CD28. By joining the anti-kappa antibody to the T cells and adding the CD28, the investigators expect to be able to make cells that will last for a longer time in the body (because of the presence of the CD28). They are hoping this will make the cells work better.
Previously, when patients enrolled on this study, they were assigned to one of three different doses of the kappa-CD28 T cells. We found that all three dose levels are safe. Now, the plan is to give patients the highest dose that we tested.
These chimeric T cells (kappa-CD28) are an investigational product not approved by the FDA.
Read the detailed description
To prepare the lymphoma, MM or CLL specific T cells investigators will take 240 ml (up to 16 tablespoonfuls)of blood from the patient. This would be drawn as 2 (two) separate blood collections of 120 ml (up to 8 tablespoonfuls) of blood.
To get the kappa antibody (with CD28) to attach to the surface of the T cell, investigators inserted the antibody gene 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 patient's blood after they're injected. Because the patient has received cells with a new gene in them patients will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
Several studies suggest that the infused T cells need room to be able to grow 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 level of circulating T cells is relatively high or the patient has B-CLL, the patient may receive treatment with cyclophosphamide and fludarabine (Cy and Flu) prior to the infusion of the T cells. This drug will decrease the numbers of the patients own T cells before infusion of the kappa-CD28 T cells. Although investigators don't expect any effect on the tumor with the dose that the patient will receive, this drug is part of many regimens that are used to treat lymphoma, MM or CLL. If you are already receiving chemotherapy, this may not be needed.
Patients will be given an injection of cells into the vein through an IV line. If s/he receives Cy and Flu as stated above, the T cells will be given no sooner than 24 hours afterwards. If the patient has recently received other chemotherapy, the T cells will be given at least 24 hours after their last chemotherapy. The injection will take about 20 minutes. Investigators will follow the patient in the clinic after the injection. The treatment will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.
If after a 4-6 week evaluation period after the infusion, the patient seems to be experiencing a benefit (confirmed by radiological studies, physical exam and/or symptoms), the patient may be able to receive additional doses of the T cells if they wish. These additional infusions would be at least 4-6 weeks apart and at the same dose level they received the first time or a lower dose. If the patient's circulating T cells are relatively high prior to any additional doses of T cells, they may receive Cy and Flu beforehand.
- Being tested
- Kappa CD28 T cells
- Keywords
- Lymphocytic, Leukemia, B Cell, Non-Hodgkin, Multiple Myeloma, Lymphoma
- Medical subject headings
- Lymphoma, Neoplasms, Plasma Cell, Leukemia, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kappa CD28 T cellsBiological
T cells will be given in a lymphopenic environment utilizing (as needed) lymphodepleting chemotherapy (Cy/Flu) prior to T cell infusion as outlined below:
Patients who are not lymphopenic may receive 3 daily doses of cyclophosphamide (500mg/m2/day) together with fludarabine (30mg/m2) to induce lymphopenia, finishing at least 24 hours before T cell infusion.
Patients with lymphopenia due to current drug therapy may be infused at any time starting at least 24 hours after finishing their current cycle of chemotherapy.
ASCT recipients (relapsed/refractory intermediate grade lymphoma) may be infused 14-60 days after the date of transplant.
T cell dosing is as follows:
Group 1: 2x10^7 cells/m^2 CAR-Kappa
Group 2: 1x10^8 cells/m^2 CAR-Kappa
Group 3: 2x10^8 cells/m^2 CAR-Kappa
| Study group | Role | What they receive |
|---|---|---|
| Kappa CD28 T cells for B-CLL | Experimental | T cells will be infused at least 24 hours after chemotherapy. Three dose levels will be evaluated. Cohorts of size 2 will be enrolled at each dose level. Each patient will receive one injection 2-30 mL of each dose over 1 to 20 minutes. Receives: Biological: Kappa CD28 T cells |
| Kappa CD28 T cells for B-cell lymphoma | Experimental | T cells will be infused at least 24 hours after chemotherapy. Three dose levels will be evaluated. Cohorts of size 2 will be enrolled at each dose level. Each patient will receive one injection 2-30 mL of each dose over 1 to 20 minutes. Receives: Biological: Kappa CD28 T cells |
| Kappa CD28 T cells for myeloma | Experimental | T cells will be infused at least 24 hours after chemotherapy. Three dose levels will be evaluated. Cohorts of size 2 will be enrolled at each dose level. Each patient will receive one injection 2-30 mL of each dose over 1 to 20 minutes. Receives: Biological: Kappa CD28 T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Dose-Limiting Toxicities (DLT)
DLT will be defined as any grade 3-5 toxicity that is NOT (1) pre-existing, or (2) due to infection (to which patients with CLL and NHL are so predisposed), or (3) due to underlying malignancy, and that is considered to be possibly, probably, or definitely related to the study drug. Toxicity will be evaluated using NCI criteria version 4.X.
Measured: 6 weeks
Secondary outcomes (1)
To measure the anti-tumor effects of CAR-K+ T lymphocytes.
We will summarize tumor response by calculating overall response rates. Tumor sites will be measured before and after T cell therapy using RECIST.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2018
- Study completionJul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Responsible party
- Principal investigator, Helen Heslop, Baylor College of Medicine
- Investigators
- Helen Heslop, MD, Principal investigator, Baylor College of MedicineCarlos Ramos, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881920
- Sponsor's protocol ID
- H-23574-CHARKALL
- Other IDs
- CHARKALL
- Acronym
- CHARKALL
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2009
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Naghizadeh A, Tsao WC, Hyun Cho J, Xu H, Mohamed M, Li D, Xiong W, Metaxas D, Ramos CA, Liu D. In vitro machine learning-based CAR T immunological synapse quality measurements correlate with patient clinical outcomes. PLoS Comput Biol. 2022 Mar 18;18(3):e1009883. doi: 10.1371/journal.pcbi.1009883. eCollection 2022 Mar.
PubMed 35303007Ramos CA, Savoldo B, Torrano V, Ballard B, Zhang H, Dakhova O, Liu E, Carrum G, Kamble RT, Gee AP, Mei Z, Wu MF, Liu H, Grilley B, Rooney CM, Brenner MK, Heslop HE, Dotti G. Clinical responses with T lymphocytes targeting malignancy-associated kappa light chains. J Clin Invest. 2016 Jul 1;126(7):2588-96. doi: 10.1172/JCI86000. Epub 2016 Jun 6.
PubMed 27270177
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Adoptive Transfer of Autologous T Lymphocytes Engrafted With a Chimeric Antigen Receptor Targeting the Kappa Light Chain of Immunoglobulin Expressed in Patients With CLL, B-Cell Lymphoma or Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00881920
- Acronym / sponsor ID
- CHARKALL / H-23574-CHARKALL
- Keywords
- Lymphocytic, Leukemia, B Cell, Non-Hodgkin, Multiple Myeloma, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Study start
- Jul 2009 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2035 (estimated)
- First posted
- 15 Apr 2009 (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 cancer called NHL, Multiple Myeloma (MM) or CLL that has come back or has not gone away after treatment. There is no standard treatment for the cancer at this time or the currently used treatments do not work completely in all cases like these. This is a gene transfer research study using special immune cells.
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, that investigators hope will work together. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells. 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.
The antibody used in this study recognizes a protein on the lymphoma, MM or CLL cells called kappa immunoglobulin. Antibodies can stick to lymphoma, MM or CLL cells when it recognizes the kappa molecules present on the tumor cells. For this study, the kappa 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. These chimeric receptor-T cells seem to kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are limited.
In the laboratory, investigators found that T cells work better if they also add a protein that stimulates T cells to grow called CD28. By joining the anti-kappa antibody to the T cells and adding the CD28, the investigators expect to be able to make cells that will last for a longer time in the body (because of the presence of the CD28). They are hoping this will make the cells work better.
Previously, when patients enrolled on this study, they were assigned to one of three different doses of the kappa-CD28 T cells. We found that all three dose levels are safe. Now, the plan is to give patients the highest dose that we tested.
These chimeric T cells (kappa-CD28) are an investigational product not approved by the FDA.
Detailed description
To prepare the lymphoma, MM or CLL specific T cells investigators will take 240 ml (up to 16 tablespoonfuls)of blood from the patient. This would be drawn as 2 (two) separate blood collections of 120 ml (up to 8 tablespoonfuls) of blood.
To get the kappa antibody (with CD28) to attach to the surface of the T cell, investigators inserted the antibody gene 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 patient's blood after they're injected. Because the patient has received cells with a new gene in them patients will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
Several studies suggest that the infused T cells need room to be able to grow 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 level of circulating T cells is relatively high or the patient has B-CLL, the patient may receive treatment with cyclophosphamide and fludarabine (Cy and Flu) prior to the infusion of the T cells. This drug will decrease the numbers of the patients own T cells before infusion of the kappa-CD28 T cells. Although investigators don't expect any effect on the tumor with the dose that the patient will receive, this drug is part of many regimens that are used to treat lymphoma, MM or CLL. If you are already receiving chemotherapy, this may not be needed.
Patients will be given an injection of cells into the vein through an IV line. If s/he receives Cy and Flu as stated above, the T cells will be given no sooner than 24 hours afterwards. If the patient has recently received other chemotherapy, the T cells will be given at least 24 hours after their last chemotherapy. The injection will take about 20 minutes. Investigators will follow the patient in the clinic after the injection. The treatment will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.
If after a 4-6 week evaluation period after the infusion, the patient seems to be experiencing a benefit (confirmed by radiological studies, physical exam and/or symptoms), the patient may be able to receive additional doses of the T cells if they wish. These additional infusions would be at least 4-6 weeks apart and at the same dose level they received the first time or a lower dose. If the patient's circulating T cells are relatively high prior to any additional doses of T cells, they may receive Cy and Flu beforehand.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kappa CD28 T cells for B-CLL | Experimental | Biological: Kappa CD28 T cellsT cells will be infused at least 24 hours after chemotherapy. Three dose levels will be evaluated. Cohorts of size 2 will be enrolled at each dose level. Each patient will receive one injection 2-30 mL of each dose over 1 to 20 minutes. |
| Kappa CD28 T cells for B-cell lymphoma | Experimental | Biological: Kappa CD28 T cellsT cells will be infused at least 24 hours after chemotherapy. Three dose levels will be evaluated. Cohorts of size 2 will be enrolled at each dose level. Each patient will receive one injection 2-30 mL of each dose over 1 to 20 minutes. |
| Kappa CD28 T cells for myeloma | Experimental | Biological: Kappa CD28 T cellsT cells will be infused at least 24 hours after chemotherapy. Three dose levels will be evaluated. Cohorts of size 2 will be enrolled at each dose level. Each patient will receive one injection 2-30 mL of each dose over 1 to 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- B-CLL or recurrent or refractory B-cell lymphoma (or other B-cell neoplasm) or multiple myeloma monoclonal for Kappa-light chain
- Life expectancy of at least 12 weeks or greater.
- No history of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry
- If requires pheresis to collect blood, Cre and AST less than 1.5 upper limit of normal
- If requires pheresis to collect blood, PT and PTTK less than 1.5 upper limit normal
Key exclusion criteria (8 listed)
- Active infection requiring antibiotics
- Active autoimmune disease
- Symptomatic cardiac disease.
- History of hypersensitivity reactions to murine protein-containing products. Currently receiving any investigational agents within the previous six weeks or received any tumor vaccines within the previous 6 weeks.
- Tumor in a location where enlargement could cause airway obstruction.
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 |
|---|---|---|
| Kappa CD28 T cellsT cells will be given in a lymphopenic environment utilizing (as needed) lymphodepleting chemotherapy (Cy/Flu) prior to T cell infusion as outlined below: Patients who are not lymphopenic may receive 3 daily doses of cyclophosphamide (500mg/m2/day) together with fludarabine (30mg/m2) to induce lymphopenia, finishing at least 24 hours before T cell infusion. Patients with lymphopenia due to current drug therapy may be infused at any time starting at least 24 hours after finishing their current cycle of chemotherapy. ASCT recipients (relapsed/refractory intermediate grade lymphoma) may be infused 14-60 days after the date of transplant. T cell dosing is as follows: Group 1: 2x10^7 cells/m^2 CAR-Kappa Group 2: 1x10^8 cells/m^2 CAR-Kappa Group 3: 2x10^8 cells/m^2 CAR-Kappa | Biological | Kappa CD28 T cells for B-CLL, Kappa CD28 T cells for B-cell lymphoma, Kappa CD28 T cells for myeloma |
Primary outcome
Number of Patients with Dose-Limiting Toxicities (DLT)
Time frame: 6 weeks
DLT will be defined as any grade 3-5 toxicity that is NOT (1) pre-existing, or (2) due to infection (to which patients with CLL and NHL are so predisposed), or (3) due to underlying malignancy, and that is considered to be possibly, probably, or definitely related to the study drug. Toxicity will be evaluated using NCI criteria version 4.X.
1 secondary outcome
To measure the anti-tumor effects of CAR-K+ T lymphocytes.
Time frame: 6 weeks
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 5 Oct 2026.
- Derived from this study: PubMed 35303007Naghizadeh A, Tsao WC, Hyun Cho J, Xu H, Mohamed M, Li D, Xiong W, Metaxas D, Ramos CA, Liu D. In vitro machine learning-based CAR T immunological synapse quality measurements correlate with patient clinical outcomes. PLoS Comput Biol. 2022 Mar 18;18(3):e1009883. doi: 10.1371/journal.pcbi.1009883. eCollection 2022 Mar.
- Derived from this study: PubMed 27270177Ramos CA, Savoldo B, Torrano V, Ballard B, Zhang H, Dakhova O, Liu E, Carrum G, Kamble RT, Gee AP, Mei Z, Wu MF, Liu H, Grilley B, Rooney CM, Brenner MK, Heslop HE, Dotti G. Clinical responses with T lymphocytes targeting malignancy-associated kappa light chains. J Clin Invest. 2016 Jul 1;126(7):2588-96. doi: 10.1172/JCI86000. Epub 2016 Jun 6.
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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 Heslop, MD principal investigator
Baylor College of Medicine
Carlos Ramos, MD principal investigator
The Methodist Hospital Research Institute
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 Kappa CD28 T cells in people with Lymphoma and Myeloma, 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 37 inclusion and 8 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 5 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 Toxicities (DLT) (time frame: 6 weeks). 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 NCT00881920, which also lists 2 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 5 Oct 2026.