LymphomaPhase 1CALySSEYNCT07297160
CD70.CAR for CD70+ Lymphoma, Myeloma and Solid Tumors
A Phase 1 study testing Dose Level -1, Dose Level 1 (starting dose level) and Dose Level 2 in people with Lymphoma and Myeloma, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
This study is for patients who have a type of cancer that expresses the protein CD70, which includes lymphoma (lymph gland cancer), myeloma and solid tumors including some sarcomas and kidney cancers, and the cancer has come back or has not gone away after standard of care treatment. Read more about this study
- Who is it for?
- Ages 0 to 75 years
- Conditions the study is for
- Lymphoma, Myeloma, Solid Tumors
- What is being tested?
- Dose Level -1, Dose Level 1 (starting dose level) and Dose Level 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2026to Dec 2044
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
PROCUREMENT INCLUSION CRITERIA:
- Diagnosis of relapsed/refractory T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin Lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell lymphoma (lymphoma or chronic subtypes, Extranodal NK/T cell lymphoma, Mycosis fungoides (excluding Sezary Syndrome Stage IIB or higher) or multiply relapsed Hodgkin Lymphoma
OR
Patients with relapsed/refractory Renal Cell Carcinoma (RCC) OR sarcomas (for sarcoma only patients age 25 or younger are eligible)
OR
Patients with relapsed or refractory multiple myeloma (MM) that have failed or are ineligible for the 3 main classes of MM therapy ("triple class refractory")
(3 classes: 1. Immunomodulatory drugs, 2. proteosome inhibitors and 3. Anti-CD38 monoclonal antibodies).
- CD70 positive tumor with at least 26% CD70+ tumor cells by immunohistochemistry (staining can be pending at time of procurement)
- Age ≤75 years (except for sarcoma: only patients age ≤25 are eligible) NOTE: The first three (3) patients treated on the study will be adults (≥18 years of age)
- Hemoglobin ≥ 7.0 g/dL (can be transfused)
- If apheresis required to collect blood, PT and aPTT <1.5x ULN; Serum Creatinine < 2 x ULN; AST < 5 x ULN.
PROCUREMENT EXCLUSION CRITERIA:
- Active infection (bacterial, fungal or viral) requiring ongoing treatment without improvement.
- Known active infection with HIV or HTLV (collected blood will be sent for HIV/HTLV testing, separate testing prior to procurement not required). Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is >350 mm3.
- Active second cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) or other cancer treated ≤ 2 years prior to enrollment
- Ongoing treatment with immune suppression for prophylaxis/treatment of GVHD including high dose steroids (e.g., prednisone > 0.5 mg/kg/day).
TREATMENT INCLUSION CRITERIA:
- Diagnosis of relapsed/refractory T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin Lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell lymphoma (lymphoma or chronic subtypes), , Extranodal NK/T cell lymphoma, Mycosis fungoides (excluding Sezary Syndrome Stage IIB or higher) or multiply relapsed Hodgkin Lymphoma
OR
Patients with relapsed/refractory Renal Cell Carcinoma (RCC) or sarcomas (for sarcoma only patients age 25 or younger are eligible)
OR
Patients with relapsed or refractory multiple myeloma (MM) that have failed or are ineligible for the 3 main classes of MM therapy ("triple class refractory") and also failed or ineligible for anti-BCMA therapies.
(3 classes: 1. Immunomodulatory drugs, 2. proteosome inhibitors and 3. Anti-CD38 monoclonal antibodies).
- CD70 positive tumor with at least 26% CD70+ tumor cells by immunohistochemistry (tissue)
- No systemic chemotherapy at least 2 weeks prior to treatment on study and must be recovered from all acute toxic effects of prior chemotherapy at time of treatment
- Age ≤75 years. (except for sarcoma: only patients age ≤25 are eligible) NOTE: The first three (3) patients treated on the study will be adults (≥18 years of age).
- Hemoglobin ≥ 7.0 g/dL (can be transfused)
- Total bilirubin < 3 times the upper limit of normal
- AST/ALT < 5 times the upper limit of normal
- Creatinine < 2 times the upper limit of normal
- Pulse oximetry of > 90% on room air
- Karnofsky or Lansky score of ≥60%
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. Male partner should use a condom.
- Informed Consent Obtained.
TREATMENT EXCLUSION CRITERIA:
- Received investigational anti-cancer agents < 28 days or 5 half-lives, whichever is shorter
- Received any tumor vaccines within the previous 6 weeks
- Pregnant or lactating
- Uncontrolled infection with HIV, or HTLV. Patients with HIV are eligible if viral load is undetectable on therapy and CD4 count is >350 mm3.
- Clinically significant bacterial, fungal, or viral infection requiring ongoing therapy without improvement.
- Cardiac abnormalities: Cardiac echocardiography with LVEF<50%; Cardiac dysfunction NYHA III or IV; Clinically significant pericardial effusion. Confirmation of absence of these conditions must be obtained within 6 months of treatment.
- Use of serotherapy with Campath or Anti-Thymocyte Globulin (ATG) within the last 28 days
- Use of Donor Lymphocyte Infusion (DLI) or other cellular therapy product within 28 days.
- Acute GVHD ≥ Grade 2 or moderate to severe (formerly extensive) chronic GVHD.
- High dose steroids >1 mg/kg within the preceding 5 days or currently receiving >0.5 mg/kg/day prednisone equivalent.
- Bulky CNS or mediastinal disease that significantly increases potential risks (e.g. airway obstruction, TIAN) in the estimation of a principal investigator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Children's Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
About this study
Official title: Chimeric Antigen Receptor Treatment Targeting Lymphoma, Myeloma and Solid Tumors That Express CD70 (SEventY) CALySSEY
This study is for patients who have a type of cancer that expresses the protein CD70, which includes lymphoma (lymph gland cancer), myeloma and solid tumors including some sarcomas and kidney cancers, and the cancer has come back or has not gone away after standard of care treatment.
As there are limited or no remaining standard treatments available to treat this cancer, patients are being asked to volunteer to be in a gene transfer research study using special immune cells to create a specialized immune cell that will recognize a protein called CD70 that is expressed on the outside surface of the tumor cells in the body.
Read more
This research study combines different ways of fighting disease by using T cells and "arming" them to recognize a specific protein on cancer cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. T cells by themselves have been used to treat patients with cancers and have shown promise, but have not been strong enough to cure most patients.
The protein used in this study is called anti-CD70. It has been developed from human CD27 on normal T cells, since it is the natural binding partner that can connect with CD70. This anti-CD70 protein sticks to tumor cells when it binds to CD70. CD70 binders have been used to treat people with different types of cancers. For this study, anti-CD70 has been changed so that instead of floating free in the blood it is now joined to the T cells. When binder is joined to a T cell in this way it is called a chimeric receptor or "CAR T cell". The doctors then made another change to cause these T cells to kill any cell that has CD70. This causes the "CAR T cells" to kill blood cancer cells which are confirmed to have CD70.
In the laboratory, investigators have found that T cells work better if there are proteins added that stimulate T cells. The anti-CD70 (CD27) protein is unique because it can bind to CD70 on tumor cells but also stimulates the T cells that express it. Adding the CD27 makes the cells grow better and may help them to last longer in the body, thus giving the cells a better chance of killing the tumor cells.
These CD70 "CAR" T cells are investigational products not approved by the Food and Drug Administration.
The purpose of this study is to find a dose of CAR T cells that is safe, to learn what the side effects are and to see whether this therapy might help people with lymphoma (lymph gland cancer), myeloma and certain solid tumors including some sarcomas and kidney cancers.
Read the detailed description
Blood will be collected from the patient to make CD70 CAR T cells. To make the T cells the blood will be stimulated with growth factors to make the T cells grow. To get the CD70 binder to attach to the surface of the T cell, investigators will insert the 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 the investigators find the T cells in the blood after they are injected. To ensure the T cells grow well in the lab, investigators may add small amounts of medications that are often used to treat patients with cancer or other illnesses. These medications are washed off of the cells prior to injecting them into the patient's body. Because the patient will have received cells with a new gene in them, the patient will be followed for a total of 15 years to see if there are any long-term side effects of gene transfer. If the patient cannot visit the clinic, the patient may be contacted by the research coordinator or physician by phone or in other ways.
When the patient enrolls on this study, they will be assigned a dose of CD70 CAR T cells. Several studies suggest that the infused T cells need room to be able to proliferate (grow) and accomplish their functions and that this may not happen if there are too many other T cells in the blood. Because of that, the patient will receive two chemotherapy medications prior to receiving the CD70 CAR T cells. One medication is called cyclophosphamide and the other fludarabine. The patient will receive 3 daily doses of each drug, ending at least one day before receiving the CAR T cells. These drugs will decrease the numbers of the patients own T cells before infusion of the CD70 CAR T cells and also will help decrease the number of other cells that may interfere with the CAR T cells working well. Although there is no effect expected on the patient's tumor with the doses they will receive, these drugs are part of many regimens that are used to treat cancer. The investigators would prefer that the patient does not receive other chemotherapy or treatments for their cancer until 4 weeks after their cell infusion but the patient can do so if their doctor thinks it is medically necessary.
The patient will be given an injection of cells into the vein through an IV at the assigned dose. Before receiving the injection, the patient might be given a dose of Benadryl and Tylenol. The injection will take about 1-10 minutes. If no significant toxicities or signs of adverse/bad effects are seen right after infusion, the patient will be monitored for at least 2 hours post infusion. The patient will have to remain locally for at least 4 weeks after the infusion. If the patient experiences any side effects, they may have to be hospitalized for evaluation and management.
Medical Test Before Treatment:
- Physical exam and History
- Blood tests to measure blood cells, kidney and liver function
- Measurements of tumor by scans and/or bone marrow studies
- Testing of blood for certain viral infections
- An ultrasound of the heart to make sure the heart function is appropriate for the study if one has not been done recently
Medical Tests During and After Treatment:
- Physical exams and History
- Blood tests to measure blood cells, kidney and liver function
- Measurements of tumor by scans and/or bone marrow studies 4 weeks after the infusion
To learn more about the way the CD70 CAR T cells are working and how long they last in the body, extra blood will be drawn. The total amount on any day is about 10 teaspoons (50 mL) or no more than 3 mL per 2.2 pounds (3 ml per kilogram) body weight in children. This volume is considered safe but may be decreased if patient is anemic (decreased number of red blood cells). This blood may be drawn from a central line. Blood will be taken before starting chemotherapy a few days prior to the cell infusion. On the day patient receives the cells, blood will be taken before the cells are given and several hours afterwards. Other blood will be drawn one week after the infusion, 2 weeks, 3 weeks, 4 weeks 6 and 8 weeks after the infusion, at 3 months, at 6 months, at 9 months, at 1 year, every 6 months for 4 years, then yearly for a total of 15 years.
If the patient has a biopsy of their tumor or bone marrow studies in the future after completing this study, the investigators may ask to have a piece of tumor or bone marrow to look for CD70 CAR T cells.
In the event of the patient's death, the investigators will request permission to perform an autopsy to learn more about the effect of this experimental treatment on the tumor.
- Conditions
- Lymphoma, Myeloma, Solid Tumors, Sarcoma, Kidney Cancer
- Being tested
- Dose Level -1, Dose Level 1 (starting dose level), Dose Level 2, Dose Level 3
- Keywords
- Lymphoma, Myeloma, Solid Tumors, T cell, CD70.CAR T-cells, Blood Cancer, Lymph Gland Cancer
- Medical subject headings
- Lymphoma, Neoplasms, Plasma Cell, Sarcoma, Kidney Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose Level -1Biological
Dose Level -1: 3 x 10^5 cells/kg
Dose Level 1 (starting dose level)Biological
Dose Level 1 (starting dose level): 1 x 10^6 cells/kg
Dose Level 2Biological
Dose Level 2: 3 x 10^6 cells/kg
Dose Level 3Biological
Dose Level 3: 1 x 10^7 cells/kg
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A - Lymphoma and Solid Tumors | Experimental | CD70.CAR: Three dose levels, and a possible dose level -1 in case of unexpected toxicity at dose level 1, will be evaluated for patients with lymphoma and solid tumors. Each patient will receive one T cell infusion. Dose levels will be defined based on number of transduced T cells measured by flow cytometry.
The first three patients treated on the study will be adults 18 years of age or older, which can be treated in each cohort. Receives: Biological: Dose Level -1; Biological: Dose Level 1 (starting dose level); Biological: Dose Level 2; Biological: Dose Level 3 |
| Treatment Arm B - Myeloma | Experimental | CD70.CAR: Three dose levels, and a possible dose level -1 in case of unexpected toxicity at dose level 1, will be evaluated for patients with myeloma. Each patient will receive one T cell infusion. Dose levels will be defined based on number of transduced T cells measured by flow cytometry.
The first three patients treated on the study will be adults 18 years of age or older, which can be treated in each cohort. Receives: Biological: Dose Level -1; Biological: Dose Level 1 (starting dose level); Biological: Dose Level 2; Biological: Dose Level 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT) rate
Toxicity for all patients will be evaluated using the NCI Common Toxicity Criteria Scale with the exception of CRS and immune effector cell associated neurotoxicity (ICANS). CRS and ICANS will be graded per ASTCT consensus grading criteria.
Measured: 4 weeks post infusion
Secondary outcomes (1)
Overall response rate
The study will use the revised response criteria for malignant lymphoma to evaluate response in patients with T-cell lymphoma and the international myeloma working group response assessment guidelines for MM. Patients with solid tumors (RCC and sarcomas) will be assessed by iRECIST criteria.
Measured: 6-8 weeks post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study startJun 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2044 (estimated)
Why it stopped: The study was revised into two separate protocols to separate treatments. We will submit as separate studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 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, Bilal Omer, Baylor College of Medicine
- Investigators
- Bilal Omer, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297160
- Sponsor's protocol ID
- H-55493 CALySSEY
- Acronym
- CALySSEY
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chimeric Antigen Receptor Treatment Targeting Lymphoma, Myeloma and Solid Tumors That Express CD70 (SEventY) CALySSEY
- ClinicalTrials.gov ID
- NCT07297160
- Acronym / sponsor ID
- CALySSEY / H-55493 CALySSEY
- Conditions
- Lymphoma, Myeloma, Solid Tumors, Sarcoma, Kidney Cancer
- Keywords
- Lymphoma, Myeloma, Solid Tumors, T cell, CD70.CAR T-cells, Blood Cancer, Lymph Gland Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was revised into two separate protocols to separate treatments. We will submit as separate studies.
- Enrolment
- 0 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
- Jun 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2044 (estimated)
- First posted
- 22 Dec 2025 (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 is for patients who have a type of cancer that expresses the protein CD70, which includes lymphoma (lymph gland cancer), myeloma and solid tumors including some sarcomas and kidney cancers, and the cancer has come back or has not gone away after standard of care treatment.
As there are limited or no remaining standard treatments available to treat this cancer, patients are being asked to volunteer to be in a gene transfer research study using special immune cells to create a specialized immune cell that will recognize a protein called CD70 that is expressed on the outside surface of the tumor cells in the body.
This research study combines different ways of fighting disease by using T cells and "arming" them to recognize a specific protein on cancer cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. T cells by themselves have been used to treat patients with cancers and have shown promise, but have not been strong enough to cure most patients.
The protein used in this study is called anti-CD70. It has been developed from human CD27 on normal T cells, since it is the natural binding partner that can connect with CD70. This anti-CD70 protein sticks to tumor cells when it binds to CD70. CD70 binders have been used to treat people with different types of cancers. For this study, anti-CD70 has been changed so that instead of floating free in the blood it is now joined to the T cells. When binder is joined to a T cell in this way it is called a chimeric receptor or "CAR T cell". The doctors then made another change to cause these T cells to kill any cell that has CD70. This causes the "CAR T cells" to kill blood cancer cells which are confirmed to have CD70.
In the laboratory, investigators have found that T cells work better if there are proteins added that stimulate T cells. The anti-CD70 (CD27) protein is unique because it can bind to CD70 on tumor cells but also stimulates the T cells that express it. Adding the CD27 makes the cells grow better and may help them to last longer in the body, thus giving the cells a better chance of killing the tumor cells.
These CD70 "CAR" T cells are investigational products not approved by the Food and Drug Administration.
The purpose of this study is to find a dose of CAR T cells that is safe, to learn what the side effects are and to see whether this therapy might help people with lymphoma (lymph gland cancer), myeloma and certain solid tumors including some sarcomas and kidney cancers.
Detailed description
Blood will be collected from the patient to make CD70 CAR T cells. To make the T cells the blood will be stimulated with growth factors to make the T cells grow. To get the CD70 binder to attach to the surface of the T cell, investigators will insert the 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 the investigators find the T cells in the blood after they are injected. To ensure the T cells grow well in the lab, investigators may add small amounts of medications that are often used to treat patients with cancer or other illnesses. These medications are washed off of the cells prior to injecting them into the patient's body. Because the patient will have received cells with a new gene in them, the patient will be followed for a total of 15 years to see if there are any long-term side effects of gene transfer. If the patient cannot visit the clinic, the patient may be contacted by the research coordinator or physician by phone or in other ways.
When the patient enrolls on this study, they will be assigned a dose of CD70 CAR T cells. Several studies suggest that the infused T cells need room to be able to proliferate (grow) and accomplish their functions and that this may not happen if there are too many other T cells in the blood. Because of that, the patient will receive two chemotherapy medications prior to receiving the CD70 CAR T cells. One medication is called cyclophosphamide and the other fludarabine. The patient will receive 3 daily doses of each drug, ending at least one day before receiving the CAR T cells. These drugs will decrease the numbers of the patients own T cells before infusion of the CD70 CAR T cells and also will help decrease the number of other cells that may interfere with the CAR T cells working well. Although there is no effect expected on the patient's tumor with the doses they will receive, these drugs are part of many regimens that are used to treat cancer. The investigators would prefer that the patient does not receive other chemotherapy or treatments for their cancer until 4 weeks after their cell infusion but the patient can do so if their doctor thinks it is medically necessary.
The patient will be given an injection of cells into the vein through an IV at the assigned dose. Before receiving the injection, the patient might be given a dose of Benadryl and Tylenol. The injection will take about 1-10 minutes. If no significant toxicities or signs of adverse/bad effects are seen right after infusion, the patient will be monitored for at least 2 hours post infusion. The patient will have to remain locally for at least 4 weeks after the infusion. If the patient experiences any side effects, they may have to be hospitalized for evaluation and management.
Medical Test Before Treatment:
- Physical exam and History
- Blood tests to measure blood cells, kidney and liver function
- Measurements of tumor by scans and/or bone marrow studies
- Testing of blood for certain viral infections
- An ultrasound of the heart to make sure the heart function is appropriate for the study if one has not been done recently
Medical Tests During and After Treatment:
- Physical exams and History
- Blood tests to measure blood cells, kidney and liver function
- Measurements of tumor by scans and/or bone marrow studies 4 weeks after the infusion
To learn more about the way the CD70 CAR T cells are working and how long they last in the body, extra blood will be drawn. The total amount on any day is about 10 teaspoons (50 mL) or no more than 3 mL per 2.2 pounds (3 ml per kilogram) body weight in children. This volume is considered safe but may be decreased if patient is anemic (decreased number of red blood cells). This blood may be drawn from a central line. Blood will be taken before starting chemotherapy a few days prior to the cell infusion. On the day patient receives the cells, blood will be taken before the cells are given and several hours afterwards. Other blood will be drawn one week after the infusion, 2 weeks, 3 weeks, 4 weeks 6 and 8 weeks after the infusion, at 3 months, at 6 months, at 9 months, at 1 year, every 6 months for 4 years, then yearly for a total of 15 years.
If the patient has a biopsy of their tumor or bone marrow studies in the future after completing this study, the investigators may ask to have a piece of tumor or bone marrow to look for CD70 CAR T cells.
In the event of the patient's death, the investigators will request permission to perform an autopsy to learn more about the effect of this experimental treatment on the tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A - Lymphoma and Solid Tumors | Experimental | Biological: Dose Level -1, Biological: Dose Level 1 (starting dose level), Biological: Dose Level 2, Biological: Dose Level 3CD70.CAR: Three dose levels, and a possible dose level -1 in case of unexpected toxicity at dose level 1, will be evaluated for patients with lymphoma and solid tumors. Each patient will receive one T cell infusion. Dose levels will be defined based on number of transduced T cells measured by flow cytometry. The first three patients treated on the study will be adults 18 years of age or older, which can be treated in each cohort. |
| Treatment Arm B - Myeloma | Experimental | Biological: Dose Level -1, Biological: Dose Level 1 (starting dose level), Biological: Dose Level 2, Biological: Dose Level 3CD70.CAR: Three dose levels, and a possible dose level -1 in case of unexpected toxicity at dose level 1, will be evaluated for patients with myeloma. Each patient will receive one T cell infusion. Dose levels will be defined based on number of transduced T cells measured by flow cytometry. The first three patients treated on the study will be adults 18 years of age or older, which can be treated in each cohort. |
Who may qualify
- Ages
- 0 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Dose Level -1Dose Level -1: 3 x 10^5 cells/kg | Biological | Treatment Arm A - Lymphoma and Solid Tumors, Treatment Arm B - Myeloma |
| Dose Level 1 (starting dose level)Dose Level 1 (starting dose level): 1 x 10^6 cells/kg | Biological | Treatment Arm A - Lymphoma and Solid Tumors, Treatment Arm B - Myeloma |
| Dose Level 2Dose Level 2: 3 x 10^6 cells/kg | Biological | Treatment Arm A - Lymphoma and Solid Tumors, Treatment Arm B - Myeloma |
| Dose Level 3Dose Level 3: 1 x 10^7 cells/kg | Biological | Treatment Arm A - Lymphoma and Solid Tumors, Treatment Arm B - Myeloma |
Primary outcome
Dose limiting toxicity (DLT) rate
Time frame: 4 weeks post infusion
Toxicity for all patients will be evaluated using the NCI Common Toxicity Criteria Scale with the exception of CRS and immune effector cell associated neurotoxicity (ICANS). CRS and ICANS will be graded per ASTCT consensus grading criteria.
1 secondary outcome
Overall response rate
Time frame: 6-8 weeks post infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 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.
Bilal Omer, 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 Dose Level -1, Dose Level 1 (starting dose level) and Dose Level 2 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?
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: withdrawn, as of the sponsor's last update on 16 Sep 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Dose limiting toxicity (DLT) rate (time frame: 4 weeks post infusion). 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 16 Sep 2026.