Is NCT07220993 recruiting in Houston, TX?

Yes, NCT07220993 is currently recruiting participants at its Houston, TX location. This t-cell acute lymphoblastic lymphoma clinical trial is actively enrolling qualified participants.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

T-cell Acute Lymphoblastic Lymphoma Clinical Trial in Houston, TX

Q: How do I join the t-cell acute lymphoblastic lymphoma clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This T-cell Acute Lymphoblastic Lymphoma Study in Houston

Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer). The body has different ways of fighting infection and disease. This study combines two different ways of fighting disease with antibodies and T cells. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, or 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 cancer; 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-CD7. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD7. CD7 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD7 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. In the laboratory, investigators have also found that T cells work better if they also add proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells grow better and last longer in the body, thus giving the cells a better chance of killing the leukemia or lymphoma cells. In this study, investigators attach the CD7 chimeric receptor with CD28 added to it to T cells. Investigators will then test how long the cells last. These CD7 chimeric receptor T cells with CD28 are investigational products not approved by the Food and Drug Administration.

Sponsor: Baylor College of Medicine

Who Can Participate

Inclusion Criteria

• Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LL), 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 leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK/T cell lymphoma, Mycosis fungoides/ Sezary Syndrome Stage IIB or higher)) AND Relapsed post-allogeneic related donor (matched, mismatched, or haploidentical) HSCT from whom allogeneic CD7.CAR T cells can be manufactured. AND

suitable for allogeneic hematopoietic stem cell transplant (HSCT)

with a suitable donor identified by a FACT accredited transplant center

willing to proceed to transplant if the CD7.CAR treatment induces complete remission and the patient/donor remain suitable candidates. Using NMDP donor assessment criteria, suitability is defined as "during the search process, a donor is fit to proceed to the next step- whether high-resolution or confirmatory HLA testing OR donor work-up." Documentation of suitability will be confirmed by the investigator prior to treatment. \*For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated.

CD7-positive tumor (≥20% CD7 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory).

Age ≤75 years old.

Hgb ≥ 7.0 g/dL (can be transfused)

Life expectancy greater than 12 weeks

Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation.

Informed consent explained to, understood by and signed by patient/LAR. Patient/LAR given copy of informed consent. Procurement

Exclusion Criteria

Active infection requiring antibiotics

Active infection with HIV

History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervical cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry. Prior HSCT Donor Procurement Criteria: • Donor must be prior hematopoietic stem cell transplant donor for patient relapsed post-allogeneic HSCT who meets patient screening eligibility criteria and has signed screening informed consent. Prior transplant donors will be screened with the standard blood bank donor questionnaire, medical history, and testing for infectious disease markers (IDMs; which may be pending at the time of blood collection). Medical history may be obtained by the patient's primary/referring transplant team if collection is being done remotely. The physician assessment, donor questionnaire, and IDMs will be reviewed by the principal investigator or appropriate designee to confirm/provide final eligibility determination and documented in the donor's medical record. • Informed consent explained to, understood by and signed by donor/LAR. Donor/LAR given copy of informed consent. Treatment Inclusion Criteria: • Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LL), 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 leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK/T cell lymphoma, Mycosis fungoides/ Sezary Syndrome Stage IIB or higher)) AND Relapsed post-allogeneic related donor (matched, mismatched, or haploidentical) HSCT AND prior allogeneic donor available to donate blood for allogeneic CD7.CAR T-cell manufacture AND

suitable for allogeneic hematopoietic stem cell transplant (HSCT)

with a suitable donor identified by a FACT accredited transplant center

CD7-positive tumor (≥20% CD7+ blasts or tumor cells by flow cytometry or immunohistochemistry (tissue) assessed in a CLIA certified Flow Cytometry/Pathology laboratory.

Age ≤75 years old.

Bilirubin less than 3 times the upper limit of normal.

AST less than 5 times the upper limit of normal.

Estimated GFR ≥ 50 mL/min.

Pulse oximetry of \> 90% on room air

Karnofsky or Lansky score of ≥ 60%.

Recovered from acute toxic effects of prior treatments (i.e. chemotherapy) at least one week before entering this study.

≥ 60 days post-allogeneic HSCT at time of treatment.

Patients must have an available partially-HLA matched allogeneic EBV-specific T cell line on a BCM IRB approved protocol which can be used as treatment in the event of uncontrolled EBV reactivation.

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. The male partner should use a condom.

Informed consent explained to, understood by, and signed by patient/guardian. Patient/guardian given copy of informed consent. Treatment Exclusion Criteria:

Currently receiving any investigational agents or having received any tumor vaccines within the previous 4 weeks.

History of hypersensitivity reactions to murine protein-containing products.

Pregnant or lactating.

Tumor in a location where enlargement could cause airway obstruction (per investigator discretion).

Clinically significant infection or uncontrolled viral reactivation of EBV, CMV, Adv, BK-virus, or HHV-6.

Evidence of acute GVHD \> Grade II or active chronic GVHD \> mild global severity score.

Currently taking corticosteroids for therapy at a dose of \>0.5mg/kg prednisone equivalent.

Patients who have received immunosuppressive treatment (IST) for GVHD within 28 days of infusion.

Patients who have received donor lymphocyte infusion (DLI) within 28 days of infusion

Any of the following cardiac criteria: Uncontrolled atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion; LVSF\<30% or LVEF\<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA III or IV. \*Study requires cardiac echocardiography confirmation of absence of these conditions within 12 months of treatment.

CNS abnormalities: Presence of CNS-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3 (unless negative by the Steinherz/Bleyer algorithm); Presence of any CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage within the past 12 months, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT07220993) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

T-cell Acute Lymphoblastic Lymphoma Treatment Options in Houston, TX

If you're searching for t-cell acute lymphoblastic lymphoma treatment options in Houston, TX, this clinical trial (NCT07220993) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced t-cell acute lymphoblastic lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all t-cell acute lymphoblastic lymphoma clinical trials near you to find additional studies recruiting in your area.

T-cell Acute Lymphoblastic Lymphoma Clinical Trial in Houston, TX

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