Study on CTD402 for Patients with Relapsed or Hard-to-Treat T-Cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Sponsor: BIOHENG THERAPEUTICS US LLC
ClinicalTrials ID:NCT07070219
This clinical trial is testing a new treatment called CTD402 to see if it is safe and effective for patients aged 12 and older with T-Cell Acute Lymphoblastic Leukemia (T-ALL) or Lymphoblastic Lymphoma (LBL) that has returned or is difficult to treat.
Patient Parameters
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Program Overview
The TENACITY-01 study aims to find out if CTD402, a new treatment, is safe and works well for patients aged 12 and older with T-ALL or LBL that has come back or is hard to treat. Participants will receive one dose of CTD402 and will be monitored for up to 24 months to see how well the treatment works. They will also be part of a long-term follow-up study for up to 15 years to check on their health and any long-term effects.
Description
The TENACITY-01 trial is a study to test the safety and effectiveness of CTD402 in young people and adults with T-ALL or LBL that has returned or is hard to treat. The study has two parts: Phase 1b and Phase 2. In Phase 1b, about 18 participants will receive CTD402 to find the best dose. In Phase 2, about 36 participants will receive the treatment to confirm its effectiveness and safety.
The study includes several steps: a screening period, a short period of chemotherapy to prepare the body, a single dose of CTD402, and a follow-up period of up to 2 years. After receiving CTD402, participants will be monitored for their health and any side effects. They will also be part of a separate long-term follow-up study for up to 15 years to check for any long-term health effects.
Eligibility Criteria
Inclusion Criteria
- Must be 12 years or older.
- Must weigh at least 40 kilograms (about 88 pounds).
- Have T-ALL or LBL that has returned or is hard to treat, defined as:
- Disease returned or did not respond after two or more treatments.
- First relapse occurred within 12 months after initial remission.
- Relapse after a stem cell transplant, at least 100 days after the transplant.
- Have at least 5% cancer cells in the bone marrow or evidence of disease outside the bone marrow.
- Have a suitable donor for a potential future transplant.
- Have good organ function.
- Have a performance status score of 60 or higher, indicating the ability to carry out daily activities.
Exclusion Criteria
- Have genetic conditions that cause bone marrow failure.
- Have active cancer in the central nervous system.
- Have serious heart conditions, such as recent heart attack or severe heart failure.
- Have a primary immune deficiency.
- Have uncontrolled infections.
- Have a known history of HIV, hepatitis C, or syphilis.
- Have active or past hepatitis B infection.
- Test positive for certain viruses like Epstein-Barr or Cytomegalovirus at screening.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford University | 94304 | Palo Alto | California |
| University of Chicago | 60637 | Chicago | Illinois |
| Mayo Clinic - Rochester | 55905 | Rochester | Minnesota |
| Memorial Sloan Kettering Cancer Center | 11101 | New York | New York |
| Montefiore Einstein Comprehensive Cancer Center | 10467 | The Bronx | New York |
| Sarah Cannon Research Insitute | 37203 | Nashville | Tennessee |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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