CTD402 for Acute Lymphoblastic Leukemia

(TENACITY-01 Trial)

Recruiting at 6 trial locations

Overseen By Jan Davidson-Moncada, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BIOHENG THERAPEUTICS US LLC

Disqualifiers: Genetic syndromes, CNS involvement, Heart diseases, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Day 0

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a new treatment, CTD402, is safe and effective for individuals with a specific type of blood cancer called relapsed or refractory T-ALL/LBL. Participants will receive a single infusion of CTD402 and undergo close monitoring to assess their cancer's response. This trial is ideal for those whose blood cancer has returned or not responded after at least two standard treatments. To join, participants must have experienced this condition after multiple treatments and have a specific donor match ready. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that CTD402 is likely to be safe for humans?

Research shows that CTD402, a type of CAR T-cell therapy, is being tested for safety in treating certain blood cancers, specifically relapsed or hard-to-treat T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (T-LBL). Earlier studies found that patients generally tolerated CTD402 well. Some participants experienced mild to moderate side effects, which is common with many treatments, while serious side effects occurred less frequently.

This trial is in the early stages, focusing on the treatment's safety and potential risks. Current data suggest CTD402 could be safe, but further research is necessary to confirm this. Participants will be closely monitored to address any side effects promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Acute Lymphoblastic Leukemia, which often involve chemotherapy and radiation, CTD402 offers a novel approach through cell infusion. This experimental therapy uses engineered cells that are designed to target and destroy cancerous cells more precisely. Researchers are excited about CTD402 because it promises to minimize damage to healthy cells, potentially leading to fewer side effects and improved patient outcomes.

What evidence suggests that CTD402 might be an effective treatment for acute lymphoblastic leukemia?

Research shows that CTD402, which participants in this trial will receive, is a new type of CAR T-cell therapy that could help treat T-cell acute lymphoblastic leukemia (T-ALL) and lymphoma that have returned or are not responding to other treatments. Similar therapies have shown good results in attacking cancer cells, suggesting CTD402 might also be effective. This treatment uses specially designed immune cells to find and destroy cancer cells. Although complete clinical data on CTD402 is not yet available, it is designed to assist patients who haven't had success with standard treatments. Early signs suggest it could be a helpful option for those dealing with difficult cases of T-ALL and lymphoma. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals over 12 years old with a body weight of at least 40 kg who have T-ALL/LBL that has returned or hasn't responded after two treatments. They should be past their first remission within a year, or more than 100 days post-allogeneic HSCT, with adequate organ function and specific bone marrow conditions.

Inclusion Criteria

Key

I weigh at least 40 kilograms.

My condition did not improve after at least two treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 2 weeks

Lymphodepletion

Participants undergo a lymphodepleting chemotherapy regimen within 7 days prior to treatment

1 week

Treatment

Participants receive a single infusion of CTD402

Day 0

Primary Follow-up

Participants are monitored for safety and efficacy, including anti-tumor activity evaluation

up to 24 months

Long-term Follow-up

Participants are followed for survival, toxicity, RCR monitoring, and secondary malignancy

up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

• CTD402

Trial Overview The TENACITY-01 trial tests the safety and effectiveness of CTD402 UCART, a CAR T Cell Injection for those with relapsed/refractory T-ALL/LBL. Participants will receive one infusion and be monitored up to 24 months using NCCN criteria for tumor activity evaluation.

How Is the Trial Designed?

Group I: CTD402 Cell Infusion Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

BIOHENG THERAPEUTICS US LLC

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07070219

NCT07070219 | A Study of CTD402 in T-ALL/LBL Patients The goal of the TENACITY-01 clinical trial is to learn if CTD402 UCART is safe and effective for relapsed/refractory T-ALL/LBL patients. Participants with ...

2. targetedonc.com targetedonc.com/view/fda-oks-trial-of-novel-car-t-cell-therapy-in-t-all-lbl

FDA OKs Trial of Novel CAR T-Cell Therapy in T-ALL/LBL The “off-the-shelf” CAR T-cell therapy CTD402 will be evaluated in a phase 1b/2 trial for patients with T-cell acute lymphoblastic leukemia and lymphoma.

3. imvivabio.com imvivabio.com/News_Details/31.html

NEWS At this event, Bioheng Therapeutics presented the latest clinical data on its universal CAR-T product, CTD402, for the treatment of patients ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-1-2-1b-ctd402-t-all-lbl-patients-trial-nct07070219

A Study of CTD402 in T-ALL/LBL Patients A Clinical Trial to Evaluate the Safety and Effectiveness of CTD402 in Treating Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic ...

5. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/4186/534220/Clinical-Outcomes-of-Patients-with-Relapsed

Clinical Outcomes of Patients with Relapsed/Refractory B-Cell ... In trials with overall survival (OS) results (n=20, 67% of the trials), median OS was not reached in 5 trials and ranged from 7.2 to 23.7 months ...

6. library.ehaweb.org library.ehaweb.org/eha/2025/eha2025-congress/4159360/jiangtao.ren.ctd402.a.universal.anti-cd7.chimeric.antigen.receptor.t-cell.html?f=

CTD402: A UNIVERSAL ANTI-CD7 CHIMERIC ANTIGEN ... Herein we report safety and efficacy data from several Phase I/II ... ACUTE LYMPHOBLASTIC LEUKEMIA/LYMPHOBLASTIC LYMPHOMA (T-ALL/LBL).

7. bloodcancerstoday.com bloodcancerstoday.com/post/fda-approves-phase-1b-2-trial-for-ctd402-in-t-all-lbl

FDA Approves Phase 1b/2 Trial for CTD402 in T-ALL/LBL The FDA has approved an Investigational New Drug (IND) application for CTD402, a CD7-targeted universal chimeric antigen receptor T-cell (UCAR-T) therapy.