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Experimental CAR-T therapy targets tough blood cancers in tiny early trial

NCT ID NCT05895994

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new cell therapy called RD13-02 in just 2 people with relapsed or refractory CD7-positive blood cancers (like T-cell leukemia or lymphoma). The treatment uses specially engineered immune cells to attack cancer cells. The main goals were to check safety and see how the cells behave in the body. Because it is so small and early, we cannot draw any firm conclusions yet.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RD13-02 CAR-T cells (a type of immune cell therapy)
What this could lead to
If it works, this could point toward a new treatment option for certain hard-to-treat blood cancers.
What could go wrong
This is a very early, tiny study (only 2 people). It is too small to know if the treatment is safe or effective. Many early-stage therapies do not pan out.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

2 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 3-70 2. Diagnosis of r/r T-ALL/LBL/AML. 3. CD7 positive expression 4. Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening 5. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) \< 3×upper limit of normal, Total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl 6. Left ventricular ejection fraction ≥ 50% . 7. Baseline oxygen saturation ≥ 92% on room air. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 9. The estimated survival time is more than 3 months. 10. Subjects or their legal guardians volunteer to participate in the study and sign the informed consent. Exclusion Criteria: 1. Subjects with concomitant genetic syndromes associated with bone marrow failure states. 2. Isolated extramedullary lesions 3. Subjects with some cardiac conditions will be excluded. 4. With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3). 5. History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol. 6. History of malignancy other than non-melanoma skin cancer or carcinoma. 7. Primary immune deficiency. 8. Presence of uncontrolled infections. 9. Subjects with some anticancer therapy before CAR-T infusion will be excluded. 10. Active uncontrolled acute infections. 11. Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis. 12. Subjects who are receiving systemic steroid therapy prior to screening. 14.Having received live/attenuated vaccine within 4 weeks prior to screening. 15.History of allergy to any component of the cell therapy product. 16.Pregnant or breastfeeding women 17.Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Union Hospital, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.