TerminatedPhase 1/2

JSP191 Antibody Targeting Conditioning in SCID Patients

Stopped: Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.

United States23 participantsStarted 2017-03-20

Plain-language summary

A Phase 1/2 study to evaluate the safety, tolerability, and efficacy of an antibody conditioning regimen, known as JSP191, in patients with Severe Combined Immune Deficiency undergoing blood stem cell transplantation

Who can participate

Age range3 Months – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Typical SCID as defined by Primary Immune Deficiency Treatment Consortia including but not limited to the following subtypes:
✓. T-, B+, NK-: IL-2Rcγ deficient, JAK3-deficient (no longer enrolling)
✓. T-, B-, NK+: RAG1/2 deficient, Artemis-deficient
✓. T-, B+, NK+: IL7Rα deficient, CD3 subunit deficient, CD45 deficient (no longer enrolling) OR Variant SCID with absent or low T cell function, Omenn syndrome, Leaky SCID, Reticular dysgenesis, Adenosine deaminase deficiency, and Purine nucleoside phosphorylase deficiency may be included after consultation with the medical monitor.
✓. Patients with human leukocyte antigen (HLA) matched related or unrelated donors
✓. Adequate end organ function as defined in study protocol
✓. Age ≤ 12 years
✓. Prior donor of appropriate age (≥ 5 years old) available for re-collection of stem cells

Exclusion criteria

✕. Patients with any acute or uncontrolled infections
✕. Patients receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
✕. Patients with active malignancies
✕. Active GVHD within 6 months prior to enrollment, or on immunosuppressive therapy for GVHD

What they're measuring

Phase 1: Safety and tolerability of JSP191 as conditioning therapy in SCID patients undergoing HCT: adverse events

Timeframe: Up to 5 years post Donor Cell Transplant (28 days dose limiting toxicity period)

Phase 2: Efficacy of JSP191 as conditioning therapy in SCID patients

Timeframe: Up to 24 weeks post Donor Cell Transplant

Phase 2: Efficacy of JSP191 as conditioning therapy in SCID patients

Timeframe: Weeks 36-104 post Donor Cell Transplant

Trial details

NCT IDNCT02963064

SponsorJasper Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-07

View on ClinicalTrials.gov More SCID trials

Who can participate

Age range3 Months – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Typical SCID as defined by Primary Immune Deficiency Treatment Consortia including but not limited to the following subtypes:
✓. T-, B+, NK-: IL-2Rcγ deficient, JAK3-deficient (no longer enrolling)
✓. T-, B-, NK+: RAG1/2 deficient, Artemis-deficient
✓. T-, B+, NK+: IL7Rα deficient, CD3 subunit deficient, CD45 deficient (no longer enrolling) OR Variant SCID with absent or low T cell function, Omenn syndrome, Leaky SCID, Reticular dysgenesis, Adenosine deaminase deficiency, and Purine nucleoside phosphorylase deficiency may be included after consultation with the medical monitor.
✓. Patients with human leukocyte antigen (HLA) matched related or unrelated donors
✓. Adequate end organ function as defined in study protocol
✓. Age ≤ 12 years
✓. Prior donor of appropriate age (≥ 5 years old) available for re-collection of stem cells

Exclusion criteria

✕. Patients with any acute or uncontrolled infections
✕. Patients receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
✕. Patients with active malignancies
✕. Active GVHD within 6 months prior to enrollment, or on immunosuppressive therapy for GVHD

What they're measuring

Phase 1: Safety and tolerability of JSP191 as conditioning therapy in SCID patients undergoing HCT: adverse events

Timeframe: Up to 5 years post Donor Cell Transplant (28 days dose limiting toxicity period)

Phase 2: Efficacy of JSP191 as conditioning therapy in SCID patients

Timeframe: Up to 24 weeks post Donor Cell Transplant

Phase 2: Efficacy of JSP191 as conditioning therapy in SCID patients

Timeframe: Weeks 36-104 post Donor Cell Transplant